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
Protocol serial number	N/A
Sponsor	Ethicon Endo-Surgery (Germany)
Funder	Ethicon Endo-Surgery Europe (Germany)

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

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

United Kingdom
Denmark
Sweden

Study participating centre

Karolinska Institute

Stockholm
14186
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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