Comparing stapled hemorrhoidopexy vs. open and closed hemorrhoidectomy.
| ISRCTN | ISRCTN12040297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12040297 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/02/2015
- Registration date
- 19/02/2015
- Last edited
- 13/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
Via De Notaris 2b
Rome
00197
Italy
 ORCID ID |
0000-0003-0090-618X |
|---|
Study information
| Study design | Randomised interventional prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | A randomised trial comparing stapled hemorrhoidopexy vs. open and closed hemorrhoidectomy. |
| Study objectives | In patients with hemorrhoids, do stapled hemorrhoidopexy compared to traditional hemorrhoidectom lead to better short and long term outcomes?’ |
| Ethics approval(s) | Ethics committee of Università Campus Bio-Medico di Roma, 08/03/1999, ref: 9/99 ComET-CBM |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 09/03/1999 |
| Completion date | 27/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 180 patients into three groups of 60 patients for group. |
| Key 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). |
| Key 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 |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00128
Italy
Sponsor information
University/education
Via Alvaro del Portillo 21
Rome
00128
Italy
| Website | http://www.unicampus.it/homepage |
|---|---|
"ROR" |
https://ror.org/04gqx4x78 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | Yes | No |
Editorial Notes
13/01/2016: Publication reference added.
