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

ISRCTN ISRCTN68315343
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

Karolinska Institute
Department of Surgical Gastroenterology
Karolinska University Hospital Huddinge
Stockholm
14186
Sweden

Email per-olof.nystrom@karolinska.se

Study information

Study designMulti-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymSTOPP (Stapled or Open Pile Procedure) trial
Study objectivesTo 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) studiedHaemorrhoid prolapse
InterventionHalf 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 typeOther
Primary outcome measure1. 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 measures1. 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 date01/05/1999
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants200
Key inclusion criteria1. 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 criteria1. 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 enrolment01/05/1999
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • Denmark
  • Sweden
  • United Kingdom

Study participating centre

Karolinska Institute
Stockholm
14186
Sweden

Sponsor information

Ethicon Endo-Surgery (Germany)
Industry

Ethicon Endo-Surgery (Europe) GmbH
Hummelsbuttler Steindamm 71
Norderstedt
22851
Germany

Email per-olof.nystrom@karolinska.se
ROR logo "ROR" https://ror.org/023edjq13

Funders

Funder type

Industry

Ethicon Endo-Surgery Europe (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2010 Yes No