Clinical trial NCT01337869: Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Sinus
Keywords: Bascom Procedure, Limberg, Pilonidal Disease
Lead sponsor: Trabzon Numune Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2011-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Quality of life and postoperative pain
timeFrame: within 30 days
Secondary outcomes:
measure: early recurrence rate
timeFrame: up to 6 months
measure: Healing time
timeFrame: within 30 days
measure: operative time
timeFrame: during surgical procedure (day 1)
measure: hospital stay
timeFrame: during first week (one week)
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Trabzon Numune Training and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.