Original Article
Prospective Randomized Study of Marsupialization versus Silver Nitrate Application in the Management of Bartholin Gland Cysts and Abscesses Ozlem Ozdegirmenci, MD*, Fulya Kayikcioglu, MD, and Ali Haberal, MD From the Turkiye Cumhuriyeti Saglik Bakanligi (Healthy Ministry, Republic of Turkey) Ankara Etlik Maternity and Women’s Health Teaching Research Hospital, Gynecology Clinic, Ankara, Turkey (all authors).
ABSTRACT Study Objective: To prospectively compare the efficacy of marsupialization or silver nitrate application in the treatment of Bartholin gland cysts abscesses, both of which are widely used as outpatient procedures. Design: Prospective randomized trial. Design classification I. Setting: Teaching and research hospital, a tertiary center. Patients: A total of 212 patients admitted to our gynecology clinic with symptomatic Bartholin gland cysts/abscesses. Interventions: Marsupialization and silver nitrate application in Bartholin gland cysts/abscesses. Measurements and Main Results: In all, the 212 patients were randomly allocated to either marsupialization (group I) or silver nitrate application (group II) from March 2005 through March 2007. A total of 159 women were eligible for reevaluation at the end of the sixth month. In all, 83 were randomized to group I and 76 to group II. The patients were called for revisits at day 3, day 7, month 1, and month 6 of treatment. The 2 groups were compared for recurrence rates as primary outcome and duration of procedures, complications, size of scar tissues, and presence of dyspareunia as secondary outcomes. Comparisons of 2 groups were evaluated by Pearson c2 test and Mann-Whitney U test, as appropriate. The 2 groups were comparable with regard to age, parity, and diameter of cyst or abscess. The recurrence rates were similar: 24.1% in group I and 26.3% in group II at 6 months (p 5.67). No statistically significant differences were found in respect to duration of procedures or presence of dyspareunia. Complete healing without scar formation was observed in 31.3% and 55.7% of patients in groups I and II, respectively, and this was statistically significant (p 5.007). Conclusion: Marsupialization and silver nitrate application seem to be equally effective management methods in Bartholin cyst and abscesses, however, silver nitrate favors complete healing with less scar formation. Journal of Minimally Invasive Gynecology (2009) 16, 149–152. Keywords:
Bartholin cyst; Bartholin abscess; Marsupialization; Silver nitrate
Bartholin gland cysts and abscesses are common problems in women of reproductive age, accounting for 2% of all gynecologic visits per year. It is a frustrating condition for patients when symptoms occur; they often experience discomfort during coitus or pain while sitting or walking. Various management options are available for Bartholin gland cysts or abscesses including simple incision and drainage, placement of a Word catheter, marsupialization, carbon-dioxide laser, Corresponding author: Ozlem Ozdegirmenci, MD, Yesiltepe 2, Blok, No: 86 TR06510 Emek, Ankara, Turkey. E-mail:
[email protected] The authors have no commercial, proprietary, or financial interest in the products or companies described in this article. Submitted August 30, 2008. Accepted for publication October 20, 2008. 1553-4650/$ - see front matter doi:10.1016/j.jmig.2008.10.006
and application of silver nitrate with different failure rates [1]. Although the definitive treatment is surgical excision, it is generally recommended only in recurrent cases or in postmenopausal patients [2]. Furthermore, it is not an office-based procedure. The purpose of this study was to prospectively compare the efficacy of marsupialization or silver nitrate application, both of which are widely used outpatient procedures in our clinic. To our knowledge, no study to date in the English-language literature has compared these 2 procedures. Materials and Methods This was a prospective randomized study at a tertiary teaching and research hospital. Postmenopausal patients and those with recurrence refractory to previous treatments
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were scheduled directly to excision. All remaining patients with symptomatic Bartholin gland cysts or abscesses were included in this study from March 2005 through March 2007. The local ethics committee provided approval for the study before patient enrollment. Inclusion criteria were patients at reproductive age, with no previous intervention for Bartholin gland cyst or abscess and presence of symptoms. Bilateral cysts or abscesses and suspicious masses in labia majora, further assessed with pelvic magnetic resonance imaging, were excluded. Women were counseled about both of the procedures and randomized to either marsupialization (group I) or silver nitrate (group II) regardless of the content and size of the cyst. Randomization was based on computer-generated codes that were maintained in sequentially numbered opaque envelopes until just before