- Email: [email protected]
Prospective randomized controlled trial comparing V–Y advancement flap with primary suture methods in pilonidal disease
The American Journal of Surgery (2010) 199, 170 –177
Clinical Surgery-International
Prospective randomized controlled trial comparing V–Y advancement flap with primary suture methods in pilonidal disease Tarık Zafer Nursal, M.D.*, Ali Ezer, M.D., Kenan Çalıs¸kan, M.D., Nurkan Törer, M.D., Sedat Belli, M.D., Gökhan Moray, M.D. Bas¸kent University Department of General Surgery, Adana, Turkey KEYWORDS: Pilonidal; Flap; Surgery; Simple suture; Complication; Recurrence
Abstract BACKGROUND: An ideal treatment method for the widely prevalent pilonidal sinus disease is not yet available. The most commonly practiced technique is simple closure following resection of the effected tissue. However, high recurrence rates in some series have led to the search for other methods. One of these methods is the V–Y advancement flap (VYAF), which in theory results in the flattening of the natal cleft without tension in the suture line. METHODS: In this prospective randomized controlled study, the VYAF method was compared to 2 simple primary closure techniques. In 238 patients, following resection, in the AL (all layers) group, all layers were closed with polypropylene sutures. In the SS (subcutaneous suture) group, polyglactin subcutaneous sutures were used to approximate the wound edges. Skin was closed separately in the SS group. In addition, demographic variables, past history, physical examination findings, defect dimensions, and wound tension were recorded. RESULTS: Surgical site infection was observed in 23.9%, 17.4%, and 10.2% of the patients in AL, SS, and VYAF groups, respectively (P ⫽ .129). Early wound dehiscence without infection was detected in 11.9%, 7.4%, and 10.2% of the patients in groups AL, SS, and VYAF, respectively (P ⫽ .665). Mean follow-up was 29.7 ⫾ 15.6 months. Survival (time without recurrence) was not significantly different between groups (P ⫽ .648). In the whole group, independent predictors of recurrence according to logistic regression analysis were younger age, recurrent disease, presence of discharge on physical examination, and development of postoperative surgical site infection. CONCLUSIONS: VYAF is not superior to simple primary closure techniques in terms of postoperative complications, recurrence, and patient satisfaction. For most cases, simple primary closure would suffice. Patients should be informed of the increased risk of recurrence if any of the independent predictors (being a recurrent case, presence of discharge, development of postoperative infection) are present. © 2010 Elsevier Inc. All rights reserved.
* Corresponding author. Tel.: ⫹90 322 3272727 (⫻ 1067). E-mail address: [email protected] Manuscript received October 9, 2008; revised manuscript November 24, 2008
0002-9610/$ - see front matter © 2010 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2008.12.030
Pilonidal cysts, related chronically draining sinuses with exacerbating abscesses, widely effect the general population.1,2 Over some years of debate regarding the etiopathogenesis of pilonidal sinus disease, the acquired theory is generally accepted.3 Unfortunately, no single method is successful in treating the whole spectrum of pilonidal dis-
T.Z. Nursal et al.
Flap versus simple closure in pilonidal disease
ease. Therefore, numerous techniques have been devised for the cure of this condition. Although the wound excision– open healing method results in a lower recurrence rate, primary closure methods offer the advantage of earlier healing.4 Simple closure after wound excision is the most commonly used technique.5 To avoid complications and recurrences observed following primary closure, flattening of the natal cleft has been advocated.3,5 To achieve this goal, various flap rotation and advancement methods are being used. The V–Y advancement flap (VYAF) has been reported to have a high success rate, with recurrence rates ranging from 0% to 6%.3,6 –9 In this first-time study we aimed to compare the VYAF method with 2 types of simple primary closure methods. In addition, other factors such as the mechanical properties of the wound were investigated with regard to recurrence.
Patients and Methods Protocol The study was approved by the research council and ethics committee of our university (Study No. KA 02/61). All consecutive patients admitted with chronic pilonidal sinus disease who were classified as being appropriate for primary closure and who gave informed consent were included in the study. Patients who were admitted with acute abscesses were excluded. In addition to demographic variables, information regarding the presence and duration of pain and discharge, previous surgical drainage and pilonidal disease operation, and history of previous use of antibiotics for the pilonidal disease was obtained. During physical examination, the presence of discharge and hair in the pits, location and number of pits, and endurated areas were also noted. The stage of the disease was further recorded according to a previously published method (Chavoin classification).10 In Chavoin stage I, in the asymptomatic patient, the midline pits are latent with no discharge and pain. In stage II, the patient seeks medical advice due to discharge from midline pits, which sometimes include hair. Acute abscess in the midline is classified as stage III. In stage IV, there is chronic discharge with painful swellings accompanied by lateral fistulas.
Primary and secondary outcomes The groups were compared regarding postoperative results: surgical site infections, early wound failure (without infection), recurrence, and patient satisfaction. As a secondary outcome, the independent factors related to recurrence were investigated.
171
Power analysis and randomization Recurrence rates following primary suture closures have been observed in up to 20% of patients.5 With a power of .80 and a probability level of .05, the sample size to detect a decrease of 75% (ie, recurrence rate of 5%) was calculated to be 75 for each group.11 Included patients were randomized into 3 groups by the blocked rank randomization method. The random number generator of the computer software (MS Excel, 2003, Microsoft Corp, Redmond, WA) was used to create the blocked lists. Blinding was not possible as the surgical procedures explained in detail below are visually apparent.
Surgical procedures The patient was placed in the prone position following general or spinal anesthesia. The buttocks were taped apart. Then, the surgical site was prepared and draped. Methylene blue was instilled into the pits. Following excision of all sinuses and related cavities to the level of postsacral fascia, physical properties of the wound were further recorded. The volume of the excised tissue was measured as follows. A small sized surgical cup was placed in a bigger container. Saline was filled to the top of the small cup and the tissue was immersed gently. Then, the tissue was removed and the overflow saline that was contained in the bigger container was measured in milliliters by a syringe and recorded as the tissue volume. Later, the buttocks were freed from the tape and the table was placed neutrally, ie, no side or horizontal inclination. The postsacral defect was then filled with saline until the fluid overflowed. The volume of the remaining saline in the defect cavity was again measured by a syringe, and recorded as the defect volume. The width, length, and depth of the wound were measured and recorded. To quantify the mechanical forces that may pull apart the wound in the healing phase, the tension to stabilize the wound edges in the neutral position was measured. For this, 2 hooks were placed at the edges of the wound and 1 spring scale for each hook was attached the end of the hook. The spring scales attached to the hooks were then pulled to each other horizontally until the wound edges approximated. The values read on 2 scales were added and recorded in grams as the tension of the wound. The VYAF method was used in the first group (VYAF group). In this technique, a triangle is drawn with the base forming the lateral wall of the sacral defect. The sides of the triangle (V) are incised down to the gluteal muscle, including the fascia. The mobility of the fasciocutaneous flap is then tested. If needed, gluteal muscle fibers at the apex are further separated. Following the release of the flap, a strip (⬎1.5 cm) of skin is removed from the medial edge, leaving a block of bare fatty subcutaneous tissue.3 This excess block of subcutaneous tissue is folded into the defect. The medial flap edge is sutured to the contralateral cavity edge by absorbable sutures (no. 2/0 polyglactin 910 [Ethicon, Edin-
172
Figure 1
The American Journal of Surgery, Vol 199, No 2, February 2010
Diagram of the V–Y advancement flap method.
burgh, UK]) placed in the dermis (Fig. 1). The lateral transverse defect that is formed when the island flap was moved medially is closed horizontally, thus giving the final scar a horizontal “Y” shape. The skin was closed by interrupted polypropylene sutures. In the second group (group AL), all layers, including the skin, of the open wound were closed by no. 1 polypropylene (Dog˘san, Istanbul, Turkey) sutures (Fig. 2). In the third group (group SS), subcutaneous deep sutures (no. 2/0 polyglactin 910) were placed and the skin was closed separately (Fig. 3). No drains were placed in any of the 3 groups.
