- Email: [email protected]
A randomized study between excision and marsupialization and radiofrequency sinus excision in sacro-coccygeal pilonidal disease
ORIGINAL REPORTS
A Randomized Study Between Excision and Marsupialization and Radiofrequency Sinus Excision in Sacro-coccygeal Pilonidal Disease Pravin J. Gupta, MS (General Surgery) Gupta Nursing Home, Nagpur, India BACKGROUND: The surgical approach to pilonidal sinus
disease is open to debate. This prospective, randomized study was aimed to compare the outcome of the excision and marsupialization and the sinus excision technique by radiofrequency. MATERIALS AND METHODS: Thirty patients of chronic pilonidal sinus disease were randomly assigned to radiofrequency sinus excision (n ⫽ 15) and excision and marsupialization (n ⫽ 15). The parameters measured included intraoperative and postoperative data, wound-related complications, and recurrence. Patient satisfaction score was assessed at 1-year follow-up. RESULTS: The operation time, postoperative pain, hospital
stay, and off work periods were significantly less (p ⬍ 0.05) in the technique employing radiofrequency surgery. At 1-year follow-up, there was 1 case of recurrence in each group. The patients from radiofrequency group expressed better satisfaction than the patients operated by marsupialization.
CONCLUSION: Radiofrequency sinus excision technique
needs a shorter hospital stay with reduced postoperative pain and early resumption to work in comparison with the sinus excision and marsupialization technique. (Curr Surg 61: 307-312. © 2004 by the Association of Program Directors in Surgery.) KEY WORDS: pilonidal sinus, excision and marsupialization,
radiofrequency surgery, recurrence
INTRODUCTION A sacro-coccygeal pilonidal sinus consists of a sinus or fistula situated at a short distance behind the anus and generally contains hairs. The treatment options range from a conservative approach1 to an extensive surgical excision. However, none of these is free of the complications like delayed wound healing, infection, and recurrence. Correspondence: Inquiries to Pravin J. Gupta, MS, Gupta Nursing Home, D/9, Laxminagar, Nagpur-440022, India; fax: (91) 712-254-7837; e-mail: [email protected]
Sinus excision is a commonly practiced procedure for pilonidal disease, wherein the sinus tracts are excised along with the surrounding tissue up to the presacral fascia. The matter of debate lies with the mode and manner of reconstruction of the large wound left behind. A wide excision of the sinus tract takes a long wound healing time and a need for regular dressing and meticulous wound care. Although excision with primary closure obviates a large wound, the chances of wound infection, wound dehiscence, and recurrence are very high.2 Complex procedures like closure by Z-plasty, rhomboid, or myocutaneous advancement flaps have all been proposed to reduce the recurrence rate. Nevertheless, these techniques involve long operating time and hospital stay, and still the incidences of complication like loss of the graft or flap are no less.3 The asymmetric-oblique closure technique or flap technique have been found to provide better results than the simple closure in the natal midline (natal cleft).4 Another technique used is marsupialization, in which partial closure of the wound is achieved by approximation of the skin edges after radical excision. The advocates of this technique claim that this reduces hospital stay, postoperative complications, and recurrence rate.5 Minimally Invasive Technique Karydakis described a minimally invasive technique that included the removal of the midline sinuses and lateral tracts.6 It is simple to perform, and the complication and recurrence rates are within the acceptable limits. Even better results can be achieved when the above procedure is performed using a radiofrequency device. We present this study describing the technique of radiofrequency sinus excision and a comparative analysis with the excision and marsupialization technique.
MATERIALS AND METHODS The study was carried out at Gupta Nursing Home, Nagpur, India, between July 2000 and June 2001. Thirty patients with limited, chronic pilonidal disease were randomized into 2
CURRENT SURGERY • © 2004 by the Association of Program Directors in Surgery Published by Elsevier Inc.
0149-7944/04/$30.00 doi:10.1016/j.cursur.2003.11.015
307
groups, group A and group B. Group A patients were operated by the excision and marsupialization technique,7,8 whereas patients from group B were operated by sinus excision technique in which the entire sinus tract was removed with the help of radiofrequency device. Randomization was done by sealed envelope, which was opened by the hospital nurse. Patients having acute disease, those who had been previously operated for this pathology, and those having more than 4 visible sinuses on clinical examination were excluded from the study. There were 16 males and 14 females with a mean age of 24 years (range, 16-32). As the procedure of marsupialization required an operation time of more than 30 minutes, we preferred to operate the patients from group A under spinal anesthesia, and those from group B were operated under a short general anesthesia because of a brief operating time of about 12 minutes. The same surgeon performed all of the operations. The study was approved by the local ethical committee and was performed according to the declaration of Helsinki. An informed consent was obtained from all patients. Radiofrequency Surgery Radiofrequency surgery is a method of achieving simultaneous cutting and coagulation of the tissues. The effect of cutting, known as high-frequency section, is executed without pressuring or crushing the tissue cells. This is made possible because of the heat produced by the resistance offered by the tissues to the passage of the high-frequency wave. We used a radio surgical generator Ellman dual-frequency 4 MHz (Ellman International, Hewlett, New York) for this study. This instrument produces an electromagnetic wave of a very high frequency of 4 MHz. The unit is supplied with a handle to which different interchangeable electrodes could be attached to suit the requirement. A fine-needle electrode to open up the sinus tracts, a ball electrode for coagulation, and a round loop electrode for shaving the offending tissue were used in this procedure.9
FIGURE 1. Excision and marsupialization of the pilonidal sinus tracts.
