Plain English Summary
Background and study aims
Hemorrhoids, or piles, are swellings containing enlarged blood vessels found inside or around the anus and rectum. Most piles are mild and do not cause any problems, but symptoms include bright red blood found after passing a stool, an itchy anus and a viable lump hanging down from the anus. Many cases go away on their own or can be treated by lifestyle changes or medications. Surgical treatment can be recommended, however, if other treatments do not work or are not suitable. A hemorrhoidectomy involves cutting out the hemorrhoids under general anaesthetic. A stapled haemorrhoidopexy involves stapling the last section of the large intestine (anorectum), which reduces the supply of blood to the haemorrhoids and causes them to gradually shrink. There are a number of different hemorrhoidectomy and haemorrhoidopexy techniques. Recent studies have compared the open and closed hemorrhoidectomy techniques with each other and to Longo’s hemorrhoidopexy technique, but no study has compared this new procedure with Parks’ hemorrhoidectomy or analysed all three of these surgical procedures. In this study, we aim to compare all of these surgical treatments to determine whether Longo’s technique is painless and associated with an earlier return to work.
Who can participate?
Patients with symptomatic hemorrhoids requiring surgical treatment who have not had a similar surgical procedure before.
What does the study involve?
The patients are randomly allocated to one of three groups. Those in group 1 undergo stapled rectal mucosectomy performed according to Longo’s surgical technique. Those in group 2 undergo open hemorrhoidectomy performed according to Milligan-Morgan’s technique. Those in group 3 undergo closed hemorrhoidectomy performed according to Park’s technique. All patients are operated on under general anaesthesia. All patients report on their experience of pain (according to VAS scale) in a home diary every morning before taking pain medications. All patients are followed by a single proctological specialist for the first week, including a rectal digital exploration, and then at two weeks, and at one, three and four months, including endoscopic examination. Finally, patients are contacted by telephone interview with an ambulatory visit in case of recurrence or other late complications.
What are the possible benefits and risks of participating?
There are no benefits or risks for the participants.
Where is the study run from?
Università Campus Bio-Medico di Roma, Rome (Italy)
When is the study starting and how long is it expected to run for?
April 1998 to January 2007
Who is funding the study?
Investigator initiated and funded (Italy)
Who is the main contact?
Dr Valter Ripetti
v.ripetti@unicampus.it
Trial website
Contact information
Type
Public
Primary contact
Dr Augusto Arullani
ORCID ID
http://orcid.org/0000-0003-0090-618X
Contact details
Via De Notaris 2b
Rome
00197
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised trial comparing stapled hemorrhoidopexy vs. open and closed hemorrhoidectomy.
Acronym
Study hypothesis
In patients with hemorrhoids, do stapled hemorrhoidopexy compared to traditional hemorrhoidectom lead to better short and long term outcomes?’
Ethics approval
Ethics committee of Università Campus Bio-Medico di Roma, 08/03/1999, ref: 9/99 ComET-CBM
Study design
Randomised interventional prospective trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Symptomatic hemorrhoids who were deemed to require surgical treatment
Intervention
180 patients into three arms of 60 patients. Stapled rectal mucosectomy was performed in group L according to the surgical technique described by Longo. Haemorrhoidectomy were performed according to Milligan-Morgan’s and Park’s techniques in group MM and P respectively. All patients were operated on under general anaesthesia
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Intensity of postoperative pain at discharge at the first week and at the return to work activity
Secondary outcome measures
1. Duration of surgery
2. Analgesic intake in the first week
3. The intensity of postoperative pain after the first week, spontaneously, at defecation and at digital anal exploration
4. Days required for return to physical activity
5. Days required for complete healing (the disappearance of all symptoms linked to the surgical procedure)
6. The incidence of recurrence; and minor or major complications
Overall trial start date
09/03/1999
Overall trial end date
27/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with symptomatic haemorrhoids who were deemed to require surgical treatment:
1. First haemorrhoidal surgery
2. Disease involving all three main peduncles
3. Residence within 50 km of the hospital (to allow close follow-up).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180 patients into three groups of 60 patients for group.
Participant exclusion criteria
1. Patients underwent at associated or previous other surgical procedure for perianal pathologies
2. Patients with preoperative incontinence
3. Patients with with contraindication for general anaesthesia
4. Retired
5. Unemployed
6. Underage
7. Pregnant
8. Patient with major physical or mental comorbidities
Recruitment start date
01/04/1999
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Italy
Trial participating centre
The Campus Bio-Medico University (Università Campus Bio-Medico di Roma)
Via Alvaro del Portillo 200
Rome
00128
Italy
Sponsor information
Organisation
The Campus Bio-Medico University (Università Campus Bio-Medico di Roma)
Sponsor details
Via Alvaro del Portillo 21
Rome
00128
Italy
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26445182