FILTER
Research type
Research Study
Full title
A prospective cohort study of Functional and Immunological outcomes after Laparoscopic and Robotic Total Meso-rectal Excision for rectal cancer
IRAS ID
310837
Contact name
Jim Khan
Contact email
Sponsor organisation
Portsmouth Hospitals University NHS Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
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.
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.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.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0051
Date of REC Opinion
18 Mar 2022
REC opinion
Further Information Favourable Opinion