tract and its branches.10 A probe was then inserted in the sinus opening, and with the help of the fine-needle electrode, the skin and subcutaneous tissue were incised leaving an area of at least 1 cm around the sinus opening. Any brisk bleeding encountered was secured by coagulating it with the ball electrode. A funnel-shaped dissection continued until the inner end of the sinus tract was reached. No attempt was made to deepen the incision to the postsacral fascia. If the sinuses were found connected with each other, the fistula tract and the skin between the 2 sinuses were simultaneously excised. All of the tracts were traced in the similar manner, and the offending blue colored tissue was shaved off with the round loop electrode, leaving behind a red, raw area. Care was taken that the wound should acquire a shape of an inverted cone, ie, widest externally and narrowest internally. To end with, the wound was covered with an adhesive dressing. Patients from group B were discharged on the same day of
Incision and Marsupialization Technique The sinus tracts were opened in the midline, and the resultant complex cavity was excised. The granulation tissue was curetted. The skin edge and the fibrous tissues in the depth were then sutured together with 2-0 absorbable sutures in a continuous and locking fashion (Fig.1). Radiofrequency Sinus Excision Procedure The procedure was performed keeping the patient in left lateral position (see Figs. 2 to 4). The sinus openings were identified and marked with an indelible pen after preparing the operating area with povidone iodine. Methylene blue mixed with hydrogen peroxide was instilled into one of the sinuses. Addition of hydrogen peroxide helped in opening up the tracts and gave a clear guideline about the 308
FIGURE 2. Sinus excision technique using radiofrequency. A funnelshaped excision is made to remove the entire sinus tract with minimum of surrounding healthy tissue. CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
FIGURE 5. Completely healed wound.
Treatment Evaluation
FIGURE 3. Sinus tract excision using radiofrequency for 2 or more interconnecting sinuses. The fistula tract along with overlying skin is removed.
the procedure, whereas those from group A were discharged on the next day of operation. Postoperative Care Patients were asked to clean the wound regularly with soap and to cover the wound with protective dressing. A course of antiinflammatory analgesics (Diclofenac Sodium 50 mg twice daily) was given for first 5 days and then as and when they felt pain. No antibiotic was prescribed. The patients from both the groups were called every week to keep a watch on the healing process of the wound, complications like infection, delayed wound healing, premature approximation of the edges, and so on. This follow-up was continued until the wound healed completely. Thereafter, the patients were asked to report after 12 months of the procedure (Fig. 5).
FIGURE 4. Sinus tract excision using radiofrequency for 4 interconnecting sinuses. The fistula tract along with overlying skin is removed. CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
Both of the groups were evaluated in terms of demographics, symptoms prior to the procedure, operation time, postoperative complications, healing period, and recurrence. After discharge, the pain was recorded by the patient using a 4-point verbal rating scale (0, no pain; 3, most severe pain) in a diary given to all of the patients. The diary was returned on follow-up at 15th postoperative day, and an independent observer blinded to the type of procedure made the assessment of pain. At a personal follow-up of at least 12 months, an independent observer asked the patients to rank the overall satisfaction with the procedure carried out using a visual analogue scale (0 ⫽ dissatisfied, 10 ⫽ satisfied). Statistical Analysis The results were presented as median and range. Data were entered in to a database and analyzed using statistical software (Graph pad Software, San Diego, California). The chi-square test and the unpaired Student t-test were used for evaluation; and a p value of less than 0.05 was considered significant.
