Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Stapled anopexy under perianal local block is as effective as surgery under general anaesthesia and provides a similar clinical outcome.
Ethics approval
Approved by the Committee of Research and Ethics, University Hospital, Linkoping (Sweden) on the 11th March 2003 (ref: 03-087).
Study design
Ramdomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mucoanal prolapse
Intervention
Perianal local anaestetic block versus general anaesthesia for stapled anopexy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/04/2004
Overall trial end date
30/11/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/04/2004
Recruitment end date
30/11/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Surgery
Linkoping
SE- 581 85
Sweden
Sponsor information
Organisation
County Council of Ostergotland (Sweden)
Sponsor details
University Hospital
Linkoping
SE-581 85
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
County Council of Ostergotland (Sweden) (ref: 060-48559)
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/18844245
Publication citations
-
Results
Gerjy R, Lindhoff-Larson A, Sjödahl R, Nyström PO, Randomized clinical trial of stapled haemorrhoidopexy performed under local perianal block versus general anaesthesia., Br J Surg, 2008, 95, 11, 1344-1351, doi: 10.1002/bjs.6379.