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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19930199
Enrollment
50
Registered
2007-10-26
Start date
2004-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucoanal prolapse Digestive System Mucoanal prolapse

Interventions

Perianal local anaestetic block versus general anaesthesia for stapled anopexy.

Sponsors

County Council of Ostergotland (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026