RESULTS A total of 30 patients with limited, chronic pilonidal disease were randomly assigned to receive excision and marsupialization technique (group A) or sinus excision technique by radiofrequency (group B) (Table 1). The patient demographics and symptoms prior to procedure were similar in both of the groups. Intermittent discharge and pain were the most common symptoms. The operative time was calculated from giving the incision to completion of the procedure, ie, application of dressing. The procedure time was significantly shorter in radiofrequency group than the marsupialization group (11 versus 37 minutes). Group A patients required a longer hospitalization period (32 versus 9 hours) as compared with group B patients. None of the patients from the 2 groups encountered any immediate postoperative complication like bleeding from the wound or anesthesia related problems (see Table 2). 309
TABLE 1. Patient Demographic and Pretreatment Symptoms Excision and marsupialization [n ⴝ 14]
Radiofrequency sinus excision [n ⴝ 14]
23 (16-32) 7:8 13 11 7 2
25 (17-30) 9:6 14 12 6 1
Age (years)* Male: Female Discharge Pain Pruritus Bleeding
thereof remains controversial. However, a consensus has reached that an ideal therapy for treatment of pilonidal disease should be simple, should inflict minimal pain, and should need a short hospital stay.11 It should allow early return to work, requiring minimal wound care and with a low rate of recurrence. The sinus excision technique using radiofrequency is found to meet most of these criteria. It is observed that simpler treatment methods of pilonidal disease not only carry less morbidity, but they are also associated with lower recurrence rate.12-14
* Values are mean (range).
The period of postoperative pain in patients from group A was longer when compared with their counterparts in group B (12 versus 4 days). Consequently, the patients from group A needed almost double the doses of analgesics in comparison with the patients in group B operated by radiofrequency technique. Patients from group B resumed their routine activities earlier in comparison with patients from group A (6 versus 17 days). Two patients from the marsupialization group developed wound infection in the form of suppuration in the suture line between the 10th and 15th day of the procedure. The wounds were thoroughly cleaned, and patients were prescribed antibiotics for next 10 days. An uneventful wound healing was accomplished thereafter. Such complication was not reported by patients of group B. The follow-up period was similar in both of the groups. The wounds of patients from group A healed earlier than in the patients from group B, although the difference was not significant. At a follow-up after 12 months, 1 patient from each group developed recurrence. The mean satisfaction grading was 9.2 in radiofrequency group in comparison with 7.8 in marsupialization group (Table 3).
DISCUSSION Although the history of surgical therapy of pilonidal disease now dates back to more than a century, the management
Time Taken for the Procedure The operation period in the radiofrequency sinus excision was significantly shorter as compared with the marsupialization technique. This was possible because while cutting, the electrodes provide a coagulation effect,15 obviating the need to secure the bleeding points. As there is no need to suture the edges like in marsupialization, the time spent in this maneuver is reduced. Need of Suture Material Although for marsupialization suture material is needed to approximate the edges of the wound, sinus excision with radiofrequency does not need any suture material. This helps in minimizing the potential complication of sepsis or wound dehiscence observed with suturing of the wound.16 Postoperative Pain The cause of postsurgical pain is because of either exposure of the sensory nerve endings or by an inflammatory response causing local edema because of lymphatic permeability. Radiofrequency surgery has been found to seal the sensory nerve endings and the leaking lymphatics,17 causing an appreciable fall in the postoperative pain. With the reduced intensity and duration of pain, the patients needed fewer doses of analgesics than their counter parts. In contrast, the marsupialization procedure requires approx-
TABLE 2. Postoperative Results Excision and marsupialization [n ⴝ 14] [Group A] Operation time in minutes. Hospitalization in hrs. Period off work in days. Period of postoperative pain in days. Wound infection (n) Follow up in months Healing period (days) Recurrence (n)
36 33.5 16.5 11.5
(34-38) (30-36) (12-19) (9-14) 2 13 (12-14) 44.5 (34-47) 1
Radiofrequency sinus excision [n ⴝ 14] [Group B] 11.5 9.5 6 4.5
(10-17) (6-11) (4-8) (2-8) 0 14 (12-15) 41.5 (38-58) 1
P 0.002 0.03 0.02 0.04 NS NS NS NS
Values are median [range] NS - not significant. 310
CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
TABLE 3. Patients Satisfaction Grading Excision and marsupialization group
Radiofrequency sinus excision group
7.8 [7.3-8.1]
9.2 [8.9-9.4]
Mean score [Range]
Values are median [range]. (Visual analogue scale 0 ⫽ Dissatisfied. 10 ⫽ satisfied).
