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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

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.

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: Bascom Cleft Lift Procedure: Limberg Flap Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Healing time [ Time Frame: within 30 days ]
    determine wound healing time. the time until complete recovery will be presented.

  3. operative time [ Time Frame: during surgical procedure (day 1) ]
    the time between the beginning of the procedure and last skin suture.

  4. hospital stay [ Time Frame: during first week (one week) ]
    the time to until discharge.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337869


Contacts
Contact: Ali GUNER, M.D. draliguner@yahoo.com
Contact: Aydin BOZ, M.D. draydin@msn.com

Locations
Turkey
Trabzon Numune Training and Research Hospital Recruiting
Trabzon, Turkey, 61040
Contact: Ali Guner, M:D:    90-4622302301 ext 1822    draliguner@yahoo.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.         
Sponsors and Collaborators
Trabzon Numune Training and Research Hospital