An open prospective multicentre randomised study of haemorrhoid excision (Milligan-Morgan) and stapled anopexy (Longo) for the treatment of prolapsing haemorrhoids
ISRCTN | ISRCTN68315343 |
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DOI | https://doi.org/10.1186/ISRCTN68315343 |
Secondary identifying numbers | N/A |
- Submission date
- 18/11/2007
- Registration date
- 21/02/2008
- Last edited
- 08/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Per-Olof Nystrom
Scientific
Scientific
Karolinska Institute
Department of Surgical Gastroenterology
Karolinska University Hospital Huddinge
Stockholm
14186
Sweden
per-olof.nystrom@karolinska.se |
Study information
Study design | Multi-centre randomised 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 acronym | STOPP (Stapled or Open Pile Procedure) trial |
Study objectives | To prove that stapled anopexy produces better or at least similar clinical outcome compared to the Milligan-Morgan operation. The outcomes assessed are: 1. Self-reported symptom reduction (submitted by the patients) 2. Anatomical normalisation (submitted by the surgeons) |
Ethics approval(s) | Ethics approval was obtained for each participating Hospital. Main approval was granted by the Ethics Committee of Linkoping University (Sweden) on the 8th October 1999 (ref: 99099). |
Health condition(s) or problem(s) studied | Haemorrhoid prolapse |
Intervention | 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 |
Intervention type | Other |
Primary outcome measure | 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 outcome measures | 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 |
Overall study start date | 01/05/1999 |
Completion date | 31/12/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 200 |
Key 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 |
Key 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 |
Date of first enrolment | 01/05/1999 |
Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- Denmark
- Sweden
- United Kingdom
Study participating centre
Karolinska Institute
Stockholm
14186
Sweden
14186
Sweden
Sponsor information
Ethicon Endo-Surgery (Germany)
Industry
Industry
Ethicon Endo-Surgery (Europe) GmbH
Hummelsbuttler Steindamm 71
Norderstedt
22851
Germany
per-olof.nystrom@karolinska.se | |
https://ror.org/023edjq13 |
Funders
Funder type
Industry
Ethicon Endo-Surgery Europe (Germany)
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 | 01/02/2010 | Yes | No |