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
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Jyrki T Makela
Scientific

University Hospital of Oulu
Department of Surgery
Division of Gastoenterology
P.O. Box 5000
Oulu
90140
Finland

Phone	+358 (0)8 315 2011
Email	jyrki.makela@oulu.fi

Study information

Study design	Randomised clinical 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 the contact details to request a patient 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	Current primary outcome measure as of 03/10/2019: 1. Defining the presence or absence of rectal prolapse and intussusseption with/without enterocele by MR-defecography 2. Three compartment anatomy evaluation by dynamic MRI using HMO classification for measurements Previous primary outcome measure: Anatomic result: 1. Clinical examination: defining the presence or absence of rectal prolapse/intussusseption 2. 3D endoanal ultrasound: situation of the mesh with regard to anal sphincter complex 3. MRI-defecography: objective measure of presence/absence of rectal prolapse/ intussusseption Functional result: 1. Symptom questionnaires: 1.1. Obstructive Defecation Score (ODS) 1.2. Wexner (for anal incontinence symptoms) 1.3. Pelvic Floor Disorder Interventory (PFDI-20), including Urinary Distress Inventory 6 (UDI-6) 1.4. Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) and Colorectal-Anal Distress Inventory 8 (CRADI-8) Quality of life impact: 1. A condition specific quality of life questionnaire: Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7) 2. 15D - A generic quality of life questionnaire
Secondary outcome measures	Current secondary outcome measures as of 03/10/2019: 1. Functional result by symptom questionnaires: 1.1. Obstructive Defecation Score (for obstructed defecation symptoms) 1.2. Wexner score (for anal incontinence symptoms) 1.3. Pelvic Floor Disorder Interventory (PFDI-20), including Urinary Distress Inventory 6 (UDI- 6), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) and Colorectal-Anal Distress Inventory 8 (CRADI-8) 1.4 Sexual function: Pelvic Organ Prolapse / Urinary Incontinence Sexual Function Questionnaire (PISQ-12) 2. The effect on rectopexy to three compartment pelvic anatomy 2.1. Pelvic organ prolapse staging using pelvic organ prolapse quantification (POP-Q) method Previous secondary outcome measures: 1. Operative parameters and postoperative recovery 2. Cost-benefit analysis (HRQoL by using the 15D instrument) 3. The effect on rectopexy to gynacologic organs/prolapses: 3.1. Gynaecological examination and pelvic organ prolapse staging using pelvic organ prolapse quantification (POP-Q) method 3.2. Dynamic MRI using HMO classification for measurements 4. Sexual function: Pelvic Organ Prolapse / Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Overall study start date	01/02/2012
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 number of participants	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

University Hospital of Oulu

Oulu
90140
Finland

Sponsor information

University Hospital of Oulu (Finland)
Hospital/treatment centre

Department of Surgery
Division of Gastroenterology
PO Box 21
Oulu
90029 OYS
Finland

"ROR"	https://ror.org/045ney286

Funders

Funder type

Hospital/treatment centre

Oulu University Hospital (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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.