Condition category
Digestive System
Date applied
12/09/2012
Date assigned
23/10/2012
Last edited
14/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

31/08/2014

Reason abandoned

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

Sponsor information

Organisation

University Hospital of Oulu (Finland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/02/2017: Plain English summary added.