Limberg and Karydakis Flap in Recurrent… | Clinical Trial

Key information

Conditions

Recurrent Pilonidal Sinus Disease Cysts Neoplasms Pilonidal Sinus

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

International normalizing ratio (INR) less than 1.5

Prothrombin time (PT) should be less than 15 s

Partial thromboplastin (PTT) time should be near normal

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

There must be no infection at the time of surgery

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Exclusion criteria

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

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Treatment and study plan

Limberg flap

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

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

Primary outcomes

Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease

Time frame: January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals

Superiority as measured by rates of recurrence and complication, length of hospital stay, return work, VAS skore, patient satisfaction and complet healing duration.

Sponsors and collaborators

Lead sponsor

Adana Numune Training and Research Hospital

Other Gov

Registry information

Official study title

Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Nov 11, 2014
Registry last updated: Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed