NCT00672555

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 29, 2011

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

2.4 years

First QC Date

May 1, 2008

Results QC Date

April 28, 2010

Last Update Submit

June 3, 2011

Conditions

Pilonidal Sinus

Keywords

pilonidal sinusrecurrenceLimberg flap

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 year

Secondary Outcomes (5)

  • Minor Complications (Wound Complications)

    1 year

  • Reoperations Needed for Treatment of Complication

    1year

  • Patient Overall Satisfaction With Procedure

    1 year

  • Body Image Score

    1 year

  • Cosmetic Score

    1 year

Study Arms (1)

Pilonidal Sinus T. With Limberg F.

EXPERIMENTAL

All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.

Procedure: Limberg-flap

Interventions

Limberg-flapPROCEDURE

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

Also known as: Romboid-flap
Pilonidal Sinus T. With Limberg F.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of sugery, Cantonal hospital of St. Gallen

Rorschach, Canton of St. Gallen, 9400, Switzerland

Location

Department of surgery, Cantonal hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Related Publications (3)

  • Kapp T, Zadnikar M, Hahnloser D, Soll Ch, Hetzer FH. [New concept in the treatment of the pilonidal sinus]. Praxis (Bern 1994). 2007 Aug 2;96(31-32):1171-6. doi: 10.1024/1661-8157.96.31.1171. German.

    PMID: 17726856BACKGROUND

  • Dunker MS, Stiggelbout AM, van Hogezand RA, Ringers J, Griffioen G, Bemelman WA. Cosmesis and body image after laparoscopic-assisted and open ileocolic resection for Crohn's disease. Surg Endosc. 1998 Nov;12(11):1334-40. doi: 10.1007/s004649900851.

    PMID: 9788857BACKGROUND

  • Muller K, Marti L, Tarantino I, Jayne DG, Wolff K, Hetzer FH. Prospective analysis of cosmesis, morbidity, and patient satisfaction following Limberg flap for the treatment of sacrococcygeal pilonidal sinus. Dis Colon Rectum. 2011 Apr;54(4):487-94. doi: 10.1007/DCR.0b013e3182051d96.

    PMID: 21383571RESULT

MeSH Terms

Conditions

Pilonidal SinusRecurrence

Condition Hierarchy (Ancestors)

CystsNeoplasmsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was conducted as planned. A long time was needed to get the follow-up information.

Results Point of Contact

Title
Lukas Marti; principal investigator
Organization
Department of surgery, Cantonal hospital of St. Gallen
lukas.marti@kssg.ch
0041794120153

Study Officials

  • Lukas Marti, M D

    Department of surgery, Cantonal hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

  • Franc H Hetzer, M D

    Department of surgery, Cantonal hospital of St. Gallen

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 6, 2008

Study Start

August 1, 2006

Primary Completion

January 1, 2009

Study Completion

September 1, 2009

Last Updated

June 29, 2011

Results First Posted

June 29, 2011

Record last verified: 2011-06

Locations

CH(2)