Randomised trial of stapled anopexy in local perianal block or general anaesthesia

ISRCTN	ISRCTN19930199
DOI	https://doi.org/10.1186/ISRCTN19930199
Protocol serial number	N/A
Sponsor	County Council of Ostergotland (Sweden)
Funder	County Council of Ostergotland (Sweden) (ref: 060-48559)

Submission date: 03/09/2007
Registration date: 26/10/2007
Last edited: 30/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Roger Gerjy
Scientific

Department of Surgery
University Hospital
Linkoping
SE- 581 85
Sweden

Study information

Primary study design	Interventional
Study design	Ramdomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Stapled anopexy under perianal local block is as effective as surgery under general anaesthesia and provides a similar clinical outcome.
Ethics approval(s)	Approved by the Committee of Research and Ethics, University Hospital, Linkoping (Sweden) on the 11th March 2003 (ref: 03-087).
Health condition(s) or problem(s) studied	Mucoanal prolapse
Intervention	Perianal local anaestetic block versus general anaesthesia for stapled anopexy.
Intervention type	Other
Primary outcome measure(s)	1. Symptom resolution after the operation was measured by five symptom questions (bleeding, pruritus, soiling, pain and prolapse) and graded by their frequency. The five symptoms were assessed at pre-operative examination and post-operative reexamination which was scheduled approximately 3 - 6 months after the procedure 2. Restoration of anatomy in the anal canal was measured by a post-operative examination 3 - 6 months after the operation
Key secondary outcome measure(s)	1. Surgeon's ratings of severity of the disease, complexity of the operation and success of the operation were measured with a 7-point scale. They were registered with protocol during the pre-operative examination, during the operation and during post-operative examination 3 - 6 months post-operatively 2. Post-operative pain, post-operative course and complications were measured by a patient dairy and at examination 3. Operation time and staple line height were registered during the operation
Completion date	30/11/2005

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Patients with mucoanal prolapse that needed manual reposition of the prolapse or had confirmed prolapse at examination 2. No age restriction 3. Patients had to be considered suitable for either general anaesthesia or a local anaesthetic block
Key exclusion criteria	1. Patients who were considered unsuitable for a general anaesthetic in the context of a minor anal prolapse 2. Patients with other condition than mucoanal prolapse
Date of first enrolment	01/04/2004
Date of final enrolment	30/11/2005

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Surgery

Linkoping
SE- 581 85
Sweden

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/11/2008		Yes	No