imation of wound leading to tension and subsequent pain and discomfort.18 Hospital Stay Although the patients operated with radiofrequency procedure were discharged within 12 hours of the procedure, the average duration of hospital stay was 33 hours in patients operated by marsupialization.19,20 The reason for this was because of the type of anesthesia, postoperative pain, and discomfort. Period Off Work The patients operated by radiofrequency technique were able to join their duties much earlier than the patients operated by marsupialization method. This was possible because of the reduced pain, and minimal discomfort in body movements21. The patients from the radiofrequency group were found more comfortable with movements like sitting, walking, and performing routine activities than their counterparts, which encouraged them to resume duties early. Shafik has described use of electrocauterization in the treatment of pilonidal sinus.22 However, this technique invariably results in damage to the adjacent healthy tissues further, causing more pain and delay in wound healing.23 Nd: YAG24 and Ruby lasers25 have been used in treating pilonidal disease and are reported to reduce pain, length of hospitalization, and early return to work. Although the radiofrequency instrument has almost all of the advantages of laser, it is free from disadvantages like the risk of misdirected reflected beams, the prolonged healing period involved, and the high cost of treatment with lasers.26 Another advantage of radio surgery is that malleable electrodes are available that could be selected to suit the exacting requirements of any surgical position. This is especially found of great help when working on a cavity of the pilonidal sinus with the presence of offending tissues.9 A follow-up of 1 year was found sufficient for the study. “Recurrences” occurring a year or more after surgery are usually because of formation of new sinuses and should be dealt with accordingly.27 Radiofrequency device allows cutting and coagulation of tissues in an atraumatic manner, contrary to the electric bistoury. The advantages of radiofrequency over electrocautery and laser energy surgery reside in its precision in ablating tissues and in its control of operation. With radiofrequency, the targeted tissue CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
temperatures stay localized within a 60 to 90°C range, thus limiting heat dissipation and damage to adjacent tissue.21 In contrast, electrocautery, diathermy, and laser temperatures are significantly higher (750 to 900°C), which result in significant heat propagation in excess of the desired therapeutic need. These differences allow for radiofrequency being found more accurate, minimally invasive, and less morbid without compromising the treatment efficacy and durability.23 Although techniques using conventional scalpel apparently works in an atraumatic way, the prominence of bleeding from the wound forces the surgeon to coagulate the bleeders with traditional electrocautery or diathermy more frequently than radiofrequency. The radio waves can seal the small blood vessels without creating any char, whereas the cautery or elcetrosurgical instruments create heat at the tip of the instruments to seal the affected portion with transferred heat, and in the process invariably damage the adjacent healthy tissues, which consequently cause more edema and postoperative pain.28 The patients treated with sinus excision technique by radiofrequency expressed greater satisfaction in comparison with the marsupialization group. This is explainable on the overall comfort ratio. The patients needed brief hospital stay and shorter period off work. With minimal postoperative pain, negligible wound complication and ease in the bodily movements, they found radiofrequency technique much more comfortable.
CONCLUSION An ideal treatment for chronic pilonidal disease would be the one that minimizes hospital stay, ensures early wound healing, avoids risk of complications, minimizes the rate of recurrence and involves minimal time off the work. The sinus excision technique by radiofrequency seems to fulfill most of these criteria. The patient satisfaction is perceptibly greater than that in the excision and marsupialization procedure. The study results do indicate that the sinus excision technique by radiofrequency could be an alternative option in the treatment of limited, chronic pilonidal disease.
REFERENCES 1. Armstrong JH, Barcia PJ. Pilonidal sinus disease. The con-
servative approach. Arch.Surg. 1994;129:914-917. 2. Lee HC, Ho YH, Seow CF, Eu KW, Nyam D. Pilonidal
disease in Singapore: clinical features and management. Aust N Z J Surg. 2000;70:196-198. 3. Zieger K. Complications after surgery for pilonidal cyst.
An introduction to a new debate on a “costly” disease. Ugeskr Laeger. 1999;161:6056-6058. 4. Petersen S, Koch R, Stelzner S, Wendlandt TP, Ludwig K.
Primary closure techniques in chronic pilonidal sinus: a survey of the results of different surgical approaches. Dis Colon Rectum. 2002;45:1458-1467. 311
5. Spivak H, Brooks VL, Nussbaum M, Friedman I. Treat-
18. Menzel T, Dorner A, Cramer J. Excision and open wound
ment of chronic pilonidal disease. Dis Colon Rectum. 1996; 39:1136-1139.
treatment of pilonidal sinus. Rate of recurrence and duration of work incapacity. Dtsch Med Wochenschr. 1997; 122:1447-1451.
6. Karydakis GE. New approach to the problem of pilonidal
sinus. Lancet. 1973;2:1414-1415. 7. Meban S, Hunter E. Outpatient treatment of pilonidal
disease. Can Med Assoc J. 1982;126:941. 8. Duchateau J, De Mol J, Bostoen H, Allegaert W. Pilonidal
19. Aydede H, Erhan Y, Sakarya A, Kumkumoglu Y. Com-
parison of three methods in surgical treatment of pilonidal disease. Aust N Z J Surg. 2001;71:362-364. 20. Ortiz HH, Marti J, Sitges A. Pilonidal sinus: a claim for
sinus. Excision—marsupialization—phenolization? Acta Chir Belg. 1985;85:325-328.
simple track incision. Dis Colon Rectum. 1977;20:325328.
9. Goldberg SN, Gazelle GS, Dawson SL, et al. Tissue abla-
21. Brown JS. Radiosurgery. In: Minor Surgery. A Text and
tion with radiofrequency: effect of probe size, gauge, duration and temperature on lesion volume. Acad Radiol. 1995;2:399-404. 10. Gunawardhana PA, Deen KI. Comparison of hydrogen
peroxide instillation with Goodsall’s rule for fistula-inano. ANZ J Surg. 2001;71:472-474. 11. Hull TL, Wu J. Pilonidal disease. Surg Clin North Am.
2002;82:1169-1185. 12. Hurst DW. The evolution of management of pilonidal
sinus disease. Can J Surg. 1984;27:603-605. 13. da Silva JH. Pilonidal cyst: cause and treatment. Dis Colon
Rectum. 2000;43:1146-1156. 14. Isbister WH, Prasad J. Pilonidal disease. Aust N Z J Surg.
1995;65:561-563. 15. Niamtu J. Oral and Maxillofacial surgical clinics of North
America. Cosmetic Facial Surg. 2000;12:771-780.
Atlas. London: Arnold; 1994:312. 22. Shafik A. Electrocauterization in the treatment of pi-
lonidal sinus. Int Surg. 1996;81:83-84. 23. Saidi MH, Setzler KR, Farhart SA, Akright BD. Compar-
ison of office loop electrosurgical conization and cold knife conization. J Am Assoc Gynecol Laparosc. 1994;1: 135-139. 24. Palesty JA, Zahir KS, Dudrick SJ, Ferri S, Tripodi G. Nd:
YAG laser surgery for the excision of pilonidal cysts: a comparison with traditional techniques. Lasers Surg Med. 2000;26:380-385. 25. Lavelle M, Jafri Z, Town G. Recurrent pilonidal sinus
treated with epilation using a ruby laser. J Cosmet Laser Ther. 2002;4:45-47. 26. Hofmann A, Wustner M, Ciric B. Radiowave surgery case
report. Int J Aest Rest Surg. 1996;4:131-133.
16. Miocinovic M, Horzic M, Bunoza D. The treatment of
27. Miller DM. Pilonidal sinus. In: Thomson JPS, Nicholls
pilonidal disease of the sacrococcygeal region by the method of limited excision and open wound healing. Acta Med Croatica. 2000;54:27-31.
RJ, Williams CB, eds. Colorectal disease. London: William Heinemann Medical Books Limited; 1981:360.
17. Hussain SA, Hussain S. Incisions with knife or diathermy
and postoperative pain. Br J Surg. 1988;75:1179-1180.
312
28. Pfenninger JL, DeWitt DE. Radiofrequency surgery. In:
Pfenninger JL, Fowler GC, eds. Procedures for primary care physicians. St. Louis: Mosby; 1991:91-101.
CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
A Randomized Study Between Excision and Marsupialization and Radiofrequency Sinus Excision in Sacro-coccygeal Pilonidal Disease Pravin J. Gupta, MS (General Surgery) Gupta Nursing Home, Nagpur, India BACKGROUND: The surgical approach to pilonidal sinus
disease is open to debate. This prospective, randomized study was aimed to compare the outcome of the excision and marsupialization and the sinus excision technique by radiofrequency. MATERIALS AND METHODS: Thirty patients of chronic pilonidal sinus disease were randomly assigned to radiofrequency sinus excision (n ⫽ 15) and excision and marsupialization (n ⫽ 15). The parameters measured included intraoperative and postoperative data, wound-related complications, and recurrence. Patient satisfaction score was assessed at 1-year follow-up. RESULTS: The operation time, postoperative pain, hospital
stay, and off work periods were significantly less (p ⬍ 0.05) in the technique employing radiofrequency surgery. At 1-year follow-up, there was 1 case of recurrence in each group. The patients from radiofrequency group expressed better satisfaction than the patients operated by marsupialization.
CONCLUSION: Radiofrequency sinus excision technique
needs a shorter hospital stay with reduced postoperative pain and early resumption to work in comparison with the sinus excision and marsupialization technique. (Curr Surg 61: 307-312. © 2004 by the Association of Program Directors in Surgery.) KEY WORDS: pilonidal sinus, excision and marsupialization,
radiofrequency surgery, recurrence
INTRODUCTION A sacro-coccygeal pilonidal sinus consists of a sinus or fistula situated at a short distance behind the anus and generally contains hairs. The treatment options range from a conservative approach1 to an extensive surgical excision. However, none of these is free of the complications like delayed wound healing, infection, and recurrence. Correspondence: Inquiries to Pravin J. Gupta, MS, Gupta Nursing Home, D/9, Laxminagar, Nagpur-440022, India; fax: (91) 712-254-7837; e-mail: [email protected]
Sinus excision is a commonly practiced procedure for pilonidal disease, wherein the sinus tracts are excised along with the surrounding tissue up to the presacral fascia. The matter of debate lies with the mode and manner of reconstruction of the large wound left behind. A wide excision of the sinus tract takes a long wound healing time and a need for regular dressing and meticulous wound care. Although excision with primary closure obviates a large wound, the chances of wound infection, wound dehiscence, and recurrence are very high.2 Complex procedures like closure by Z-plasty, rhomboid, or myocutaneous advancement flaps have all been proposed to reduce the recurrence rate. Nevertheless, these techniques involve long operating time and hospital stay, and still the incidences of complication like loss of the graft or flap are no less.3 The asymmetric-oblique closure technique or flap technique have been found to provide better results than the simple closure in the natal midline (natal cleft).4 Another technique used is marsupialization, in which partial closure of the wound is achieved by approximation of the skin edges after radical excision. The advocates of this technique claim that this reduces hospital stay, postoperative complications, and recurrence rate.5 Minimally Invasive Technique Karydakis described a minimally invasive technique that included the removal of the midline sinuses and lateral tracts.6 It is simple to perform, and the complication and recurrence rates are within the acceptable limits. Even better results can be achieved when the above procedure is performed using a radiofrequency device. We present this study describing the technique of radiofrequency sinus excision and a comparative analysis with the excision and marsupialization technique.
