Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus

Study Overview
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Brief Summary
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A pilonidal sinus is a cyst on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. Limberg Flap technique is frequently used technique for this disease all over the world. However, Bascom Cleft Lift Technique is relatively newer technique. The purpose of this prospective randomized study is comparison of these techniques about patient satisfaction for postoperative period.

Official Title
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Comparison of Bascom Cleft Lift Technique Versus Limberg Flap Closure for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Controlled Trial Evaluating for Patient Satisfaction and Early Recurrence

Conditions
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Pilonidal Sinus

Intervention / Treatment
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* Procedure: Bascom Cleft Lift
* Procedure: Limberg Flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All types of pilonidal sinus or cyst The patient understands trial information and is capable of making a decision for informed consent after having received information. The patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial. Exclusion Criteria: acute abscess formation (Cruse-Foord Class IV) patient with minor inflammation are included to trial after two-week antibiotic treatment (Cruse-Foord Class III)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bascom Cleft Lift Technique<br> | Procedure: Bascom Cleft Lift<br>* Patients are positioned prone. The skin incision is drawn on the natal cleft, marking out the area of skin to be excised. The skin from this side of the natal cleft is then elevated. The skin on the opposite side of the cleft then is undermined to a distance required to allow primary closure of the defect away from the midline without tension. The elevated skin island is excised. The sinuses remaining in the deeper tissues are curetted thoroughly. Hemostasis is maintained. A 12F low-suction drain is sited and fat of the natal cleft then is approximated by using an absorbable suture. The wound is closed with a 3-0 polypropylene suture.The drain remains in situ to time that drainage amount decreases below 20 ml/day. The suture is removed in the clinic 10 day after surgery.<br>* Other names: Bascom Procedure;|
| Active Comparator: Limberg Flap Technique<br> | Procedure: Limberg Flap<br>* Patients are positioned prone. The area to be excised is mapped-out, and the flap is designed. The area to be excised is mapped on the skin in a rhomboid form. The skin incision is deepened to the presacral fascia. Tissue is removed en bloc. After removing the rhombic excision, the Limberg fascia cutaneous flap is prepared through the right or left-side gluteus maximus fascia. The flap is fully mobilized and transposed medially to fulfill the rhombic defect without any tension. Hemosthasis is accomplished. A 12F low-suction drain is sited and wound is closed in two layers: the subcutaneous tissue with absorbable suture and the skin with 3/0 polypropylene. drain remains in situ to time that drainage amount decreases below 20 ml/day. The suture is removed in the clinic 10 day after surgery.<br>* Other names: Limbergplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and postoperative pain | Determine patient satisfaction factors using the quality of life survey (SF-36 form) on the 10th-30th day and postoperative pain by using post-operative visual analog pain scale on the 2nd-10th day | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early recurrence rate | participants will be followed for the duration of hospital stay and first 30 days, up to 6 months. at the end of the study, recurrence rates will be presented for both groups. | up to 6 months | 
| Healing time | determine wound healing time. the time until complete recovery will be presented. | within 30 days | 
| operative time | the time between the beginning of the procedure and last skin suture. | during surgical procedure (day 1) | 
| hospital stay | the time to until discharge. | during first week (one week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bascom Procedure, Limberg, Pilonidal Disease