Pilonidal SinusNCT00672555

Limberg-flap: Prospective Data Collection

A study testing Limberg-flap in people with Pilonidal Sinus, run by Cantonal Hospital of St. Gallen at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Pilonidal Sinus
What is being tested?: Limberg-flap
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 2 sitesSwitzerland
Study dates: Aug 2006to Sep 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

Department of sugery, Cantonal hospital of St. Gallen
Rorschach, Canton of St. Gallen, 9400
Department of surgery, Cantonal hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

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

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

Read the detailed description

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.

Conditions: Pilonidal Sinus
Being tested: Limberg-flap
Keywords: pilonidal sinus, recurrence, Limberg flap
Medical subject headings: Pilonidal Sinus, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Limberg-flapProcedure or surgery
Also called Romboid-flap
Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock

Study groups in NCT00672555
Study group	Role	What they receive
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. Receives: Procedure: Limberg-flap

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year

Secondary outcomes (5)

Minor Complications (Wound Complications)
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.
Measured: 1 year
Reoperations Needed for Treatment of Complication
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.
Measured: 1year
Patient Overall Satisfaction With Procedure
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.
Measured: 1 year
Body Image Score
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.
Measured: 1 year
Cosmetic Score
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2006Sep 2009

First posted6 May 2008 (estimated)
Study startAug 2006
Primary completionJan 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pilonidal SinusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00672555
Sponsor's protocol ID: EKSG 07/050/2B
Status last verified: Jun 2011
First submitted: 1 May 2008
Last updated: 29 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 17726856
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.
PubMed 9788857
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.
PubMed 21383571

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Teach-Back Discharge Education After Pilonidal Sinus Surgery
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ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Pilonidal Sinus, Wound Healing
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Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
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All Pilonidal Sinus trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Evaluation of Feasibility and Results of the Treatment of Pilonidal Sinus by Excision and Covering of the Defect With a Limberg-flap.
ClinicalTrials.gov ID: NCT00672555
Acronym / sponsor ID: EKSG 07/050/2B
Conditions: Pilonidal Sinus
Keywords: pilonidal sinus, recurrence, Limberg flap
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Cantonal Hospital of St. GallenUniversity, hospital or other
Study start: Aug 2006
Primary completion: Jan 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 6 May 2008 (estimated)
Results: Posted 29 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pilonidal Sinus T. With Limberg F.	Experimental	Procedure: Limberg-flapAll 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Limberg-flapAlso: Romboid-flapComplete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock	Procedure or surgery	Pilonidal Sinus T. With Limberg F.

Primary outcome

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.

5 secondary outcomes

Minor Complications (Wound Complications)
Time frame: 1 year
Reoperations Needed for Treatment of Complication
Time frame: 1year
Patient Overall Satisfaction With Procedure
Time frame: 1 year
Body Image Score
Time frame: 1 year
Cosmetic Score
Time frame: 1 year

Results and safety

Results posted to the registry on 29 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilonidal Sinus Treated With Limberg Flap	70	64

Primary outcome: Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure

Time frame: 1 year. Number. Unit: participants

Measure	Pilonidal Sinus Treated With Limberg Flap n = 70
Value	1

Population analysed: Per protocol: All patients treated in the study period, who gave their informed consent and meet the inclusion criteria, as well did not have any reason for exclusion were enrolled prospectively

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilonidal Sinus Treated With Limberg Flap	0 of 70 (0%)	18 of 70 (25.7%)	Not reported

Limitations and caveats (from the sponsor): Study was conducted as planned. A long time was needed to get the follow-up information.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17726856Kapp 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.
Background: PubMed 9788857Dunker 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.
Results publication: PubMed 21383571Muller 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.

Related trials for Pilonidal Sinus

Recruiting
VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
Pilonidal Sinus Disease
Not yet recruiting
Teach-Back Discharge Education After Pilonidal Sinus Surgery
Pilonidal Sinus Disease, Pilonidal Sinus Treatment
Recruiting
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Pilonidal Sinus, Wound Healing
Not yet recruiting
Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
Pilonidal Cyst Without Abscess
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lukas Marti, M D principal investigator

Department of surgery, Cantonal hospital of St. Gallen

Franc H Hetzer, M D study chair

Department of surgery, Cantonal hospital of St. Gallen

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Limberg-flap in people with Pilonidal Sinus, run by Cantonal Hospital of St. Gallen at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00672555, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.