Follow-up Patients were invited for observation on the 4th and 7th days. Sutures were removed at the 7th postoperative day and the surgical site was inspected for infection. Surgical site infection was recorded according to the hospital infection control practices advisory committee guideline.12 Also, early wound failure (wound dehiscence) without overt infection, ie, draining pus, hyperemia, swelling, and inflam-
Figure 3 In group SS (subcutaneous sutures), polyglactin 910 sutures were used to approximate the edges of the wound.
mation, was assessed. Time to return to work or everyday activity for the unemployed was recorded. Patients were encouraged to visit at any time during follow-up if any problems occurred. They were routinely examined at the 1st and 6th postoperative months and yearly thereafter. During these visits, physical examinations were performed to identify any recurrence. Moreover, patient satisfaction, graded into 5 categories with the minimum score (0) being very dissatisfied and the maximum (4) being very satisfied, was also recorded. Patients were also asked if they were comfortable in performing everyday physical activities, would accept the same operation again if the need arose, and would suggest the same type of operation to an acquaintance.
Statistical analysis Chi-square analysis and analysis of variance (ANOVA) were used for categorical variables and continuous variables, respectively, during assessment of possible differences between groups. Survival, ie, time to recurrence between groups, was assessed by the Kaplan–Meier method with log-rank analysis to identify any significant difference. To identify the factors that correlated with recurrence, chisquare analysis and Fisher exact tests were used where appropriate for categorical variables. For assessing continuous variables, Student t test was used. A P value of ⬍.05 was accepted as significant.
Results
Figure 2 Polypropylene all layers sutures are used for group AL (all layers).
Three hundred sixty-three patients were operated on for pilonidal sinus between November 2001 and June 2007 in our department. Of these, 67 patients refused to be included in the study. A different type of operation was performed in 44 of the patients at the discretion of the surgeon. In 14 patients, protocol violations occurred. Overall, 238 patients were included in the study. The majority of the patients
T.Z. Nursal et al. Table 1
Flap versus simple closure in pilonidal disease
173
Demographic variables, symptoms, physical findings, and stage of the disease according to the groups
Sex (male:female) Age (years, ⫾SD) BMI* Symptom Presence of pain Presence of discharge Antibiotic† Drainage‡ Recurrent cases Finding Presence of discharge Presence of hair Presence of lateral sinuses Presence of midline swelling Presence of lateral swelling Chavoin classification Stage I Stage II Stage III§ Stage IV
Group AL
Group SS
Group VYAF
P value
65:18 24.9 ⫾ 6.9 24.8 ⫾ 3.5
58:20 26.1 ⫾ 7.3 25.2 ⫾ 3.6
66:11 27.5 ⫾ 9.9 25.7 ⫾ 3.8
.207 .146 .327
54 68 36 16 8
(65.9%) (82.9%) (43.9%) (19.5%) (9.8%)
64 59 34 23 2
(83.1%) (77.6%) (44.7%) (30.3%) (2.6%)
60 66 36 14 8
(77.9%) (86.8%) (47.4%) (18.4%) (10.4%)
.034 .325 .902 .153 .127
27 39 24 5 13
(37.5%) (54.9%) (33.3%) (7.0%) (18.1%)
27 30 12 11 11
(39.1%) (42.9%) (18.2%) (17.2%) (17.5%)
31 39 28 9 18
(44.3%) (54.9%) (40.0%) (12.9%) (25.7%)
.692 .255 .019 .194 .409
4 (5.3%) 41 (54.7%) — 30 (40.0%)
.338
6 (7.6%) 44 (55.7%) — 29 (36.7%)
7 (9.2%) 50 (65.8%) — 19 (25.0%)
Note. Percentages may not add up properly as some of the data are incomplete among the variables. *BMI: body mass index (weight [kg]/height2 [m]). †Previous use of antibiotic for pilonidal disease. ‡Previous history of surgical drainage for pilonidal disease. §Acute abscess; closure is not justified; these patients are excluded.
were male (n ⫽ 189, 79.4%) and the mean age (⫾SD) was 26.2 ⫾ 8.2 years. There were 83, 78, and 77 patients in groups AL (34.9%), SS (32.8), and VYAF (32.4%), respectively. There was no difference among the groups regarding demographic variables, symptoms, ratio of recurrent cases, physical findings, and stage of the disease (Table 1). Twelve surgeons performed the operations. Surgeons who had performed fewer than 10 operations were grouped together. This data stratification process left 9 surgeons (including the group of surgeons who had performed fewer than 10 operations). Although the study group was random-
Table 2
ized, one surgeon performed exclusively primary suture methods (AL ⫽ 9 and SS ⫽ 1) (P ⫽ .008). However, according to the layered chi-square analysis, there was no difference between the type of surgery and recurrence as layered across the surgeons. Some surgical data were collected during surgery as detailed in the Methods. The results according to the groups are depicted in Table 2. Wound healing data and patient satisfaction were also recorded during the postoperative period (Table 3). Of the study group, 193 patients (81.1%) were monitored for a mean (⫾SD) duration of 29.7 ⫾ 15.6 months. Kaplan-
Surgical variables
Type of anesthesia General Spinal Local Tissue volume (mL) Defect volume (mL) Length of the defect (mm) Width of the defect (mm) Depth of the defect (mm) Tension of the wound (g) Anal distance* (mm) Duration of surgery (min) LOS (d)†
Group AL
Group SS
Group VYAF
40 (48.2%) 42 (50.6%) 1 (1.2%) 19.7 ⫾ 16.3 31.8 ⫾ 28.9 64.9 ⫾ 19.5 28.7 ⫾ 13.4 30.7 ⫾ 9.6 604.3 ⫾ 645.8 56.9 ⫾ 18.2 47.9 ⫾ 14.7 1.2 ⫾ .4
48 (62.3%) 28 (36.4%) 1 (1.3%) 26.3 ⫾ 21.9 30.5 ⫾ 21.9 64.9 ⫾ 20.2 29.6 ⫾ 13.9 31.9 ⫾ 13.5 546.9 ⫾ 368.7 51.0 ⫾ 14.2 52.7 ⫾ 19.6 1.2 ⫾ .4
42 (56.0%) 33 (44.0%) 0 (0%) 28.8 ⫾ 21.4 32.0 ⫾ 23.0 79.2 ⫾ 19.9 31.6 ⫾ 12.4 33.7 ⫾ 11.9 629.1 ⫾ 440.6 51.5 ⫾ 17.6 77.0 ⫾ 22.9 1.3 ⫾ .9
P value .301
*The distance of the lowest margin of the defect from the anus. †Hospital length of stay.
