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Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus

Primary Purpose

Pilonidal Sinus

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bascom Cleft Lift
Limberg Flap
Sponsored by
Trabzon Numune Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring Bascom Procedure, Limberg, Pilonidal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Trabzon Numune Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bascom Cleft Lift Technique

Limberg Flap Technique

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

early recurrence rate
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
determine wound healing time. the time until complete recovery will be presented.
operative time
the time between the beginning of the procedure and last skin suture.
hospital stay
the time to until discharge.

Full Information

First Posted
April 15, 2011
Last Updated
April 18, 2011
Sponsor
Trabzon Numune Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01337869
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Trabzon Numune Training and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
Bascom Procedure, Limberg, Pilonidal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bascom Cleft Lift Technique
Arm Type
Active Comparator
Arm Title
Limberg Flap Technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Bascom Cleft Lift
Other Intervention Name(s)
Bascom Procedure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Limberg Flap
Other Intervention Name(s)
Limbergplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life and postoperative pain
Description
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
Time Frame
within 30 days
Secondary Outcome Measure Information:
Title
early recurrence rate
Description
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.
Time Frame
up to 6 months
Title
Healing time
Description
determine wound healing time. the time until complete recovery will be presented.
Time Frame
within 30 days
Title
operative time
Description
the time between the beginning of the procedure and last skin suture.
Time Frame
during surgical procedure (day 1)
Title
hospital stay
Description
the time to until discharge.
Time Frame
during first week (one week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali GUNER, M.D.
Email
draliguner@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aydin BOZ, M.D.
Email
draydin@msn.com
Facility Information:
Facility Name
Trabzon Numune Training and Research Hospital
City
Trabzon
ZIP/Postal Code
61040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Guner, M:D:
Phone
90-4622302301
Ext
1822
Email
draliguner@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ali GUNER, M.D.
First Name & Middle Initial & Last Name & Degree
Aydin BOZ, M.D.
First Name & Middle Initial & Last Name & Degree
Can KECE, M.D.
First Name & Middle Initial & Last Name & Degree
Erhan REIS, MD,Professor
First Name & Middle Initial & Last Name & Degree
Omer F. Ozkan, M.D.
First Name & Middle Initial & Last Name & Degree
Izzettin KAHRAMAN, M.D.
First Name & Middle Initial & Last Name & Degree
Omer Ileli, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
12361421
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.
Results Reference
background
PubMed Identifier
17899165
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.
Results Reference
background
PubMed Identifier
18639221
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.
Results Reference
background
PubMed Identifier
19288942
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.
Results Reference
background

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Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus

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