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NCT Number: NCT00672555

Limberg-flap: Prospective Data Collection

The investigators think, that the treatment of pilonidal sinus with excision and covering of the defect with a Limberg-flap is a very good treatment option. The investigators are introducing this treatment for recurrences of this illness in our clinic and want to analyse the feasibility, the results, the complications and the patients opinion after the treatment.

If the results are good, a prospective randomised study is a further option.

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Key information

Conditions

Pilonidal Sinus Cysts Disease Attributes Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of sugery, Cantonal hospital of St. Gallen, Rorschach, Canton of St. Gallen, Switzerland

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About this study

  • Patients, that come to our clinic with problems caused by a pilonidal sinus are informed about the different treatment options of the illness.
  • If the patient suffers of a recurrence of the illness, a complete excision, followed by a covering of the defect with a Limberg-flap is recommended.
  • If the patient has the first time problems by a pilonidal sinus, we recommend an open limited excision of the fistulas.
  • In cases with acute infected situation, we first conduct a very limited incision/excision and treat them with antibiotics. The treatments mentioned before are in such cases offered 3 to 4 Weeks after the fist little operation.
  • All Patients, that wish their pilonidal sinus treated with a complete excision followed by a covering of the defect with a Limberg-flap, are asked if they are willing to participate in the observational study.
  • Patients, who gave their informed consent for the operation and the study are included.
  • Preoperative data are recorded.
  • The patients are operated on and intraoperative data (e.g. how big was the flap) are recorded.
  • After 3 Weeks the patients are checked and complications, happiness and duration of the time off work are recorded.
  • After a year the patients are contacted by sending them a postal questionnaire, which they send back to us. Additionally the are contacted by phone. Recurrence, other complications and their opinion concerning the treatment and its consequences are recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recurrence or persistence of a pilonidal sinus
  • Elective Limberg-flap operation
  • Written informed consent of the patient for the operation and participation of the study

Exclusion criteria

  • Doubts of the capability of the patient to understand the study or to decide.

Treatment and study plan

Limberg-flap

Procedure

Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock

Other names: Romboid-flap

Primary outcomes

  1. Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure

    Time frame: 1 year

    At 1 year all patients were assessed. Patients with a recurrence of a pilonidal sinus were counted. The result is given as number of patients suffering from a recurrence.

Secondary outcomes

  1. Minor Complications (Wound Complications)

    Time frame: 1 year

    All wound complications were assessed; part of them being only very minor dehiscences or slight infections. They were assessed in the outpatients clinic at 3 Weeks and in the follow-up control initiated at 1 year. All patients suffering from a wound complication that occurred in the first year were counted.

  2. Reoperations Needed for Treatment of Complication

    Time frame: 1year

    All patients were seen at the outpatients clinic at 3 weeks. Follow-up control was initiated at 1 year.

    All reoperations that were done were assessed and measured.

  3. Patient Overall Satisfaction With Procedure

    Time frame: 1 year

    Follow-up was initiated at 1 year. A postal questionnaire was sent to the patients with a VAS assessing overall satisfaction. Possible values were: lowest: 0; highest 10.

  4. Body Image Score

    Time frame: 1 year

    Patients was sent a postal questionnaire at 1 year, assessing body image with the body image questionnaire adapted from Dunker et al. Body image score resulting form 5 questions: worst 5; best 20.

  5. Cosmetic Score

    Time frame: 1 year

    Patients was sent a postal questionnaire at 1 year, assessing cosmesis with the body image questionnaire adapted from Dunker et al. Cosmetic score resulting form 3 questions: worst 3; best 24.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Prospective Evaluation of Feasibility and Results of the Treatment of Pilonidal Sinus by Excision and Covering of the Defect With a Limberg-flap.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 6, 2008
Registry last updated
Jun 29, 2011

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.

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