Urological and sexual function in males following robotic vs laparoscopic rectal surgery

ISRCTN ISRCTN14574075
DOI https://doi.org/10.1186/ISRCTN14574075
ClinicalTrials.gov number 211302
Secondary identifying numbers 32746, IRAS 211302
Submission date
30/01/2017
Registration date
30/01/2017
Last edited
05/02/2024
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Sofoklis Panteleimonitis
Scientific

Research & innovation
Poole Hospital
Longfleet Road
Poole
PO1 2FR
United Kingdom

ORCiD logoORCID ID 0000-0003-3610-1201

Study information

Study designRandomised; Interventional; Design type: Treatment, Surgery
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet ISRCTN14574075_PIS_18Jan17_V1.2.docx
Scientific titleUrological and sexual function in males following robotic vs laparoscopic rectal surgery: An international, multicentre, randomised control trail
Study acronymUROLE
Study objectivesThe 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(s)East of England - Cambridgeshire and Hertfordshire Research Ethics Committee, 20/01/2017, ref: 16/EE/0492
Health condition(s) or problem(s) studiedSpecialty: Surgery, Primary sub-specialty: General Surgery; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system
InterventionFollowing 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/02/2016
Completion date01/02/2019
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participantsPlanned Sample Size: 70; UK Sample Size: 40
Total final enrolment0
Key inclusion criteria1. 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)
Key exclusion criteria1. Sexually inactive
2. Advanced tumours involving adjacent organs
3. Surgery performed with palliative intent
4. Unplanned/ emergency surgery
Date of first enrolment01/03/2017
Date of final enrolment01/03/2018

Locations

Countries of recruitment

  • England
  • Portugal
  • United Kingdom

Study participating centres

Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
Frimley Park Hospital
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom
Leeds Teaching Hospitals
Great George Street
Leeds
LS1 3EX
United Kingdom
Champalimaud Clinical Centre
Champalimaud Foundation
Champalimaud Centre for the Unknown
Avenida Brasília
Lisbon
1400-038
Portugal

Sponsor information

Poole Hospital NHS Foundation Trust
Hospital/treatment centre

Longfleet Road
Poole
BH15 2JB
England
United Kingdom

ROR logo "ROR" https://ror.org/03kdm3q80

Funders

Funder type

Industry

Intuitive Surgical, Inc.

No information available

Results and Publications

Intention to publish date01/02/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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 planThe datasets generated during and/or analysed during the current study will be available upon request from UP799673@myport.ac.uk

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V1.2 18/01/2017 13/02/2017 No Yes
HRA research summary 28/06/2023 No No
Other publications 05/02/2024 Yes No

Additional files

ISRCTN14574075_PIS_18Jan17_V1.2.docx
Uploaded 13/02/2017
ISRCTN14574075_Brief results statement.pdf

Editorial Notes

05/02/2024: The following changes were made:
1. The IRAS number was added.
2. A brief results statement was added by the sponsor explaining that the project does not have any results due to early termination with no participants recruited. A total final enrolment was added.
13/02/2017: Verified study information with principal investigator.