A study of functional and immunological outcomes in people undergoing robotic and non-robotic rectal cancer surgery
| ISRCTN | ISRCTN14199232 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14199232 |
| IRAS number | 310837 |
| Secondary identifying numbers | CPMS 52049, IRAS 310837 |
- Submission date
- 12/05/2022
- Registration date
- 08/08/2022
- Last edited
- 08/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study is an observational, prospective, single-centre study comparing 2 surgical techniques used to treat rectal cancer patients. The investigated techniques will be the standard keyhole technique (also called laparoscopic or minimal invasive (MIS) surgery) and the robot-assisted technique. Robot-assisted surgery uses the robotic systems to aid the surgical procedures, providing more precision, flexibility, and control than is possible with standard keyhole technique. Our hypothesis is that this may also result in less harm to surrounding tissues.
Our main interests will be to compare the stress response after surgery and the restoration of digestive, urinary and sexual functions after surgery. We are looking to recruit 80 patients within 2 years with a follow-up period of 12 months.
Who can participate?
Adults over 18 years, diagnosed with rectal cancer
What does the study involve?
To compare the surgical stress response between the groups, we will be taking blood samples before surgery and on the first, third and fifth day after surgery (with the day of surgery being day 0). We will assess the functional outcomes through validated questionnaires filled in before surgery, and at 6 and 12 months after surgery.
The research team will also gather further information about the recovery and cancer treatment by reviewing the patient’s medical records during follow-up.
What are the possible benefits and risks of participating?
This study will not affect the surgical after care of patients in both groups. After completing this study, we hope to have a better insight into which technique causes less harm to the surrounding structures by observing the stress response and functional outcomes after rectal cancer surgery. The ambition of this work is to increase knowledge on surgical techniques for rectal cancer management, and to improve standard of care for these patients.
Where is the study run from?
Portsmouth Hospitals University NHS Trust (UK)
When is the study starting and how long is it expected to run for?
October 2021 to February 2025
Who is funding the study?
1. BASO ~ The Association for Cancer Surgery (UK)
2. Intuitive Foundation (USA)
Who is the main contact?
Prof Jim Khan jim.khan@porthosp.nhs.uk
Contact information
Scientific
Queen Alexandra Hospital, NHS Portsmouth
Colorectal Department
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
 ORCID ID |
0000-0002-3031-4495 |
|---|---|
| Phone | +44 2392 286000 |
| jim.khan@porthosp.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41750 PIS v2.4 06May2022.pdf |
| Scientific title | A prospective cohort study of Functional and Immunological outcomes after Laparoscopic and Robotic Total Meso-rectal Excision for rectal cancer |
| Study acronym | FILTER |
| Study objectives | Does robotic rectal cancer surgery result in a more precise dissection with a reduced immune/stress response and does it lead to better functional outcomes as compared to laparoscopic surgery? |
| Ethics approval(s) | Approved 15/03/2022, South Central - Hampshire B Research Ethics Committee (Health Research Authority, Skipton House, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 207 104 8089; hampshireb.rec@hra.nhs.uk), ref: 22/SC/0051 |
| Health condition(s) or problem(s) studied | Colorectal surgery for colorectal cancer |
| Intervention | The total study duration will be approximately 3 years. Study follow-up will be 12 months after date of surgery. Patients will have their blood drawn before surgery, and on days 1, 3 and 5 after surgery (with the date of surgery being day 0). Patients will be asked to fill in questionnaires on functional outcomes before surgery and at 6 and 12 months after surgery. The Baseline visit After informed consent is obtained, pre-operative baseline information will be collected. At this moment in time the participant will be asked to complete the pre-operative questionnaires on urinary function, sexual function, digestive function and the baseline quality of life questionnaires. A baseline bloodsample will be drawn. Patients have a standard of care preoperative clinical visit, where anorectal manometry measurements will be done if possible. The Operative Procedure visit During the operation routinely recorded parameters will be collected. These include how long the operation takes, system and instrument use, conversion to an open surgery and any complications during the surgery. The Post-Operative Course Following surgery, patients will be admitted to a ward as per standard clinical care. Patients will receive standard postoperative care as per clinical pathways, with all treatment decisions made as per clinician expertise. Study blood samples will be collected on days 1, 3 and 5 (with the date of surgery being day 0). Routinely patients are expected to be discharged on day 5, but if a patient is discharged home earlier than this there will be no need for additional blood sampling after discharged. For the purpose of calibration, we may need to draw extra blood for the first 10 patients. All study bloods are to be processed as per lab manual and routine blood tests (WBC, CRP, NRL, etc.) will be processed as per local procedure. Follow-up visits 30 days Around 30 days postoperatively, the patient’s records will be checked to assess postoperative complications, readmissions, patient related outcomes, surgical outcomes, and adverse events. 