use. The randomization envelopes were opened and the designated treatment started. Demographic characteristics including age, parity, mode of delivery, and symptoms were noted. After collection of a thorough history, gynecologic examination was performed. Both procedures were conducted under local anesthesia and in an outpatient setting. All procedures were managed by 3 gynecologists with the same techniques. After the patient was placed in the lithotomic position, infiltration of 2% lidocaine to the skin just lateral to hymen was followed by preparation of the skin with iodine. After the stabilization of the cyst manually, a 1.5- to 2-cm vertical incision was made with a thin-edged scalpel. In group I, the cyst wall was opened. The cyst was drained of its contents. The edges were grasped and the cavity was irrigated with saline and the cyst wall was everted to the skin edge with interrupted 2-0 absorbable sutures (polyglactin 910) (Fig. 1). In group II, after a 1.5- to 2-cm vertical incision, we grasped the skin edges and dissected the skin from the cyst wall. We sutured the upper and lower edges of cyst wall with 2 interrupted 2-0 absorbable/ nonabsorbable sutures and only incised the cyst wall between them. After the evacuation of the content and irrigation with saline, 1 piece of solid 0.5- ! 0.5-cm silver nitrate was inserted into the cavity from the incised opening between 2 sutures. The procedure was completed with knotting the 2 sutures to prevent the leakage of silver nitrate (Fig. 2). At day-3 visit, the suture was removed with the coagulated tissue. All patients were prescribed ciprofloxacin and analgesic without culturing, and sexual intercourse was discouraged. The content as cyst or abscess and the size of the cyst along with the duration of procedure were recorded. All patients were called for revisits at day 3, day 7, month 1, month 6, and at 3-day intervals until the suture could be removed in group II and healing was completed. Healing was defined as epithelization of the wound. In the presence of significant pain, bleeding, or unusual symptoms, patients were advised to return to our emergency department. The patients were examined for early complications at the first 2 follow-up visits. The contrary management option was offered initially in case of symptomatic recurrences. The 2 groups were compared for recurrence rates as primary outcome and duration of procedures, complications,
Journal of Minimally Invasive Gynecology, Vol 16, No 2, March/April 2009 Table 1
Characteristics of groups Characteristic
Group I (n 5 83), median (range)
Group II (n 5 76), median (range)
p
Age (years) Parity Cyst/abscess diameter (cm) Procedure duration (min)
33 (21–50) 2 (0–5) 3 (1.5–7) 15 (3–30)
32 (17–49) 1 (0–6) 3 (1–5) 15 (5–30)
.18 .33 .57 .70
size of scar tissues, and presence of dyspareunia after the procedure as secondary outcomes. Statistical analysis was performed by using software (SPSS 10.0 for Windows, SPSS Inc, Chicago, IL). Kolmogorov-Smirnov test was used for normality analysis. Comparisons of 2 groups were evaluated by Pearson c2 test and Mann-Whitney U test, as appropriate. Skewed data were shown as median and range. Power analysis of the study showed that age, parity, diameter of the cyst/abscess, and duration of the procedure all had greater than 80% power to reveal differences. Results In all, 212 patients who met inclusion criteria were enrolled. A total of 53 patients were lost to follow-up (23 patients from Group I and 30 patients from Group II); the remaining 159 were eligible. In all, 83 were randomized to group I and 76 to group II. All the patients who did not attend the 6-month visit were contacted by telephone. We could not contact those who were lost to follow-up for reasons such as wrong telephone number, moving to another city, or not responding. In group I, 2 patients were pregnant and both of them were treated successfully. In group II, 4 treatment failures were observed at the second visit because of inappropriate technique. The suture could not be removed because the sutures were not completely on cyst wall but on vulvar skin. Two of them preferred excision after counseling and the other 2 underwent marsupialization. The patients who underwent marsupialization did not experience recurrence for 1 year. No significant differences existed between the 2 groups with respect to age, parity, diameter of cyst or abscess, or duration of procedure (Table 1). The mean removal time of the suture in group II was 4.26 6 2.35 days. Groups were comparable in terms of mode of delivery (p 5.89). There were 19 (23.2% vs 25% in groups I and II, respectively) nulliparas in both groups. In all, 55 (67.1%) and 46 (60.6%) patients had uncomplicated spontaneous vaginal deliveries with episiotomy whereas 8 and 11 patients had Table 2
Recurrence characteristics Recurrence
Group I (n 5 83)
Group II (n 5 76)
p
No. of patients Median/range time of recurrence (mo)
20 (24.1%) 1.5 (1–6)
20 (26.3) 2 (0.25–6)
.67 .29
Ozdegirmenci et al.
