Condition category
Digestive System
Date applied
03/09/2007
Date assigned
26/10/2007
Last edited
30/10/2008
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 Roger Gerjy

ORCID ID

Contact details

Department of Surgery
University Hospital
Linkoping
SE- 581 85
Sweden

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

http://www.lio.se/templates/Page.aspx?id=4033

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

  1. 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.

Additional files

Editorial Notes