.018 .926 ⬍ .001 .416 .284 .618 .210 ⬍ .001 .250
174
The American Journal of Surgery, Vol 199, No 2, February 2010
Table 3
Postoperative results and patient satisfaction variables according to the study groups
Infection Wound dehiscence Satisfaction* Recommendation† Agree to reoperation‡ Yes No Perhaps/not sure Comfortable§ Time to start work (d) Recurrence
Group AL
Group SS
Group VYAF
P value
16 (23.9%) 8 (11.9%) 3.5 ⫾ .9 53 (86.9%)
12 (17.4%) 5 (7.4%) 3.6 ⫾ .8 56 (93.3%)
6 (10.2%) 6 (10.2%) 3.6 ⫾ .9 50 (92.6%)
.129 .665 .958 .407 .038
49 (81.7%) 9 (15.0%) 2 (3.3%) 42 (85.7%) 17.2 ⫾ 17.6 8 (12.3%)
51 (85.0%) 4 (6.7%) 5 (8.3%) 45 (86.5%) 11.5 ⫾ 10.7 7 (10.4%)
50 (94.3%) 3 (5.7%) 0 41 (82.0%) 15.1 ⫾ 16.9 10 (16.4%)
.796 .250 .595
Note. Percentages may not add up properly as some of the data are incomplete among the variables. *As graded from 0 (very dissatisfied) to 4 (very satisfied). †Recommend the same operation to an acquaintance. ‡Patients were asked if they would agree to the same operation if the need arose. §Patients were asked if they were comfortable in everyday physical activities.
Meier survival analysis was performed to assess the success of the type of surgery, ie, time to recurrence (Fig. 4). Univariate analyses were performed to identify the factors that may be correlated with recurrence (Table 4). To identify the independent variables correlated with the recurrence, logistic regression analysis was performed by entering the significant and nearly significant variables into the model. Of the entered variables, younger age, being a recurrent case, presence of discharge on physical examination, and development of surgical site infection postoperatively were found to be independent predictors of recurrence.
As expected, patients with recurrence were less likely to be satisfied with the operation. Similarly they were less eager to agree to a possible re-operation and to recommend this type of surgery to an acquaintance (Table 4).
Comments Although Mayo described a sinus with hair inside in 1833, it was Hodge, in 1880, who suggested the term pi-
Figure 4 Kaplan-Meier plot of the recurrence as stratified by the study groups. Bold black line: VYAF; bold gray line: AL; thin black line: SS groups. Log-rank analysis (Mantel–Cox); P ⫽ .648.
T.Z. Nursal et al. Table 4
Flap versus simple closure in pilonidal disease
175
Variables with possible correlation with the primary outcome (recurrence)
Sex (male:female) Age (years, ⫾SD) BMI* Symptom Presence of pain Presence of discharge Antibiotic† Drainage‡ Recurrent cases Finding Presence of discharge Presence of hair Presence of lateral sinuses Presence of midline swelling Presence of lateral swelling Chavoin classification Stage I Stage II Stage IV Type of anesthesia General Spinal Local Tissue volume (mL) Defect volume (mL) Length of the defect (mm) Width of the defect (mm) Depth of the defect (mm) Tension of the wound (g) Anal distance§ (mm) Duration of surgery (min.) LOS (d)¶ Infection Wound dehiscence Satisfaction\\ Recommendation** Agree to reoperation†† Yes No Perhaps/not sure Comfortable‡‡ Time to start work (d)
No recurrence
Recurrence
135:32 26.9 ⫾ 8.3 25.8 ⫾ 3.7
18:8 21.5 ⫾ 7.4 23.6 ⫾ 3.2
.174 .002 .008
.044 .874
41 133 76 43 11
(24.7%) (81.1%) (46.3%) (26.2%) (6.6%)
7 24 13 4 6
(26.9%) (92.3%) (50.0%) (15.4%) (23.1%)
.808 .263 .728 .234 .015
.031
55 75 41 22 25
(36.9%) (50.0%) (27.7%) (15.2%) (17.2%)
15 10 6 0 4
(71.4%) (47.6%) (28.6%)
.003 .838 .934 .079 .766 .445
15 (9.3%) 99 (61.1%) 48 (29.6%)
P (univariate)
(19.0%)
P (multivariate)
.013 .998
1 (3.8%) 19 (73.1%) 6 (23.1%) .593
93 (56.0%) 71 (42.8%) 2 (1.2%) 24.5 ⫾ 20.9 30.5 ⫾ 24.9 68.7 ⫾ 20.2 29.6 ⫾ 12.6 31.4 ⫾ 10.7 607.0 ⫾ 549.4 53.5 ⫾ 16.9 57.6 ⫾ 22.0 1.2 ⫾ .4 23 (13.8%) 18 (10.5%) 3.7 ⫾ .7 145 (94.8%)
16 (64.0%) 9 (36.0%) 0 27.1 ⫾ 17.3 44.1 ⫾ 32.5 77.4 ⫾ 21.7 31.2 ⫾ 17.8 36.7 ⫾ 11.4 658.7 ⫾ 446.1 54.4 ⫾ 17.7 59.2 ⫾ 19.5 1.5 ⫾ 1.4 8 (33.3%) 5 (26.3%) 2.3 ⫾ 1.4 14 (63.6)
138 (91.4%) 7 (4.6%) 6 (4.0%) 119 (91.5%) 15.0 ⫾ 15.7
12 (54.5%) 9 (40.9%) 1 (4.5%) 9 (42.9%) 11.5 ⫾ 14.1
.559 .025 .081 .682 .027 .674 .863 .716 .198 .032 .059 ⬍ .001 ⬍ .001 ⬍ .001
.490 .309 .376
.033 .502
⬍ .001 .404
Note. Percentages may not add up properly as some of the data are incomplete among the variables. *BMI: body mass index (weight [kg]/height2 [m]). †Previous use of antibiotic for pilonidal disease. ‡Previous history of surgical drainage for pilonidal disease. §The distance of the lowest margin of the defect from the anus. ¶Hospital length of stay. \\As graded from 0 (very dissatisfied) to 4 (very satisfied). **Recommend the same operation to an acquaintance. ††Patients were asked if they would agree to the same operation if the need arose. ‡‡Patients were asked if they were comfortable in everyday physical activities.
lonidal sinus.1 It is a common disease with a reported incidence of 26/100,000.13 Similar to our cohort, the reported mean age of patients is approximately 30 years and almost 80% are male.1 In this group (young males) the prevalence of pilonidal disease was reported to be as high as 88/1,000.2
Although previously a congenital origin was suggested for the etiology, the acquired theory is widely accepted today. The hair at the opposite site of the natal cleft and accumulated loose hair is constantly burrowed to the skin of the gluteal region with the movement of the buttocks. Ongoing irritation results in micro-abscesses, and the suction
176 movement of the gluteal region further pulls the hair in these abscesses, which further enlarge.1,3 Among the numerous treatment methods, flattening of the natal cleft has been advocated as a means of decreasing recurrence.5 Various flap procedures have been devised for this goal. One of the easier methods of flap operations is the VYAF. Experience with the VYAF method for pilonidal disease in the literature generally consists of case series.6 –9 One of these studies, although with a prospectively controlled design, only compared 2 modifications of VYAF.7 These studies reported recurrence rates ranging from 0% to 6%. To our knowledge, there is only 1 controlled study involving VYAF.14 The authors in the mentioned study compared VYAF to another flap method (Limberg flap). The Limberg flap was concluded to be the better method. However, this retrospective study has a number of limitations. First, it was not randomized. The surgeons, whose distribution among groups not mentioned, chose the type of surgery they would perform. Furthermore, patients with multiple recurrences were excluded from the study. Although the statement of the superiority of the Limberg flap might be true, the design limitations preclude definite conclusions. Primary closure is the most common method used to treat pilonidal disease.5 Success as defined by the recurrence rate varies between 0% to almost 40%. Although the technique is criticized by both the minimalist approach advocates and the more aggressive flap operators, a more recent study documenting the results of at least 5 years of follow-up reported a recurrence rate of a very acceptable 3% following midline primary closure.15 To the best of our knowledge, the present study is the first prospectively randomized controlled study comparing VYAF to another technique, ie, the simple primary closure. The groups were comparable in terms of demographics (Table 1). The uneven distribution of the 2 variables (symptom: presence of pain and presence of lateral sinuses) among the groups might have had a confounding effect to the primary outcome (recurrence). Similarly, the distribution of the surgeons was uneven among the groups. Therefore, layered chi-square analysis was performed for these variables, which revealed no difference. The resected tissue volume was smaller in the AL group and the length of the remaining defect was longer in the VYAF group. These factors were also not independent predictors of recurrence (Table 4). Being a more complex operation than the primary closure methods, VYAF, as expected, took longer to perform. Although retrospective studies and case series reported promising results, we were not able to show that VYAF is a better method than simple closure techniques. There was no statistically significant difference in the rate of early wound problems and recurrences between the groups. In this study we have included all probable patients who are eligible to have a primary closure as decided by the surgeon. In the literature, however, VYAF is generally preferred for the difficult, chronic and recurrent cases. It may be argued
The American Journal of Surgery, Vol 199, No 2, February 2010 that the focus of the study should be this difficult group. However, it is not possible to compare simple closure with VYAF in these difficult cases. Primary closure usually is not technically possible and these patients would have already been directed to another procedure rather than simple primary closure. In an eligible patient for primary closure, a method (VYAF, Limber, other flap) addressing the pathophysiology of the disease process, ie, flattening of the natal cleft without tension, may theoretically decrease complications. This idea formed the basis of our study. Nevertheless, as a subgroup, we have further analyzed our data for the chronically inflamed cases with lateral draining sinuses (Chavoin stage IV), and for recurrent cases. Although these were difficult cases, primary closure was technically deemed possible and was included in the study. In these cases there still was not any difference between groups in terms of recurrence (P ⫽ .856 and .689, respectively). One potential drawback of this study might have been the inclusion of 2 primary closure methods, which might have diluted the study power and the results. However, the necessary power analysis and sample size calculations have been performed initially. The sample size is sufficient for the mentioned parameters. A limitation of the present study is the use of nonstandard methods to assess the quality of life. Although our assessment may not be as sensitive as a generic form such as the SF-36, it is simple and quickly done. With our method, we could not show any significant difference between groups regarding the quality of life. Another aspect of this study was to delineate any independent factors that would predict recurrence. For this, we have recorded many variables, including the dynamic mechanical properties of the defect (Table 4). Although a number of factors were correlated with recurrence, only younger age, recurrent cases, and finding of discharge in the physical examination were independent predictors of recurrence among the preoperative factors. A new classification system was proposed recently that takes into account the previous history of pilonidal disease, ie, recurrence.16 This classification might better predict the prognosis for pilonidal disease surgery as we have shown that previous recurrence is an independent predictor of recurrence. Presence of infection is a common problem that prolongs the convalescence period and delays the return to full activity.5 However as shown by our data, its importance lies not only in the early postoperative period. Development of surgical site infection is the only variable correlated with recurrence among the postoperative factors. Therefore, strict adherence to preventive measures for infection control should be exercised in pilonidal sinus surgery.
Conclusions Patients who are admitted with pilonidal disease should be informed of an increased risk of recurrence if they have
T.Z. Nursal et al.
Flap versus simple closure in pilonidal disease
a recurrent disease, draining sinuses, and infection develops following the operation. Although theoretically appealing, the VYAF technique does not offer any advantages compared to the simpler primary closure techniques. VYAF technique, however, may be needed especially in patients with large defects that cannot be mechanically approximated with primary closure. On the other hand, as this is the only prospectively randomized controlled study, further properly designed studies comparing VYAF to other methods are needed.
References 1. Chintapatla S, Safarani N, Kumar S, et al. Sacrococcygeal pilonidal sinus: historical review, pathological insight and surgical options. Tech Coloproctol 2003;7:3– 8. 2. Akinci OF, Bozer M, Uzunkoy A, et al. Incidence and aetiological factors in pilonidal sinus among Turkish soldiers. Eur J Surg 1999; 165:339 – 42. 3. Schoeller T, Wechselberger G, Otto A, et al. Definite surgical treatment of complicated recurrent pilonidal disease with a modified fasciocutaneous V–Y advancement flap. Surgery 1997;121:258 – 63. 4. McCallum IJ, King PM, Bruce J. Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and metal-analysis. BMJ 2008;19:868 –71. 5. Petersen S, Koch R, Stelzner S, et al. Primary closure techniques in chronic pilonidal sinus: a survey of the results of different surgical approaches. Dis Colon Rectum 2002;45:1458 – 67.
177
6. Khatri VP, Espinosa MH, Amin AK. Management of recurrent pilonidal sinus by simple V–Y fasciocutaneous flap. Dis Colon Rectum 1994;37:1232–5. 7. Berkem H, Topaloglu S, Ozel H, et al. V–Y advancement flap closures for complicated pilonidal sinus disease. Int J Colorectal Dis 2005;20: 343– 8. 8. Dilek ON, Bekereciog˘lu M. Role of simple advancement flap in the treatment of complicated pilonidal sinus. Eur J Surg 1998;164:961– 4. 9. Saray A, Dirlik M, Caglikulekci M, et al. Advancement fasciocutaneous flap for treatment of chronic pilonidal sinus disease. Scand J Plast Reconstr Surg Hand Surg 2002;36:80 – 4. 10. Quinodoz PD, Chilcott M, Grolleau JL, et al. Surgical treatment of sacrococcygeal pilonidal sinus disease by excision and skin flaps: the Toulouse experience. Eur J Surg 1999;165:1061–5. 11. Dupont WD, Plummer WD. PS power and sample size program available for free on the Internet. Control Clin Trials 1997;18:274. 12. Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20: 250 –78. 13. Søndenaa K, Andersen E, Nesvik I, et al. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis 1995;10:39 – 42. 14. Unalp HR, Derici H, Kamer E, et al. Lower recurrence rate for Limberg v flap for pilonidal sinus. Dis Colon Rectum 2007;50: 1436 – 44. 15. Tocchi A, Mazzoni G, Bononi M, et al. Outcome of chronic pilonidal disease treatment after ambulatory plain midline excision and primary suture. Am J Surg 2008;196:28 –33. 16. Tezel E. A new classification according to navicular area concept for sacrococcygeal pilonidal disease. Colorectal Dis 2007;9: 575– 6.
