Plain English Summary
Background and study aims:
Rectal resection surgery is an operation to remove part or all of the rectum (the final part of the large intestine, ending in the anus). It is usually performed on patients with serious medical conditions such as rectal cancer or ulcerative colitis (a condition that causes long-term swelling (inflammation) in the large intestine and rectum). Urological (relating to urination) and sexual dysfunction are common after rectal resection surgery. This is mainly due to damage to the nerves in the pelvis during the surgery. Robotic surgery allows for precision surgery in the pelvis and can enable better preservation of those nerves. This could therefore ultimately lead to better preservation of function after rectal surgery. The aim of this study is to test find out whether robotic rectal surgery offers better urological and sexual functional outcomes when compared to standard laparoscopic (keyhole) surgery.
Who can participate?
Male sexually active adult patients requiring rectal resection surgery.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group undergo rectal resection surgery using the robotic method. Those in the second group undergo rectal resection surgery using the laproscopic method. Before surgery and then three, six and twelve months later, participants in both groups complete questionnaires about their sexual and urological function.
What are the possible benefits and risks of participating?
There are no benefits or risks involved with participation to this study. However, the results of this study could benefit others in the future.
Where is the study run from?
1. Poole Hospital (UK)
2. Frimley Park Hospital (UK)
3. Leeds Teaching Hospitals (UK)
4. Champalimaud Clinical Centre (Portugal)
When is the study starting and how long is it expected to run for?
February 2016 to February 2019
Who is funding the study?
Intuitive Surgical, Inc. (UK)
Who is the main contact?
Mr Sofoklis Panteleimonitis
email: UP799673@myport.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Sofoklis Panteleimonitis
ORCID ID
http://orcid.org/0000-0003-3610-1201
Contact details
Research & innovation
Poole Hospital
Longfleet Road
Poole
PO1 2FR
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
32746
Study information
Scientific title
Urological and sexual function in males following robotic vs laparoscopic rectal surgery: An international, multicentre, randomised control trail
Acronym
UROLE
Study hypothesis
The aim of this study is to evaluate the difference in urological and sexual function following two methods of minimally invasive rectal resectional surgery (robotic rectal surgery versus laparoscopic surgery).
Ethics approval
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee, 20/01/2017, ref: 16/EE/0492
Study design
Randomised; Interventional; Design type: Treatment, Surgery
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
See additional files
Condition
Specialty: Surgery, Primary sub-specialty: General Surgery; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system
Intervention
Following provision of informed consent, participants are randomised to one of two groups. Stratified randomisation will take place through the use of previously filled opaque concealed envelopes. Stratification will be based on whether patients have received pre-operative chemoradiotherapy or not. An equal number of patients will be randomised for each arm. Previously filled opaque concealed envelopes will ensure concealed allocation. To ensure true randomisation envelope sequence will have been generated by a random computer-generated number sequence
Group 1: Participants receive robotic rectal surgery. This involves rectal resection surgery with a robotic surgical system platform.
Group 2: Participants receive laparoscopic rectal surgery. This involves involves rectal resection surgery via means of laparoscopic instruments.
In both groups, surgery will take place at the operating room as per unit protocol and performed by the consultant surgeon. Participants will undergo a urodynamic assessment in first instance in the outpatients clinic by the research nurse or fellow and again during colorectal surgery post-operative follow up clinics.
Following surgery, the participants in both groups will receive standard post-operative care as per unit's standard practice. Outcome measures will be assessed at 3, 6 and 12 months following surgery. This will coincide with routine post-operative surgical follow up appointments.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Urological function is measured using the International Prostatic Symptoms Score (IPSS) pre-operatively and 3, 6 and 12 months after surgery
2. Sexual function is measured using the International Index of Erectile Function (IIEF) pre-operatively and 3, 6 and 12 months after surgery
3. Urodynamics (urine flow rate and post micturition residual urine volume) are assessed by a uroflow meter and a bladder scanner pre-operatively and 3, 6 and 12 months after surgery
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/02/2016
Overall trial end date
01/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a diagnosis of rectal cancer (≤15 cm from anal verge on MRI staging) amenable to curative surgery OR patients with ulcerative colitis having proctectomy and ileo-anal pouch
2. Male
3. Aged 18 years and over
4. Able to provide written informed consent
5. Fit enough to undergo minimally invasive surgery (ASA≤3)
6. Deemed suitable for minimally invasive surgery by local MDT
7. Elective case
8. Sexually active (this includes caressing, foreplay, masturbation and vaginal intercourse)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 70; UK Sample Size: 40
Participant exclusion criteria
1. Sexually inactive
2. Advanced tumours involving adjacent organs
3. Surgery performed with palliative intent
4. Unplanned/ emergency surgery
Recruitment start date
01/03/2017
Recruitment end date
01/03/2018
Locations
Countries of recruitment
Portugal, United Kingdom
Trial participating centre
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Trial participating centre
Frimley Park Hospital
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom
Trial participating centre
Leeds Teaching Hospitals
Great George Street
Leeds
LS1 3EX
United Kingdom
Trial participating centre
Champalimaud Clinical Centre
Champalimaud Foundation
Champalimaud Centre for the Unknown
Avenida Brasília
Lisbon
1400-038
Portugal
Funders
Funder type
Industry
Funder name
Intuitive Surgical, Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study’s findings will be written for publication for relevant high impact factor peer reviewed medical journals. Findings will also be submitted for presentation to high profile colorectal conferences such as the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting, the Association of Coloproctology of Great Britain and Ireland (ACPGBI) meeting, the European Association of Endoscopic Surgeons (EAES) meeting and the European Society of Coloproctology (ESCP) meeting. In addition, results will be presented at the Intuitive Surgical headquarters in Sunnyvale, USA, and Portsmouth Universities School of Health Sciences and Social Work (SHSSW) research seminars.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from UP799673@myport.ac.uk
Intention to publish date
01/02/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN14574075_PIS_18Jan17_V1.2.docx Uploaded 13/02/2017