Condition category
Circulatory System
Date applied
18/11/2007
Date assigned
21/02/2008
Last edited
08/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Per-Olof Nystrom

ORCID ID

Contact details

Karolinska Institute
Department of Surgical Gastroenterology
Karolinska University Hospital Huddinge
Stockholm
14186
Sweden
per-olof.nystrom@karolinska.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

STOPP (Stapled or Open Pile Procedure) trial

Study hypothesis

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

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).

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/1999

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/05/1999

Recruitment end date

31/12/2001

Locations

Countries of recruitment

Denmark, Sweden, United Kingdom

Trial participating centre

Karolinska Institute
Stockholm
14186
Sweden

Sponsor information

Organisation

Ethicon Endo-Surgery (Germany)

Sponsor details

Ethicon Endo-Surgery (Europe) GmbH
Hummelsbuttler Steindamm 71
Norderstedt
22851
Germany
per-olof.nystrom@karolinska.se

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Ethicon Endo-Surgery Europe (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20035531

Publication citations

  1. Results

    Nyström PO, Qvist N, Raahave D, Lindsey I, Mortensen N, , Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse., Br J Surg, 2010, 97, 2, 167-176, doi: 10.1002/bjs.6804.

Additional files

Editorial Notes