6 months At 6 months postoperatively, the patient will receive the questionnaire surveys to fill out (digitally or by mail) and will be contacted by the research team (digitally or by phone) for follow-up and to answer any questions regarding the study. 12 months At 12 months postoperatively, the patient will attend a standard care follow-up visit with the clinical team, who will perform an anorectal manometry if possible. They will receive the questionnaire surveys to fill out (digitally, by mail or in person) and will be contacted by the research team (digitally, by phone or in person) for follow-up and to answer any questions regarding the study. The trial does not require any additional investigation or patient contact throughout its duration. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | To assess the stress response after rectal cancer surgery and the assessment of sexual, urological and bowel function after rectal cancer surgery.This will be based on 2 primary outcome measurements. 1. Measurement of the stress response by taking blood samples at baseline and on postoperative days 1, 3 and 5: 1.1. White cell count 1.2. CRP 1.3. NLR (neutrophil lymphocyte ratio) 1.4. IL-6 1.5. IL-10 1.6. TNFa 1.7. MPO (neutrophil myeloperoxidase) 2. Functional assessment of sexual, urological and bowel function with the use of validated questionnaires at 12 months: 2.1. International Prostatic Symptoms Score (IPSS) (male) 2.2. International Index of Erectile Function (IIEF) (male) 2.3. Female Sexual Function Index (FSFI) (female) 2.4. Kings Health Questionnaire (KH) (female) 2.5. LARS-score (male/female) 2.6. Vaizey score (male/female) |
| Secondary outcome measures | 1. Quality of life assessment using validated questionnaires (EORTC QLQ-C30/ CR29 and EQ-5D) at baseline, after 6 months and after 12 months. 2. Surgical outcomes, such as operative time, blood loss, stoma application, conversion, and intra-operative complications 3. Patient-related outcomes at 12 months measured using patient records: 3.1. Length of hospital stay 3.2. Opioid requirements and compliance with ERP 3.3. Worst vital signs post op 3.4. Worst pain scores 3.5. Time to flatus (in days) and return of bowel function 3.6. Early morbidity (up to 30-day postoperative complications, Clavien-Dindo Classification) 3.7. Early mortality 3.8. Adverse events. 4. Optional: assessment of anorectal physiology after laparoscopic or robotic surgery in rectal cancer patients by using an anorectal manometry at baseline and after 1 year(Assessment will be done in the outpatient clinic when patients come for their standard care preoperative and 12-month follow-up visit. The manometry will be performed by the clinical team using departmental equipment.) |
| Overall study start date | 22/10/2021 |
| Completion date | 01/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 80 |
| Key inclusion criteria | 1. Age 18 years or above. 2. Diagnosed with rectal cancer, up to 15cm from the anal verge. 3. Local MDT recommends rectal cancer surgery (i.e. (high) anterior resection, partial TME, complete TME) 4. Patient assessed as fit for surgery (ASA I-III). 5. Patient willing and able to give informed consent for participation in the study. 6. Elective surgery. |
| Key exclusion criteria | 1. Patient planned for Abdominoperineal Excision of Rectum (APER) or Hartmann’s procedure 2. Patients with confirmed or suspected metastatic disease. 3. Pregnant or breastfeeding patients. 4. Previous pelvic radiation for other cancers. 5. Inflammatory bowel disease (IBD). 6. Other known auto-immune disease which might influence the immune response (such as advanced liver disease, human immunodeficiency virus infection, Hepatitis B or C virus). 7. Use of anti-inflammatory medication (i.e. corticosteroids, anti-inflammatory drugs, immune modulating drugs, chronic use of antibiotics (the use of NSAIDS and steroid asthma inhalers will not be considered an exclusion criteria). 8. High pre-operative C-reactive protein (CRP) levels (>20). |
| Date of first enrolment | 20/04/2022 |
| Date of final enrolment | 01/02/2024 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Hospital/treatment centre
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
| Phone | +44 2392286000 |
|---|---|
| Sharon.McCready@porthosp.nhs.uk | |
| Website | http://www.porthosp.nhs.uk/ |
"ROR" |
https://ror.org/009fk3b63 |
Funders
Funder type
Research organisation
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BASO~Association of Cancer Surgery, BASO~ACS
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.4 | 06/05/2022 | 27/06/2022 | No | Yes |
| Protocol file | version 4.1 | 16/06/2022 | 27/06/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
12/05/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
