An open prospective multicentre randomised study of haemorrhoid excision (Milligan-Morgan) and stapled anopexy (Longo) for the treatment of prolapsing haemorrhoids
Completed
- Conditions
- Haemorrhoid prolapseCirculatory System
- Registration Number
- ISRCTN68315343
- Lead Sponsor
- Ethicon Endo-Surgery (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1. Haemorrhoid grade III or IV
2. Prolapse of one or more haemorrhoids on examination, together with parts of the anal canal, or a prolapse that can be provoked by digital traction on the (reduced) haemorrhoid
Exclusion Criteria
1. Retained anal canal
2. No consistent history of haemorrhoid prolapse
3. A history of severe anal fistula (high fistula) or a ruptured anal sphincter (obstetric injury) will usually disqualify the patient from participation in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Self-reported symptom reduction, assessed by a symptom questionnaire filled by the patients pre-treatment and at one year after surgery<br>2. Anatomical normalisation - a standard assessment of the anatomy by the surgeons before and at one year after surgery<br><br>There was also a follow-up visit at 3 - 4 months after surgery, at which the symptom questionnaire and anatomical assessment were carried out. However, the results of these assessments were not included in the final trial outcome; they served the purpose of assessing adverse events and complications.
- Secondary Outcome Measures
Name Time Method 1. Operation time<br>2. Theatre time<br>3. Complexity of each operation, rated by the surgeon<br>4. Hospital stay<br>5. Postoperative pain score. Patients were provided with a diary with instructions to score their pain (0 - 10 visual analogue scale) for each of the first 14 days, beginning from day 1 after surgery. The diary also reported on recovery and use of pain medication.<br>6. Sick leave<br>7. Complications, assessed at 3 - 4 month visit to surgeon<br>8. Adverse events or course, assessed at 3 - 4 month visit to surgeon