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Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus

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ClinicalTrials.gov Identifier: NCT01337869
Recruitment Status : Unknown
Verified April 2011 by Trabzon Numune Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Trabzon Numune Training and Research Hospital

April 15, 2011
April 19, 2011
April 19, 2011
January 2011
October 2011   (Final data collection date for primary outcome measure)
Quality of life and postoperative pain [ Time Frame: 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
Same as current
No Changes Posted
  • early recurrence rate [ Time Frame: 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 [ Time Frame: within 30 days ]
    determine wound healing time. the time until complete recovery will be presented.
  • operative time [ Time Frame: during surgical procedure (day 1) ]
    the time between the beginning of the procedure and last skin suture.
  • hospital stay [ Time Frame: during first week (one week) ]
    the time to until discharge.
Same as current
Not Provided
Not Provided
 
Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus
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
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Pilonidal Sinus
  • 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
  • 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
  • Active Comparator: Bascom Cleft Lift Technique
    Intervention: Procedure: Bascom Cleft Lift
  • Active Comparator: Limberg Flap Technique
    Intervention: Procedure: Limberg Flap

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
December 2011
October 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT01337869
TNEAH-2010GC1
Yes
Not Provided
Not Provided
Ali GUNER, M.D., Trabzon Numune Training and Research Hospital, Department of General Surgery
Trabzon Numune Training and Research Hospital
Not Provided
Not Provided
Trabzon Numune Training and Research Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP