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Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

NCT ID: NCT02287935

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-09-30

Brief Summary

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It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Detailed Description

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Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery.

It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Conditions

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Recurrent Pilonidal Sinus Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Limberg flap

Patients were divided into two groups, group 1 were treated with Limberg flap technique

Group Type ACTIVE_COMPARATOR

Limberg flap

Intervention Type PROCEDURE

Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions

Karydakis procedure

Patients were divided into two groups, group 2 were treated with Karydakis procedure

Group Type ACTIVE_COMPARATOR

Karydakis procedure

Intervention Type PROCEDURE

Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions

Interventions

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Limberg flap

Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions

Intervention Type PROCEDURE

Karydakis procedure

Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients willing to give written informed consent
2. There should be recurrent pilonidal sinus

2\. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus

3\. International normalizing ratio (INR) less than 1.5

4\. Prothrombin time (PT) should be less than 15 s

5\. Partial thromboplastin (PTT) time should be near normal

6\. Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding

7\. There must be no infection at the time of surgery

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Exclusion Criteria

1. Patients not willing to give informed consent
2. Age less than 16 years
3. Patient presenting with conditions mimicking pilonidal sinus
4. Diabetes mellitus, renal failure, immunosuppression e.g. were excluded

\-
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Adana Numune Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mehmet Aziret

Doc. Dr. Selim Sözen, A. Prof. Dr. İlhan Bali

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Bali I, Aziret M, Sozen S, Emir S, Erdem H, Cetinkunar S, Irkorucu O. Effectiveness of Limberg and Karydakis flap in recurrent pilonidal sinus disease. Clinics (Sao Paulo). 2015 May;70(5):350-5. doi: 10.6061/clinics/2015(05)08. Epub 2015 May 1.

Reference Type DERIVED
PMID: 26039952 (View on PubMed)

Other Identifiers

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AdanaNTRH

Identifier Type: -

Identifier Source: org_study_id