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

ISRCTN ISRCTN19930199
DOI https://doi.org/10.1186/ISRCTN19930199
Secondary identifying numbers N/A
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

Study designRamdomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesStapled 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) studiedMucoanal prolapse
InterventionPerianal local anaestetic block versus general anaesthesia for stapled anopexy.
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/04/2004
Completion date30/11/2005

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants50
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2004
Date of final enrolment30/11/2005

Locations

Countries of recruitment

  • Sweden

Study participating centre

Department of Surgery
Linkoping
SE- 581 85
Sweden

Sponsor information

County Council of Ostergotland (Sweden)
Government

University Hospital
Linkoping
SE-581 85
Sweden

Website http://www.lio.se/templates/Page.aspx?id=4033
ROR logo "ROR" https://ror.org/0326gsy75

Funders

Funder type

Government

County Council of Ostergotland (Sweden) (ref: 060-48559)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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