Clinical Surgery-International
Prospective randomized controlled trial comparing V–Y advancement flap with primary suture methods in pilonidal disease Tarık Zafer Nursal, M.D.*, Ali Ezer, M.D., Kenan Çalıs¸kan, M.D., Nurkan Törer, M.D., Sedat Belli, M.D., Gökhan Moray, M.D. Bas¸kent University Department of General Surgery, Adana, Turkey KEYWORDS: Pilonidal; Flap; Surgery; Simple suture; Complication; Recurrence
Abstract BACKGROUND: An ideal treatment method for the widely prevalent pilonidal sinus disease is not yet available. The most commonly practiced technique is simple closure following resection of the effected tissue. However, high recurrence rates in some series have led to the search for other methods. One of these methods is the V–Y advancement flap (VYAF), which in theory results in the flattening of the natal cleft without tension in the suture line. METHODS: In this prospective randomized controlled study, the VYAF method was compared to 2 simple primary closure techniques. In 238 patients, following resection, in the AL (all layers) group, all layers were closed with polypropylene sutures. In the SS (subcutaneous suture) group, polyglactin subcutaneous sutures were used to approximate the wound edges. Skin was closed separately in the SS group. In addition, demographic variables, past history, physical examination findings, defect dimensions, and wound tension were recorded. RESULTS: Surgical site infection was observed in 23.9%, 17.4%, and 10.2% of the patients in AL, SS, and VYAF groups, respectively (P ⫽ .129). Early wound dehiscence without infection was detected in 11.9%, 7.4%, and 10.2% of the patients in groups AL, SS, and VYAF, respectively (P ⫽ .665). Mean follow-up was 29.7 ⫾ 15.6 months. Survival (time without recurrence) was not significantly different between groups (P ⫽ .648). In the whole group, independent predictors of recurrence according to logistic regression analysis were younger age, recurrent disease, presence of discharge on physical examination, and development of postoperative surgical site infection. CONCLUSIONS: VYAF is not superior to simple primary closure techniques in terms of postoperative complications, recurrence, and patient satisfaction. For most cases, simple primary closure would suffice. Patients should be informed of the increased risk of recurrence if any of the independent predictors (being a recurrent case, presence of discharge, development of postoperative infection) are present. © 2010 Elsevier Inc. All rights reserved.
* Corresponding author. Tel.: ⫹90 322 3272727 (⫻ 1067). E-mail address: [email protected] Manuscript received October 9, 2008; revised manuscript November 24, 2008
0002-9610/$ - see front matter © 2010 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2008.12.030
Pilonidal cysts, related chronically draining sinuses with exacerbating abscesses, widely effect the general population.1,2 Over some years of debate regarding the etiopathogenesis of pilonidal sinus disease, the acquired theory is generally accepted.3 Unfortunately, no single method is successful in treating the whole spectrum of pilonidal dis-
T.Z. Nursal et al.
Flap versus simple closure in pilonidal disease
ease. Therefore, numerous techniques have been devised for the cure of this condition. Although the wound excision– open healing method results in a lower recurrence rate, primary closure methods offer the advantage of earlier healing.4 Simple closure after wound excision is the most commonly used technique.5 To avoid complications and recurrences observed following primary closure, flattening of the natal cleft has been advocated.3,5 To achieve this goal, various flap rotation and advancement methods are being used. The V–Y advancement flap (VYAF) has been reported to have a high success rate, with recurrence rates ranging from 0% to 6%.3,6 –9 In this first-time study we aimed to compare the VYAF method with 2 types of simple primary closure methods. In addition, other factors such as the mechanical properties of the wound were investigated with regard to recurrence.
Patients and Methods Protocol The study was approved by the research council and ethics committee of our university (Study No. KA 02/61). All consecutive patients admitted with chronic pilonidal sinus disease who were classified as being appropriate for primary closure and who gave informed consent were included in the study. Patients who were admitted with acute abscesses were excluded. In addition to demographic variables, information regarding the presence and duration of pain and discharge, previous surgical drainage and pilonidal disease operation, and history of previous use of antibiotics for the pilonidal disease was obtained. During physical examination, the presence of discharge and hair in the pits, location and number of pits, and endurated areas were also noted. The stage of the disease was further recorded according to a previously published method (Chavoin classification).10 In Chavoin stage I, in the asymptomatic patient, the midline pits are latent with no discharge and pain. In stage II, the patient seeks medical advice due to discharge from midline pits, which sometimes include hair. Acute abscess in the midline is classified as stage III. In stage IV, there is chronic discharge with painful swellings accompanied by lateral fistulas.
Primary and secondary outcomes The groups were compared regarding postoperative results: surgical site infections, early wound failure (without infection), recurrence, and patient satisfaction. As a secondary outcome, the independent factors related to recurrence were investigated.
171
Power analysis and randomization Recurrence rates following primary suture closures have been observed in up to 20% of patients.5 With a power of .80 and a probability level of .05, the sample size to detect a decrease of 75% (ie, recurrence rate of 5%) was calculated to be 75 for each group.11 Included patients were randomized into 3 groups by the blocked rank randomization method. The random number generator of the computer software (MS Excel, 2003, Microsoft Corp, Redmond, WA) was used to create the blocked lists. Blinding was not possible as the surgical procedures explained in detail below are visually apparent.
Surgical procedures The patient was placed in the prone position following general or spinal anesthesia. The buttocks were taped apart. Then, the surgical site was prepared and draped. Methylene blue was instilled into the pits. Following excision of all sinuses and related cavities to the level of postsacral fascia, physical properties of the wound were further recorded. The volume of the excised tissue was measured as follows. A small sized surgical cup was placed in a bigger container. Saline was filled to the top of the small cup and the tissue was immersed gently. Then, the tissue was removed and the overflow saline that was contained in the bigger container was measured in milliliters by a syringe and recorded as the tissue volume. Later, the buttocks were freed from the tape and the table was placed neutrally, ie, no side or horizontal inclination. The postsacral defect was then filled with saline until the fluid overflowed. The volume of the remaining saline in the defect cavity was again measured by a syringe, and recorded as the defect volume. The width, length, and depth of the wound were measured and recorded. To quantify the mechanical forces that may pull apart the wound in the healing phase, the tension to stabilize the wound edges in the neutral position was measured. For this, 2 hooks were placed at the edges of the wound and 1 spring scale for each hook was attached the end of the hook. The spring scales attached to the hooks were then pulled to each other horizontally until the wound edges approximated. The values read on 2 scales were added and recorded in grams as the tension of the wound. The VYAF method was used in the first group (VYAF group). In this technique, a triangle is drawn with the base forming the lateral wall of the sacral defect. The sides of the triangle (V) are incised down to the gluteal muscle, including the fascia. The mobility of the fasciocutaneous flap is then tested. If needed, gluteal muscle fibers at the apex are further separated. Following the release of the flap, a strip (⬎1.5 cm) of skin is removed from the medial edge, leaving a block of bare fatty subcutaneous tissue.3 This excess block of subcutaneous tissue is folded into the defect. The medial flap edge is sutured to the contralateral cavity edge by absorbable sutures (no. 2/0 polyglactin 910 [Ethicon, Edin-
172
Figure 1
The American Journal of Surgery, Vol 199, No 2, February 2010
Diagram of the V–Y advancement flap method.
burgh, UK]) placed in the dermis (Fig. 1). The lateral transverse defect that is formed when the island flap was moved medially is closed horizontally, thus giving the final scar a horizontal “Y” shape. The skin was closed by interrupted polypropylene sutures. In the second group (group AL), all layers, including the skin, of the open wound were closed by no. 1 polypropylene (Dog˘san, Istanbul, Turkey) sutures (Fig. 2). In the third group (group SS), subcutaneous deep sutures (no. 2/0 polyglactin 910) were placed and the skin was closed separately (Fig. 3). No drains were placed in any of the 3 groups.
