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Bascom Cleft Lift Versus Limberg Flap for Sacrococcygeal Pilonidal Sinus

T

Trabzon Numune Training and Research Hospital

Status

Unknown

Conditions

Pilonidal Sinus

Treatments

Procedure: Bascom Cleft Lift
Procedure: Limberg Flap

Study type

Interventional

Funder types

Other

Identifiers

NCT01337869
TNEAH-2010GC1

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Bascom Cleft Lift Technique
Active Comparator group
Treatment:
Procedure: Bascom Cleft Lift
Limberg Flap Technique
Active Comparator group
Treatment:
Procedure: Limberg Flap

Trial contacts and locations

1

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Central trial contact

Ali GUNER, M.D.; Aydin BOZ, M.D.

Data sourced from clinicaltrials.gov

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