MATERIALS AND METHODS The study was carried out at Gupta Nursing Home, Nagpur, India, between July 2000 and June 2001. Thirty patients with limited, chronic pilonidal disease were randomized into 2
CURRENT SURGERY • © 2004 by the Association of Program Directors in Surgery Published by Elsevier Inc.
0149-7944/04/$30.00 doi:10.1016/j.cursur.2003.11.015
307
groups, group A and group B. Group A patients were operated by the excision and marsupialization technique,7,8 whereas patients from group B were operated by sinus excision technique in which the entire sinus tract was removed with the help of radiofrequency device. Randomization was done by sealed envelope, which was opened by the hospital nurse. Patients having acute disease, those who had been previously operated for this pathology, and those having more than 4 visible sinuses on clinical examination were excluded from the study. There were 16 males and 14 females with a mean age of 24 years (range, 16-32). As the procedure of marsupialization required an operation time of more than 30 minutes, we preferred to operate the patients from group A under spinal anesthesia, and those from group B were operated under a short general anesthesia because of a brief operating time of about 12 minutes. The same surgeon performed all of the operations. The study was approved by the local ethical committee and was performed according to the declaration of Helsinki. An informed consent was obtained from all patients. Radiofrequency Surgery Radiofrequency surgery is a method of achieving simultaneous cutting and coagulation of the tissues. The effect of cutting, known as high-frequency section, is executed without pressuring or crushing the tissue cells. This is made possible because of the heat produced by the resistance offered by the tissues to the passage of the high-frequency wave. We used a radio surgical generator Ellman dual-frequency 4 MHz (Ellman International, Hewlett, New York) for this study. This instrument produces an electromagnetic wave of a very high frequency of 4 MHz. The unit is supplied with a handle to which different interchangeable electrodes could be attached to suit the requirement. A fine-needle electrode to open up the sinus tracts, a ball electrode for coagulation, and a round loop electrode for shaving the offending tissue were used in this procedure.9
FIGURE 1. Excision and marsupialization of the pilonidal sinus tracts.
tract and its branches.10 A probe was then inserted in the sinus opening, and with the help of the fine-needle electrode, the skin and subcutaneous tissue were incised leaving an area of at least 1 cm around the sinus opening. Any brisk bleeding encountered was secured by coagulating it with the ball electrode. A funnel-shaped dissection continued until the inner end of the sinus tract was reached. No attempt was made to deepen the incision to the postsacral fascia. If the sinuses were found connected with each other, the fistula tract and the skin between the 2 sinuses were simultaneously excised. All of the tracts were traced in the similar manner, and the offending blue colored tissue was shaved off with the round loop electrode, leaving behind a red, raw area. Care was taken that the wound should acquire a shape of an inverted cone, ie, widest externally and narrowest internally. To end with, the wound was covered with an adhesive dressing. Patients from group B were discharged on the same day of
Incision and Marsupialization Technique The sinus tracts were opened in the midline, and the resultant complex cavity was excised. The granulation tissue was curetted. The skin edge and the fibrous tissues in the depth were then sutured together with 2-0 absorbable sutures in a continuous and locking fashion (Fig.1). Radiofrequency Sinus Excision Procedure The procedure was performed keeping the patient in left lateral position (see Figs. 2 to 4). The sinus openings were identified and marked with an indelible pen after preparing the operating area with povidone iodine. Methylene blue mixed with hydrogen peroxide was instilled into one of the sinuses. Addition of hydrogen peroxide helped in opening up the tracts and gave a clear guideline about the 308
FIGURE 2. Sinus excision technique using radiofrequency. A funnelshaped excision is made to remove the entire sinus tract with minimum of surrounding healthy tissue. CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
FIGURE 5. Completely healed wound.