Follow-up Patients were invited for observation on the 4th and 7th days. Sutures were removed at the 7th postoperative day and the surgical site was inspected for infection. Surgical site infection was recorded according to the hospital infection control practices advisory committee guideline.12 Also, early wound failure (wound dehiscence) without overt infection, ie, draining pus, hyperemia, swelling, and inflam-
Figure 3 In group SS (subcutaneous sutures), polyglactin 910 sutures were used to approximate the edges of the wound.
mation, was assessed. Time to return to work or everyday activity for the unemployed was recorded. Patients were encouraged to visit at any time during follow-up if any problems occurred. They were routinely examined at the 1st and 6th postoperative months and yearly thereafter. During these visits, physical examinations were performed to identify any recurrence. Moreover, patient satisfaction, graded into 5 categories with the minimum score (0) being very dissatisfied and the maximum (4) being very satisfied, was also recorded. Patients were also asked if they were comfortable in performing everyday physical activities, would accept the same operation again if the need arose, and would suggest the same type of operation to an acquaintance.
Statistical analysis Chi-square analysis and analysis of variance (ANOVA) were used for categorical variables and continuous variables, respectively, during assessment of possible differences between groups. Survival, ie, time to recurrence between groups, was assessed by the Kaplan–Meier method with log-rank analysis to identify any significant difference. To identify the factors that correlated with recurrence, chisquare analysis and Fisher exact tests were used where appropriate for categorical variables. For assessing continuous variables, Student t test was used. A P value of ⬍.05 was accepted as significant.
Results
Figure 2 Polypropylene all layers sutures are used for group AL (all layers).
Three hundred sixty-three patients were operated on for pilonidal sinus between November 2001 and June 2007 in our department. Of these, 67 patients refused to be included in the study. A different type of operation was performed in 44 of the patients at the discretion of the surgeon. In 14 patients, protocol violations occurred. Overall, 238 patients were included in the study. The majority of the patients
T.Z. Nursal et al. Table 1
Flap versus simple closure in pilonidal disease
173
Demographic variables, symptoms, physical findings, and stage of the disease according to the groups
Sex (male:female) Age (years, ⫾SD) BMI* Symptom Presence of pain Presence of discharge Antibiotic† Drainage‡ Recurrent cases Finding Presence of discharge Presence of hair Presence of lateral sinuses Presence of midline swelling Presence of lateral swelling Chavoin classification Stage I Stage II Stage III§ Stage IV
Group AL
Group SS
Group VYAF
P value
65:18 24.9 ⫾ 6.9 24.8 ⫾ 3.5
58:20 26.1 ⫾ 7.3 25.2 ⫾ 3.6
66:11 27.5 ⫾ 9.9 25.7 ⫾ 3.8
.207 .146 .327
54 68 36 16 8
(65.9%) (82.9%) (43.9%) (19.5%) (9.8%)
64 59 34 23 2
(83.1%) (77.6%) (44.7%) (30.3%) (2.6%)
60 66 36 14 8
(77.9%) (86.8%) (47.4%) (18.4%) (10.4%)
.034 .325 .902 .153 .127
27 39 24 5 13
(37.5%) (54.9%) (33.3%) (7.0%) (18.1%)
27 30 12 11 11
(39.1%) (42.9%) (18.2%) (17.2%) (17.5%)
31 39 28 9 18
(44.3%) (54.9%) (40.0%) (12.9%) (25.7%)
.692 .255 .019 .194 .409
4 (5.3%) 41 (54.7%) — 30 (40.0%)
.338
6 (7.6%) 44 (55.7%) — 29 (36.7%)
7 (9.2%) 50 (65.8%) — 19 (25.0%)
Note. Percentages may not add up properly as some of the data are incomplete among the variables. *BMI: body mass index (weight [kg]/height2 [m]). †Previous use of antibiotic for pilonidal disease. ‡Previous history of surgical drainage for pilonidal disease. §Acute abscess; closure is not justified; these patients are excluded.
were male (n ⫽ 189, 79.4%) and the mean age (⫾SD) was 26.2 ⫾ 8.2 years. There were 83, 78, and 77 patients in groups AL (34.9%), SS (32.8), and VYAF (32.4%), respectively. There was no difference among the groups regarding demographic variables, symptoms, ratio of recurrent cases, physical findings, and stage of the disease (Table 1). Twelve surgeons performed the operations. Surgeons who had performed fewer than 10 operations were grouped together. This data stratification process left 9 surgeons (including the group of surgeons who had performed fewer than 10 operations). Although the study group was random-
Table 2
ized, one surgeon performed exclusively primary suture methods (AL ⫽ 9 and SS ⫽ 1) (P ⫽ .008). However, according to the layered chi-square analysis, there was no difference between the type of surgery and recurrence as layered across the surgeons. Some surgical data were collected during surgery as detailed in the Methods. The results according to the groups are depicted in Table 2. Wound healing data and patient satisfaction were also recorded during the postoperative period (Table 3). Of the study group, 193 patients (81.1%) were monitored for a mean (⫾SD) duration of 29.7 ⫾ 15.6 months. Kaplan-
Surgical variables
Type of anesthesia General Spinal Local Tissue volume (mL) Defect volume (mL) Length of the defect (mm) Width of the defect (mm) Depth of the defect (mm) Tension of the wound (g) Anal distance* (mm) Duration of surgery (min) LOS (d)†
Group AL
Group SS
Group VYAF
40 (48.2%) 42 (50.6%) 1 (1.2%) 19.7 ⫾ 16.3 31.8 ⫾ 28.9 64.9 ⫾ 19.5 28.7 ⫾ 13.4 30.7 ⫾ 9.6 604.3 ⫾ 645.8 56.9 ⫾ 18.2 47.9 ⫾ 14.7 1.2 ⫾ .4
48 (62.3%) 28 (36.4%) 1 (1.3%) 26.3 ⫾ 21.9 30.5 ⫾ 21.9 64.9 ⫾ 20.2 29.6 ⫾ 13.9 31.9 ⫾ 13.5 546.9 ⫾ 368.7 51.0 ⫾ 14.2 52.7 ⫾ 19.6 1.2 ⫾ .4
42 (56.0%) 33 (44.0%) 0 (0%) 28.8 ⫾ 21.4 32.0 ⫾ 23.0 79.2 ⫾ 19.9 31.6 ⫾ 12.4 33.7 ⫾ 11.9 629.1 ⫾ 440.6 51.5 ⫾ 17.6 77.0 ⫾ 22.9 1.3 ⫾ .9
P value .301
*The distance of the lowest margin of the defect from the anus. †Hospital length of stay.
