Condition category
Surgery
Date applied
30/01/2017
Date assigned
30/01/2017
Last edited
13/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Sponsor information

Organisation

Poole Hospital NHS Foundation Trust

Sponsor details

Longfleet Road
Poole
BH15 2JB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/02/2017: Verified study information with principal investigator.