Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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|
- Quality of life and postoperative pain [ Time Frame: within 30 days ] [ Designated as safety issue: No ]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
- early recurrence rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]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.
- Healing time [ Time Frame: within 30 days ] [ Designated as safety issue: No ]determine wound healing time. the time until complete recovery will be presented.
- operative time [ Time Frame: during surgical procedure (day 1) ] [ Designated as safety issue: No ]the time between the beginning of the procedure and last skin suture.
- hospital stay [ Time Frame: during first week (one week) ] [ Designated as safety issue: No ]the time to until discharge.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Bascom Cleft Lift Technique||
Procedure: Bascom Cleft Lift
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.
Other Name: Bascom Procedure
|Active Comparator: Limberg Flap Technique||
Procedure: Limberg Flap
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.
Other Name: Limbergplasty
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337869
|Contact: Ali GUNER, M.D.||email@example.com|
|Contact: Aydin BOZ, M.D.||firstname.lastname@example.org|
|Trabzon Numune Training and Research Hospital||Recruiting|
|Trabzon, Turkey, 61040|
|Contact: Ali Guner, M:D: 90-4622302301 ext 1822 email@example.com|
|Principal Investigator: Ali GUNER, M.D.|
|Principal Investigator: Aydin BOZ, M.D.|
|Sub-Investigator: Can KECE, M.D.|
|Sub-Investigator: Erhan REIS, MD,Professor|
|Sub-Investigator: Omer F. Ozkan, M.D.|
|Sub-Investigator: Izzettin KAHRAMAN, M.D.|
|Sub-Investigator: Omer Ileli, M.D.|