An open prospective multicentre randomised study of haemorrhoid excision (Milligan-Morgan) and stapled anopexy (Longo) for the treatment of prolapsing haemorrhoids

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68315343

Enrollment

200

Registered

2008-02-21

Start date

1999-05-01

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

Haemorrhoid prolapse Circulatory System Haemorrhoid prolapse

Interventions

Half of the participants were randomised to the intervention group and another half to the control group. Intervention group: Stapled anopexy Control group: Conventional diathermy haemorrhoidecomy

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Self-reported symptom reduction, assessed by a symptom questionnaire filled by the patients pre-treatment and at one year after surgery 2. Anatomical normalisation - a standard assessment of the anatomy by the surgeons before and at one year after surgery 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.	—

Measure

Time frame

1. Self-reported symptom reduction, assessed by a symptom questionnaire filled by the patients pre-treatment and at one year after surgery 2. Anatomical normalisation - a standard assessment of the anatomy by the surgeons before and at one year after surgery 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

Measure	Time frame
1. Operation time 2. Theatre time 3. Complexity of each operation, rated by the surgeon 4. Hospital stay 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. 6. Sick leave 7. Complications, assessed at 3 - 4 month visit to surgeon 8. Adverse events or course, assessed at 3 - 4 month visit to surgeon	—

Measure

Time frame

1. Operation time 2. Theatre time 3. Complexity of each operation, rated by the surgeon 4. Hospital stay 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. 6. Sick leave 7. Complications, assessed at 3 - 4 month visit to surgeon 8. Adverse events or course, assessed at 3 - 4 month visit to surgeon

—

Countries

Denmark, Sweden, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026