Condition category
Ear, Nose and Throat
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Neal Cripps

ORCID ID

Contact details

Directorate of Surgery
St Richard's Hospital
Spitalfield Lane
Chichester
PO19 4SE
United Kingdom
neil.cripps@rws-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0213108766

Study information

Scientific title

Acronym

Study hypothesis

To test the hypothesis that Bascom's procedure for pilonidal sinus is as successful as cleft closure with respect to postoperative complications, time to complete healing and long-term recurrence rate.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Ear, Nose and Throat: Pilonidal sinus disease

Intervention

Randomised to treatment by Bascom's procedure or cleft closure.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 16
2. Chronic pilonidal sinus disease that consultant considers to be suitable for Bascom's procedure
3. Patient willing to attend long-term follow-up

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Added 05/05/10: 55

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Directorate of Surgery
Chichester
PO19 4SE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Royal West Sussex Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18639221

Publication citations

  1. Results

    Nordon IM, Senapati A, Cripps NP, A prospective randomized controlled trial of simple Bascom's technique versus Bascom's cleft closure for the treatment of chronic pilonidal disease., Am. J. Surg., 2009, 197, 2, 189-192, doi: 10.1016/j.amjsurg.2008.01.020.

Additional files

Editorial Notes