Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
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

Dr MRB Keighley

ORCID ID

Contact details

GI Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265109328

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Surgery: anterior resection and pouch construction

Intervention

We should recruit 40 consenting patients in each group (AR and IPAA) to be randomly assigned to receive a single perioperative dose of topical 0.2% GTN (glycerine trinitrate) ointment or nothing. All patients to be assessed pre- and post-operatively with a clinical incontinence assessment, anorectal manometry and transanal ultrasound.

Intervention type

Drug

Phase

Not Applicable

Drug names

Glycerine trinitrate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/06/2002

Overall trial end date

08/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All patients submit to anterior resection (AR) and ileal pouch-anal anastomosis (IPAA)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/06/2002

Recruitment end date

08/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

GI Surgery
Birmingham
B15 2TH
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

University Hospital Birmingham NHS 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

Publication citations

Additional files

Editorial Notes