Treatment Evaluation
FIGURE 3. Sinus tract excision using radiofrequency for 2 or more interconnecting sinuses. The fistula tract along with overlying skin is removed.
the procedure, whereas those from group A were discharged on the next day of operation. Postoperative Care Patients were asked to clean the wound regularly with soap and to cover the wound with protective dressing. A course of antiinflammatory analgesics (Diclofenac Sodium 50 mg twice daily) was given for first 5 days and then as and when they felt pain. No antibiotic was prescribed. The patients from both the groups were called every week to keep a watch on the healing process of the wound, complications like infection, delayed wound healing, premature approximation of the edges, and so on. This follow-up was continued until the wound healed completely. Thereafter, the patients were asked to report after 12 months of the procedure (Fig. 5).
FIGURE 4. Sinus tract excision using radiofrequency for 4 interconnecting sinuses. The fistula tract along with overlying skin is removed. CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
Both of the groups were evaluated in terms of demographics, symptoms prior to the procedure, operation time, postoperative complications, healing period, and recurrence. After discharge, the pain was recorded by the patient using a 4-point verbal rating scale (0, no pain; 3, most severe pain) in a diary given to all of the patients. The diary was returned on follow-up at 15th postoperative day, and an independent observer blinded to the type of procedure made the assessment of pain. At a personal follow-up of at least 12 months, an independent observer asked the patients to rank the overall satisfaction with the procedure carried out using a visual analogue scale (0 ⫽ dissatisfied, 10 ⫽ satisfied). Statistical Analysis The results were presented as median and range. Data were entered in to a database and analyzed using statistical software (Graph pad Software, San Diego, California). The chi-square test and the unpaired Student t-test were used for evaluation; and a p value of less than 0.05 was considered significant.
RESULTS A total of 30 patients with limited, chronic pilonidal disease were randomly assigned to receive excision and marsupialization technique (group A) or sinus excision technique by radiofrequency (group B) (Table 1). The patient demographics and symptoms prior to procedure were similar in both of the groups. Intermittent discharge and pain were the most common symptoms. The operative time was calculated from giving the incision to completion of the procedure, ie, application of dressing. The procedure time was significantly shorter in radiofrequency group than the marsupialization group (11 versus 37 minutes). Group A patients required a longer hospitalization period (32 versus 9 hours) as compared with group B patients. None of the patients from the 2 groups encountered any immediate postoperative complication like bleeding from the wound or anesthesia related problems (see Table 2). 309
TABLE 1. Patient Demographic and Pretreatment Symptoms Excision and marsupialization [n ⴝ 14]
Radiofrequency sinus excision [n ⴝ 14]
23 (16-32) 7:8 13 11 7 2
25 (17-30) 9:6 14 12 6 1
Age (years)* Male: Female Discharge Pain Pruritus Bleeding
thereof remains controversial. However, a consensus has reached that an ideal therapy for treatment of pilonidal disease should be simple, should inflict minimal pain, and should need a short hospital stay.11 It should allow early return to work, requiring minimal wound care and with a low rate of recurrence. The sinus excision technique using radiofrequency is found to meet most of these criteria. It is observed that simpler treatment methods of pilonidal disease not only carry less morbidity, but they are also associated with lower recurrence rate.12-14
* Values are mean (range).
The period of postoperative pain in patients from group A was longer when compared with their counterparts in group B (12 versus 4 days). Consequently, the patients from group A needed almost double the doses of analgesics in comparison with the patients in group B operated by radiofrequency technique. Patients from group B resumed their routine activities earlier in comparison with patients from group A (6 versus 17 days). Two patients from the marsupialization group developed wound infection in the form of suppuration in the suture line between the 10th and 15th day of the procedure. The wounds were thoroughly cleaned, and patients were prescribed antibiotics for next 10 days. An uneventful wound healing was accomplished thereafter. Such complication was not reported by patients of group B. The follow-up period was similar in both of the groups. The wounds of patients from group A healed earlier than in the patients from group B, although the difference was not significant. At a follow-up after 12 months, 1 patient from each group developed recurrence. The mean satisfaction grading was 9.2 in radiofrequency group in comparison with 7.8 in marsupialization group (Table 3).