Treatment for Bartholin’s Gland Cysts and Abscesses
Table 3
Management of recurrences Management
Group I (n 5 20)
Group II (n 5 20)
Follow-up Spontaneous drainage Silver nitrate Marsupialization Excision Refusal of retreatment
11 1 8 – – –
4 3 1 6 4 2
cesarean deliveries in groups I and II, respectively. No statistically significant difference existed between groups with respect to presence of cyst or abscess [42 (52.5%) vs 30 (40.5%) cysts in groups I and II, respectively; p 5.62]. The recurrence rates were similar: 24.1% in group I and 26.3% in group II. The 4 patients with incomplete removal of cyst wall in group II were considered as having recurrence. Mean recurrence time was similar in the 2 groups (Table 2). Management in cases of recurrences is outlined in Table 3. None of the patients recurred after remanaged via either technique. At the end of the first month, all patients had a complete regeneration of the tissues. Complete healing without scar formation was observed in 31.3% and 55.7% patients in groups I and II, respectively, and this was statistically significant (p 5.007). In group I, 7 (8.4%) patients reported discharge from the operation site whereas 5 (6.02%) patients had labial edema in initial follow-up visits. In group II, a labial chemical burn was found in 2 (2.63%) and hematoma was observed in 3 (3.94%) patients. In these patients healing was completed
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with scar formation. Febrile morbidity was not observed in either group. At 6 months, 7 (8.4%) patients in group I and 4 (5.3%) patients in group II had mild dyspareunia and no statistically significant difference existed between groups (p 5.11). Discussion The diagnosis and treatment of Bartholin gland cysts will continue to be a mainstay of gynecology. Various methods have been described with variable recurrence rates. Conventional treatment is marsupialization. Studies on marsupialization have reported overall recurrence rate ranging from 2% to 25% that is also similar to Word catheter results [1]. Silver nitrate application has been used in Bartholin cysts and abscesses successfully. A team reported the results of 52 patients with Bartholin abscesses or cysts including recurrent cysts treated by silver nitrate and 3.8% had recurrences within the first 2 months [3]. A team treated 17 patients with cysts or abscesses with silver nitrate application but observed 1 recurrence at day 8 caused by incomplete coagulation, which was completely healed after with the same technique [4]. An author reported managing 15 cysts with 93% success and in 1 patient the cyst wall could not be expelled [5]. The studies comparing the techniques in Bartholin gland cysts/abscesses are very limited. One study compared excision with silver nitrate application for Bartholin gland cysts and abscesses and concluded that silver nitrate was as effective as excision [6]. One team investigated the efficiency of alcohol sclerotherapy by comparing it with silver nitrate in cyst or abscesses and reported that alcohol sclerotherapy was as effective as silver nitrate application [7]. We thought that it
Fig. 1. Appearance of Bartholin cyst in group I before (A) and immediately after (B) procedure and on first (C) and third (D) months in different patients.
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Journal of Minimally Invasive Gynecology, Vol 16, No 2, March/April 2009
Fig. 2. Patient in group II at baseline (A), 7 days (B), 1 month (C), and 3 months (D).
would be valuable to compare silver nitrate application with a widely used method such as marsupialization. Before the beginning of our study, both marsupialization and silver nitrate procedures were considered standard treatments in our center, with well-developed protocols for each. Choice of one therapy over the other was mostly a matter of surgeon preference. In our study, no difference between therapies concerning treatment failure was indicated. Failures as a result of incomplete technique were more likely in silver nitrate group. Our recurrence rate especially in silver nitrate group seems higher than the other teams’ results. The patients attending the revisits might be the more problematic cases; thus, those who recovered were lost to follow-up and recurrence rates seemed to be increased. In addition, the relatively large number lost to follow-up might contain a disproportionate number of failures in one group or the other. Healing without scar formation was the only statistically significant difference between the groups, favoring silver nitrate application. Symptoms of patients in treatment groups were different. In the marsupialization group, discharge from the operation site was the most common symptoms whereas chemical burn and hematoma were the main findings in silver nitrate group.
In conclusion, this report is unique with its large sample size. Marsupialization and silver nitrate application seem equally effective management methods in Bartholin cyst and abscesses, however, silver nitrate favors complete healing with less scar formation. References 1. Marzano DA, Haefner HK. The Bartholin gland cyst: past, present and future. J Low Genit Tract Dis. 2004;8:195–204. 2. Markusen TE, Barclay DL. Benign disorders of the vulva and vagina. In: DeCherney AH, Nathan L, editors. Current Obstetric and Gynecologic Diagnosis and Treatment. 9th ed. Los Angeles: McGraw Hill; 2003. p. 651–676. 3. Yu¨ce K, Zeyneloglu HB, Bu¨ku¨lmez O, Kisnisci HA. Outpatient management of Bartholin gland abscesses and cysts with silver nitrate. Aust N Z J Obstet Gynaecol. 1994;34:93–96. 4. Turan C, Vicdan K, Go¨kmen O. The treatment of Bartholin’s cyst and abscess with silver nitrate. Int J Gynaecol Obstet. 1995;48:31–38. 5. Ergeneli MH. Silver nitrate for Bartholin gland cysts. Eur J Obstet Gynecol Reprod Biol. 1999;82:231–232. 6. Mungan T, Ug˘ur M, Yalcın H, Alan S, Sayigan A. Treatment of Bartholin’s cyst and abscess: excision versus silver nitrate insertion. Eur J Obstet Gynecol Reprod Biol. 1995;63:61–63. 7. Kafalı H, Yurtseven S, Ozardali I. Aspiration and alcohol sclerotherapy: a novel method for management of Bartholin’s cyst or abscess. Eur J Obstet Gynecol Reprod Biol. 2004;112:98–101.