A randomised trial of Bascom's procedure versus cleft closure for the management of primary pilonidal sinus disease

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Neal Cripps
Scientific

Directorate of Surgery
St Richard's Hospital
Spitalfield Lane
Chichester
PO19 4SE
United Kingdom

Email	neil.cripps@rws-tr.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ear, Nose and Throat: Pilonidal sinus disease
Intervention	Randomised to treatment by Bascom's procedure or cleft closure.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	55
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2001
Date of final enrolment	31/12/2004

Directorate of Surgery

Chichester
PO19 4SE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2009		Yes	No