DISCUSSION Although the history of surgical therapy of pilonidal disease now dates back to more than a century, the management
Time Taken for the Procedure The operation period in the radiofrequency sinus excision was significantly shorter as compared with the marsupialization technique. This was possible because while cutting, the electrodes provide a coagulation effect,15 obviating the need to secure the bleeding points. As there is no need to suture the edges like in marsupialization, the time spent in this maneuver is reduced. Need of Suture Material Although for marsupialization suture material is needed to approximate the edges of the wound, sinus excision with radiofrequency does not need any suture material. This helps in minimizing the potential complication of sepsis or wound dehiscence observed with suturing of the wound.16 Postoperative Pain The cause of postsurgical pain is because of either exposure of the sensory nerve endings or by an inflammatory response causing local edema because of lymphatic permeability. Radiofrequency surgery has been found to seal the sensory nerve endings and the leaking lymphatics,17 causing an appreciable fall in the postoperative pain. With the reduced intensity and duration of pain, the patients needed fewer doses of analgesics than their counter parts. In contrast, the marsupialization procedure requires approx-
TABLE 2. Postoperative Results Excision and marsupialization [n ⴝ 14] [Group A] Operation time in minutes. Hospitalization in hrs. Period off work in days. Period of postoperative pain in days. Wound infection (n) Follow up in months Healing period (days) Recurrence (n)
36 33.5 16.5 11.5
(34-38) (30-36) (12-19) (9-14) 2 13 (12-14) 44.5 (34-47) 1
Radiofrequency sinus excision [n ⴝ 14] [Group B] 11.5 9.5 6 4.5
(10-17) (6-11) (4-8) (2-8) 0 14 (12-15) 41.5 (38-58) 1
P 0.002 0.03 0.02 0.04 NS NS NS NS
Values are median [range] NS - not significant. 310
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TABLE 3. Patients Satisfaction Grading Excision and marsupialization group
Radiofrequency sinus excision group
7.8 [7.3-8.1]
9.2 [8.9-9.4]
Mean score [Range]
Values are median [range]. (Visual analogue scale 0 ⫽ Dissatisfied. 10 ⫽ satisfied).
imation of wound leading to tension and subsequent pain and discomfort.18 Hospital Stay Although the patients operated with radiofrequency procedure were discharged within 12 hours of the procedure, the average duration of hospital stay was 33 hours in patients operated by marsupialization.19,20 The reason for this was because of the type of anesthesia, postoperative pain, and discomfort. Period Off Work The patients operated by radiofrequency technique were able to join their duties much earlier than the patients operated by marsupialization method. This was possible because of the reduced pain, and minimal discomfort in body movements21. The patients from the radiofrequency group were found more comfortable with movements like sitting, walking, and performing routine activities than their counterparts, which encouraged them to resume duties early. Shafik has described use of electrocauterization in the treatment of pilonidal sinus.22 However, this technique invariably results in damage to the adjacent healthy tissues further, causing more pain and delay in wound healing.23 Nd: YAG24 and Ruby lasers25 have been used in treating pilonidal disease and are reported to reduce pain, length of hospitalization, and early return to work. Although the radiofrequency instrument has almost all of the advantages of laser, it is free from disadvantages like the risk of misdirected reflected beams, the prolonged healing period involved, and the high cost of treatment with lasers.26 Another advantage of radio surgery is that malleable electrodes are available that could be selected to suit the exacting requirements of any surgical position. This is especially found of great help when working on a cavity of the pilonidal sinus with the presence of offending tissues.9 A follow-up of 1 year was found sufficient for the study. “Recurrences” occurring a year or more after surgery are usually because of formation of new sinuses and should be dealt with accordingly.27 Radiofrequency device allows cutting and coagulation of tissues in an atraumatic manner, contrary to the electric bistoury. The advantages of radiofrequency over electrocautery and laser energy surgery reside in its precision in ablating tissues and in its control of operation. With radiofrequency, the targeted tissue CURRENT SURGERY • Volume 61/Number 3 • May/June 2004
temperatures stay localized within a 60 to 90°C range, thus limiting heat dissipation and damage to adjacent tissue.21 In contrast, electrocautery, diathermy, and laser temperatures are significantly higher (750 to 900°C), which result in significant heat propagation in excess of the desired therapeutic need. These differences allow for radiofrequency being found more accurate, minimally invasive, and less morbid without compromising the treatment efficacy and durability.23 Although techniques using conventional scalpel apparently works in an atraumatic way, the prominence of bleeding from the wound forces the surgeon to coagulate the bleeders with traditional electrocautery or diathermy more frequently than radiofrequency. The radio waves can seal the small blood vessels without creating any char, whereas the cautery or elcetrosurgical instruments create heat at the tip of the instruments to seal the affected portion with transferred heat, and in the process invariably damage the adjacent healthy tissues, which consequently cause more edema and postoperative pain.28 The patients treated with sinus excision technique by radiofrequency expressed greater satisfaction in comparison with the marsupialization group. This is explainable on the overall comfort ratio. The patients needed brief hospital stay and shorter period off work. With minimal postoperative pain, negligible wound complication and ease in the bodily movements, they found radiofrequency technique much more comfortable.
CONCLUSION An ideal treatment for chronic pilonidal disease would be the one that minimizes hospital stay, ensures early wound healing, avoids risk of complications, minimizes the rate of recurrence and involves minimal time off the work. The sinus excision technique by radiofrequency seems to fulfill most of these criteria. The patient satisfaction is perceptibly greater than that in the excision and marsupialization procedure. The study results do indicate that the sinus excision technique by radiofrequency could be an alternative option in the treatment of limited, chronic pilonidal disease.
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