Pilonidal Sinus
Conditions
Keywords
Bascom Procedure, Limberg, Pilonidal Disease
Brief summary
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.
Interventions
PROCEDUREBascom 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.
PROCEDURELimberg 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.
Sponsors
Trabzon Numune Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and postoperative pain | within 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| early recurrence rate | up to 6 months | 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 | within 30 days | determine wound healing time. the time until complete recovery will be presented. |
| operative time | during surgical procedure (day 1) | the time between the beginning of the procedure and last skin suture. |
| hospital stay | during first week (one week) | the time to until discharge. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAli GUNER, M.D.
Backup ContactAydin BOZ, M.D.
Outcome results
None listed