Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus

NCT01337869 | Unknown DMC

• 1 other identifier: TNEAH-2010GC1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Sinus

Keywords

Bascom Procedure, Limberg, Pilonidal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• early recurrence rate

  up to 6 months

• Healing time

  within 30 days

• operative time

  during surgical procedure (day 1)

• hospital stay

  during first week (one week)

Study Arms (2)

Bascom Cleft Lift Technique

ACTIVE COMPARATOR

Procedure: Bascom Cleft Lift

Limberg Flap Technique

ACTIVE COMPARATOR

Procedure: Limberg Flap

Interventions

Bascom Cleft Lift PROCEDURE

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.

Also known as: Bascom Procedure

Bascom Cleft Lift Technique

Limberg Flap PROCEDURE

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.

Also known as: Limbergplasty

Limberg Flap Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• acute abscess formation (Cruse-Foord Class IV)
• patient with minor inflammation are included to trial after two-week antibiotic treatment (Cruse-Foord Class III)

Sponsors & Collaborators

• Trabzon Numune Training and Research Hospital: lead

Study Sites (1)

Trabzon Numune Training and Research Hospital

Trabzon, 61040, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Bascom J, Bascom T. Failed pilonidal surgery: new paradigm and new operation leading to cures. Arch Surg. 2002 Oct;137(10):1146-50; discussion 1151. doi: 10.1001/archsurg.137.10.1146.

  PMID: 12361421 BACKGROUND

• Mentes O, Bagci M, Bilgin T, Ozgul O, Ozdemir M. Limberg flap procedure for pilonidal sinus disease: results of 353 patients. Langenbecks Arch Surg. 2008 Mar;393(2):185-9. doi: 10.1007/s00423-007-0227-9. Epub 2007 Sep 22.

  PMID: 17899165 BACKGROUND

• Nordon IM, Senapati A, Cripps NP. A prospective randomized controlled trial of simple Bascom's technique versus Bascom's cleft closure for the treatment of chronic pilonidal disease. Am J Surg. 2009 Feb;197(2):189-92. doi: 10.1016/j.amjsurg.2008.01.020. Epub 2008 Jul 17.

  PMID: 18639221 BACKGROUND

• Jamal A, Shamim M, Hashmi F, Qureshi MI. Open excision with secondary healing versus rhomboid excision with Limberg transposition flap in the management of sacrococcygeal pilonidal disease. J Pak Med Assoc. 2009 Mar;59(3):157-60.

  PMID: 19288942 BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Central Study Contacts

Ali GUNER, M.D.

CONTACT

draliguner@yahoo.com

Aydin BOZ, M.D.

CONTACT

draydin@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 19, 2011

Record last verified: 2011-04

Locations

TU (1)