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
-
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.