Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Trabzon Numune Training and Research Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Trabzon Numune Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01337869
First received: April 15, 2011
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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 Intervention
Pilonidal Sinus
Procedure: Bascom Cleft Lift
Procedure: Limberg Flap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by Trabzon Numune Training and Research Hospital:

Primary Outcome Measures:
  • Quality of life and postoperative pain [ Time Frame: within 30 days ] [ Designated as safety issue: No ]
    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:
  • early recurrence rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    determine wound healing time. the time until complete recovery will be presented.

  • operative time [ Time Frame: during surgical procedure (day 1) ] [ Designated as safety issue: No ]
    the time between the beginning of the procedure and last skin suture.

  • hospital stay [ Time Frame: during first week (one week) ] [ Designated as safety issue: No ]
    the time to until discharge.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Ali GUNER, M.D., Trabzon Numune Training and Research Hospital, Department of General Surgery
ClinicalTrials.gov Identifier: NCT01337869     History of Changes
Other Study ID Numbers: TNEAH-2010GC1
Study First Received: April 15, 2011
Last Updated: April 18, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Trabzon Numune Training and Research Hospital:
Bascom Procedure, Limberg, Pilonidal Disease

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014