.018 .926 ⬍ .001 .416 .284 .618 .210 ⬍ .001 .250
174
The American Journal of Surgery, Vol 199, No 2, February 2010
Table 3
Postoperative results and patient satisfaction variables according to the study groups
Infection Wound dehiscence Satisfaction* Recommendation† Agree to reoperation‡ Yes No Perhaps/not sure Comfortable§ Time to start work (d) Recurrence
Group AL
Group SS
Group VYAF
P value
16 (23.9%) 8 (11.9%) 3.5 ⫾ .9 53 (86.9%)
12 (17.4%) 5 (7.4%) 3.6 ⫾ .8 56 (93.3%)
6 (10.2%) 6 (10.2%) 3.6 ⫾ .9 50 (92.6%)
.129 .665 .958 .407 .038
49 (81.7%) 9 (15.0%) 2 (3.3%) 42 (85.7%) 17.2 ⫾ 17.6 8 (12.3%)
51 (85.0%) 4 (6.7%) 5 (8.3%) 45 (86.5%) 11.5 ⫾ 10.7 7 (10.4%)
50 (94.3%) 3 (5.7%) 0 41 (82.0%) 15.1 ⫾ 16.9 10 (16.4%)
.796 .250 .595
Note. Percentages may not add up properly as some of the data are incomplete among the variables. *As graded from 0 (very dissatisfied) to 4 (very satisfied). †Recommend the same operation to an acquaintance. ‡Patients were asked if they would agree to the same operation if the need arose. §Patients were asked if they were comfortable in everyday physical activities.
Meier survival analysis was performed to assess the success of the type of surgery, ie, time to recurrence (Fig. 4). Univariate analyses were performed to identify the factors that may be correlated with recurrence (Table 4). To identify the independent variables correlated with the recurrence, logistic regression analysis was performed by entering the significant and nearly significant variables into the model. Of the entered variables, younger age, being a recurrent case, presence of discharge on physical examination, and development of surgical site infection postoperatively were found to be independent predictors of recurrence.
As expected, patients with recurrence were less likely to be satisfied with the operation. Similarly they were less eager to agree to a possible re-operation and to recommend this type of surgery to an acquaintance (Table 4).
Comments Although Mayo described a sinus with hair inside in 1833, it was Hodge, in 1880, who suggested the term pi-
Figure 4 Kaplan-Meier plot of the recurrence as stratified by the study groups. Bold black line: VYAF; bold gray line: AL; thin black line: SS groups. Log-rank analysis (Mantel–Cox); P ⫽ .648.
T.Z. Nursal et al. Table 4
Flap versus simple closure in pilonidal disease
175
Variables with possible correlation with the primary outcome (recurrence)
Sex (male:female) Age (years, ⫾SD) BMI* Symptom Presence of pain Presence of discharge Antibiotic† Drainage‡ Recurrent cases Finding Presence of discharge Presence of hair Presence of lateral sinuses Presence of midline swelling Presence of lateral swelling Chavoin classification Stage I Stage II Stage IV Type of anesthesia General Spinal Local Tissue volume (mL) Defect volume (mL) Length of the defect (mm) Width of the defect (mm) Depth of the defect (mm) Tension of the wound (g) Anal distance§ (mm) Duration of surgery (min.) LOS (d)¶ Infection Wound dehiscence Satisfaction\\ Recommendation** Agree to reoperation†† Yes No Perhaps/not sure Comfortable‡‡ Time to start work (d)
No recurrence
Recurrence
135:32 26.9 ⫾ 8.3 25.8 ⫾ 3.7
18:8 21.5 ⫾ 7.4 23.6 ⫾ 3.2
.174 .002 .008
.044 .874
41 133 76 43 11
(24.7%) (81.1%) (46.3%) (26.2%) (6.6%)
7 24 13 4 6
(26.9%) (92.3%) (50.0%) (15.4%) (23.1%)
.808 .263 .728 .234 .015
.031
55 75 41 22 25
(36.9%) (50.0%) (27.7%) (15.2%) (17.2%)
15 10 6 0 4
(71.4%) (47.6%) (28.6%)
.003 .838 .934 .079 .766 .445
15 (9.3%) 99 (61.1%) 48 (29.6%)
P (univariate)
(19.0%)
P (multivariate)
.013 .998
1 (3.8%) 19 (73.1%) 6 (23.1%) .593
93 (56.0%) 71 (42.8%) 2 (1.2%) 24.5 ⫾ 20.9 30.5 ⫾ 24.9 68.7 ⫾ 20.2 29.6 ⫾ 12.6 31.4 ⫾ 10.7 607.0 ⫾ 549.4 53.5 ⫾ 16.9 57.6 ⫾ 22.0 1.2 ⫾ .4 23 (13.8%) 18 (10.5%) 3.7 ⫾ .7 145 (94.8%)
16 (64.0%) 9 (36.0%) 0 27.1 ⫾ 17.3 44.1 ⫾ 32.5 77.4 ⫾ 21.7 31.2 ⫾ 17.8 36.7 ⫾ 11.4 658.7 ⫾ 446.1 54.4 ⫾ 17.7 59.2 ⫾ 19.5 1.5 ⫾ 1.4 8 (33.3%) 5 (26.3%) 2.3 ⫾ 1.4 14 (63.6)
138 (91.4%) 7 (4.6%) 6 (4.0%) 119 (91.5%) 15.0 ⫾ 15.7
12 (54.5%) 9 (40.9%) 1 (4.5%) 9 (42.9%) 11.5 ⫾ 14.1
.559 .025 .081 .682 .027 .674 .863 .716 .198 .032 .059 ⬍ .001 ⬍ .001 ⬍ .001
.490 .309 .376
.033 .502
⬍ .001 .404
Note. Percentages may not add up properly as some of the data are incomplete among the variables. *BMI: body mass index (weight [kg]/height2 [m]). †Previous use of antibiotic for pilonidal disease. ‡Previous history of surgical drainage for pilonidal disease. §The distance of the lowest margin of the defect from the anus. ¶Hospital length of stay. \\As graded from 0 (very dissatisfied) to 4 (very satisfied). **Recommend the same operation to an acquaintance. ††Patients were asked if they would agree to the same operation if the need arose. ‡‡Patients were asked if they were comfortable in everyday physical activities.
lonidal sinus.1 It is a common disease with a reported incidence of 26/100,000.13 Similar to our cohort, the reported mean age of patients is approximately 30 years and almost 80% are male.1 In this group (young males) the prevalence of pilonidal disease was reported to be as high as 88/1,000.2
Although previously a congenital origin was suggested for the etiology, the acquired theory is widely accepted today. The hair at the opposite site of the natal cleft and accumulated loose hair is constantly burrowed to the skin of the gluteal region with the movement of the buttocks. Ongoing irritation results in micro-abscesses, and the suction
176 movement of the gluteal region further pulls the hair in these abscesses, which further enlarge.1,3 Among the numerous treatment methods, flattening of the natal cleft has been advocated as a means of decreasing recurrence.5 Various flap procedures have been devised for this goal. One of the easier methods of flap operations is the VYAF. Experience with the VYAF method for pilonidal disease in the literature generally consists of case series.6 –9 One of these studies, although with a prospectively controlled design, only compared 2 modifications of VYAF.7 These studies reported recurrence rates ranging from 0% to 6%. To our knowledge, there is only 1 controlled study involving VYAF.14 The authors in the mentioned study compared VYAF to another flap method (Limberg flap). The Limberg flap was concluded to be the better method. However, this retrospective study has a number of limitations. First, it was not randomized. The surgeons, whose distribution among groups not mentioned, chose the type of surgery they would perform. Furthermore, patients with multiple recurrences were excluded from the study. Although the statement of the superiority of the Limberg flap might be true, the design limitations preclude definite conclusions. Primary closure is the most common method used to treat pilonidal disease.5 Success as defined by the recurrence rate varies between 0% to almost 40%. Although the technique is criticized by both the minimalist approach advocates and the more aggressive flap operators, a more recent study documenting the results of at least 5 years of follow-up reported a recurrence rate of a very acceptable 3% following midline primary closure.15 To the best of our knowledge, the present study is the first prospectively randomized controlled study comparing VYAF to another technique, ie, the simple primary closure. The groups were comparable in terms of demographics (Table 1). The uneven distribution of the 2 variables (symptom: presence of pain and presence of lateral sinuses) among the groups might have had a confounding effect to the primary outcome (recurrence). Similarly, the distribution of the surgeons was uneven among the groups. Therefore, layered chi-square analysis was performed for these variables, which revealed no difference. The resected tissue volume was smaller in the AL group and the length of the remaining defect was longer in the VYAF group. These factors were also not independent predictors of recurrence (Table 4). Being a more complex operation than the primary closure methods, VYAF, as expected, took longer to perform. Although retrospective studies and case series reported promising results, we were not able to show that VYAF is a better method than simple closure techniques. There was no statistically significant difference in the rate of early wound problems and recurrences between the groups. In this study we have included all probable patients who are eligible to have a primary closure as decided by the surgeon. In the literature, however, VYAF is generally preferred for the difficult, chronic and recurrent cases. It may be argued
The American Journal of Surgery, Vol 199, No 2, February 2010 that the focus of the study should be this difficult group. However, it is not possible to compare simple closure with VYAF in these difficult cases. Primary closure usually is not technically possible and these patients would have already been directed to another procedure rather than simple primary closure. In an eligible patient for primary closure, a method (VYAF, Limber, other flap) addressing the pathophysiology of the disease process, ie, flattening of the natal cleft without tension, may theoretically decrease complications. This idea formed the basis of our study. Nevertheless, as a subgroup, we have further analyzed our data for the chronically inflamed cases with lateral draining sinuses (Chavoin stage IV), and for recurrent cases. Although these were difficult cases, primary closure was technically deemed possible and was included in the study. In these cases there still was not any difference between groups in terms of recurrence (P ⫽ .856 and .689, respectively). One potential drawback of this study might have been the inclusion of 2 primary closure methods, which might have diluted the study power and the results. However, the necessary power analysis and sample size calculations have been performed initially. The sample size is sufficient for the mentioned parameters. A limitation of the present study is the use of nonstandard methods to assess the quality of life. Although our assessment may not be as sensitive as a generic form such as the SF-36, it is simple and quickly done. With our method, we could not show any significant difference between groups regarding the quality of life. Another aspect of this study was to delineate any independent factors that would predict recurrence. For this, we have recorded many variables, including the dynamic mechanical properties of the defect (Table 4). Although a number of factors were correlated with recurrence, only younger age, recurrent cases, and finding of discharge in the physical examination were independent predictors of recurrence among the preoperative factors. A new classification system was proposed recently that takes into account the previous history of pilonidal disease, ie, recurrence.16 This classification might better predict the prognosis for pilonidal disease surgery as we have shown that previous recurrence is an independent predictor of recurrence. Presence of infection is a common problem that prolongs the convalescence period and delays the return to full activity.5 However as shown by our data, its importance lies not only in the early postoperative period. Development of surgical site infection is the only variable correlated with recurrence among the postoperative factors. Therefore, strict adherence to preventive measures for infection control should be exercised in pilonidal sinus surgery.
Conclusions Patients who are admitted with pilonidal disease should be informed of an increased risk of recurrence if they have
T.Z. Nursal et al.
Flap versus simple closure in pilonidal disease
a recurrent disease, draining sinuses, and infection develops following the operation. Although theoretically appealing, the VYAF technique does not offer any advantages compared to the simpler primary closure techniques. VYAF technique, however, may be needed especially in patients with large defects that cannot be mechanically approximated with primary closure. On the other hand, as this is the only prospectively randomized controlled study, further properly designed studies comparing VYAF to other methods are needed.
References 1. Chintapatla S, Safarani N, Kumar S, et al. Sacrococcygeal pilonidal sinus: historical review, pathological insight and surgical options. Tech Coloproctol 2003;7:3– 8. 2. Akinci OF, Bozer M, Uzunkoy A, et al. Incidence and aetiological factors in pilonidal sinus among Turkish soldiers. Eur J Surg 1999; 165:339 – 42. 3. Schoeller T, Wechselberger G, Otto A, et al. Definite surgical treatment of complicated recurrent pilonidal disease with a modified fasciocutaneous V–Y advancement flap. Surgery 1997;121:258 – 63. 4. McCallum IJ, King PM, Bruce J. Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and metal-analysis. BMJ 2008;19:868 –71. 5. Petersen S, Koch R, Stelzner S, et al. Primary closure techniques in chronic pilonidal sinus: a survey of the results of different surgical approaches. Dis Colon Rectum 2002;45:1458 – 67.
177
6. Khatri VP, Espinosa MH, Amin AK. Management of recurrent pilonidal sinus by simple V–Y fasciocutaneous flap. Dis Colon Rectum 1994;37:1232–5. 7. Berkem H, Topaloglu S, Ozel H, et al. V–Y advancement flap closures for complicated pilonidal sinus disease. Int J Colorectal Dis 2005;20: 343– 8. 8. Dilek ON, Bekereciog˘lu M. Role of simple advancement flap in the treatment of complicated pilonidal sinus. Eur J Surg 1998;164:961– 4. 9. Saray A, Dirlik M, Caglikulekci M, et al. Advancement fasciocutaneous flap for treatment of chronic pilonidal sinus disease. Scand J Plast Reconstr Surg Hand Surg 2002;36:80 – 4. 10. Quinodoz PD, Chilcott M, Grolleau JL, et al. Surgical treatment of sacrococcygeal pilonidal sinus disease by excision and skin flaps: the Toulouse experience. Eur J Surg 1999;165:1061–5. 11. Dupont WD, Plummer WD. PS power and sample size program available for free on the Internet. Control Clin Trials 1997;18:274. 12. Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20: 250 –78. 13. Søndenaa K, Andersen E, Nesvik I, et al. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis 1995;10:39 – 42. 14. Unalp HR, Derici H, Kamer E, et al. Lower recurrence rate for Limberg v flap for pilonidal sinus. Dis Colon Rectum 2007;50: 1436 – 44. 15. Tocchi A, Mazzoni G, Bononi M, et al. Outcome of chronic pilonidal disease treatment after ambulatory plain midline excision and primary suture. Am J Surg 2008;196:28 –33. 16. Tezel E. A new classification according to navicular area concept for sacrococcygeal pilonidal disease. Colorectal Dis 2007;9: 575– 6.