Randomised trial of stapled anopexy in local perianal block or general anaesthesia
ISRCTN | ISRCTN19930199 |
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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
Scientific
Department of Surgery
University Hospital
Linkoping
SE- 581 85
Sweden
Study information
Study design | Ramdomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/04/2004 |
Completion date | 30/11/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Other |
Sex | Both |
Target number of participants | 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
SE- 581 85
Sweden
Sponsor information
County Council of Ostergotland (Sweden)
Government
Government
University Hospital
Linkoping
SE-581 85
Sweden
Website | http://www.lio.se/templates/Page.aspx?id=4033 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 01/11/2008 | Yes | No |