Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jyrki T Makela
ORCID ID
Contact details
University Hospital of Oulu
Department of Surgery
Division of Gastoenterology
P.O. Box 5000
Oulu
90140
Finland
+358 (0)8 315 2011
jyrki.makela@oulu.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Robotic assisted versus laparoscopic ventral rectopexy in the treatment of rectal prolapse or enterocele with secondary rectal intussusseption: a randomised trial
Acronym
Study hypothesis
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
Ethical Committee of the Medical Faculty, University of Oulu, 14/11/2011, ref: 264
Study design
Randomised clinical 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 the contact details to request a patient information sheet
Condition
Rectal prolapse or enterocele with secondary intussusseption
Intervention
Robotic assisted versus laparoscopic ventral rectopexy
Intervention type
Other
Phase
Not Applicable
Drug names
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 trial start date
01/02/2012
Overall trial end date
31/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
1. Significant systemic illness (ASA > 4)
2. Suspicion of frozen pelvis
3. Pregnant or future plans for pregnancy
Recruitment start date
01/02/2012
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Finland
Trial participating centre
University Hospital of Oulu
Oulu
90140
Finland
Funders
Funder type
Hospital/treatment centre
Funder name
Oulu University Hospital (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list