Robotic assisted versus laparoscopic ventral rectopexy in the treatment of rectal prolapse or enterocele with secondary rectal intussusception
| ISRCTN | ISRCTN88884232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88884232 |
| Protocol serial number | N/A |
| Sponsor | University Hospital of Oulu (Finland) |
| Funder | Oulu University Hospital (Finland) |
- Submission date
- 12/09/2012
- Registration date
- 23/10/2012
- Last edited
- 25/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
A rectal prolapse is when part of the rectum protrudes (sticks out) through the anus, or in a less severe form an internal prolapse (intussusception), when the rectum folds in on itself but doesn't stick out through the anus. It can cause pain and make it difficult to control bowel movements. Rectal prolapse can be surgically treated by laparoscopic ventral rectopexy, a keyhole operation where the rectum is suspended back into its normal position. Robot-assisted laparoscopy is a new technology which provides conditions for more precise surgery in narrow conditions. In the operation the surgeon directs robotic arms through a console by means of hand controls and pedals. Robot-assisted laparoscopy has been proven safe and feasible, but more costly and time-consuming than conventional laparoscopy. The aim of this study is to compare conventional laparoscopic ventral rectopexy to robot-assisted laparoscopy.
Who can participate?
Female patients aged between 18 and 85 with rectal prolapse requiring surgical treatment
What does the study involve?
Participants are randomly allocated into two groups, to undergo either the laparoscopic or robot-assisted operation. The effects of the surgery on pelvic floor function and quality of life are assessed using questionnaires before the operation and during follow-up visits. Follow-up visits involve a clinical examination including a gynecological examination and an MRI scan.
What are the possible benefits and risks of participating?
There is no reward paid for the participation in the study. The follow-up visits and the MRI scan are free of charge. Participation in the study carries no additional risks and the MRI scan causes no radiation exposure.
Where is the study run from?
Oulu University Hospital (Finland)
When is study starting and how long is it expected to run for?
February 2012 to August 2014
Who is funding the study?
Oulu University Hospital (Finland)
Who is the main contact?
Prof. Jyrki T Makela
jyrki.makela@oulu.fi
Contact information
Scientific
University Hospital of Oulu
Department of Surgery
Division of Gastoenterology
P.O. Box 5000
Oulu
90140
Finland
| Phone | +358 (0)8 315 2011 |
|---|---|
| jyrki.makela@oulu.fi |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Robotic assisted versus laparoscopic ventral rectopexy in the treatment of rectal prolapse or enterocele with secondary rectal intussusseption: a randomised trial |
| Study objectives | Robotic assisted technique may offer advantages over the conventional laparoscopic ventral rectopexy in terms of postoperative recovery, anatomic and functional results and quality of life impact. |
| Ethics approval(s) | Ethical Committee of the Medical Faculty, University of Oulu, 14/11/2011, ref: 264 |
| Health condition(s) or problem(s) studied | Rectal prolapse or enterocele with secondary intussusseption |
| Intervention | Robotic assisted versus laparoscopic ventral rectopexy |
| Intervention type | Other |
| Primary outcome measure(s) |
Current primary outcome measure as of 03/10/2019: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 03/10/2019: |
| Completion date | 31/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Female |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Female patient between 18 and 85 years of age 2. Patient suitable for day-case surgery and general anaesthesia [American Society of Anesthesiologists (ASA 1-3)] 3. Previously untreated and uncomplicated rectal prolapse or enterocele 4. Isolated rectal prolapse or enterocele with intussusception |
| Key exclusion criteria | 1. Significant systemic illness (ASA > 4) 2. Suspicion of frozen pelvis 3. Pregnant or future plans for pregnancy |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- Finland
Study participating centre
90140
Finland
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/11/2019: The overall end date was changed from 31/08/2014 to 31/08/2017.
03/10/2019: The following changes were made to the trial record:
1. The primary outcome measure has been changed.
2. The secondary outcome measures have been changed.
14/02/2017: Plain English summary added.
