Clinical outcomes from robotic colorectal surgery in England: a national study using routinely collected data

Date of Approval
Application Number
21_000572
Technical Summary

Background: Robotically-assisted colorectal surgery has expanded in the last decade since first reported in 2002. Previous Randomised-Controlled Trials and Systematic Reviews have demonstrated equivalent oncological outcomes, compared to laparoscopic surgery, with possibly decreased length of stay and conversion to open surgery. However, these studies were based solely off data from the United States, with no data from England. No studies have been done in England comparing the outcomes of patients undergoing robotically-assisted versus laparoscopic surgery.

Objectives:
• To quantify the uptake of robotic colorectal surgery by year and geographical region in England.
• To compare 30 and 90 day mortality, length of stay, readmission rates, stoma formation and venous thromboembolism (VTE) in robotic versus laparoscopic colorectal surgery in England

Design: This will be a retrospective historical cohort study of patients undergoing elective colorectal surgery from 2002 to 2020. Patients will be identified using the relevant Office of Population Censuses and Surveys codes for colectomy from HES data for this period. Geographical region, socio-economic status and year will be defined from HES data. 30/90 day mortality will be defined from the Office of National Statistics data, with length of stay, readmission, stoma formation and VTE rates from linked HES and CPRD Aurum data.

Means will be used for parametric data, medians for non-parametric data and percentages for categorical variables. Analysis will be done with relevant parametric or non-parametric tests, for example the Mann-Whitney U test for length of stay, assuming non-parametric distribution. VTE rates will be analysed by Cox regression, adjusted for confounders. Crude mortality rates will be calculated and compared using Cox regression analysis.

Outcomes: If we demonstrate that robotic surgery has equivalent or superior outcomes to laparoscopic surgery in England, this would help adoption of this approach. By highlighting regional differences, we hope to minimise future variations in access.

Health Outcomes to be Measured

Primary outcomes: Number and proportion of robotic compared to laparoscopic or open colorectal cases undertaken per year and by region in England; 30 day and 90 day all cause mortality;
Secondary outcomes: length of stay, readmission rates, stoma formation and venous thromboembolism at 30 days in robotic compared to laparoscopic colorectal surgery.

Collaborators

David Humes - Chief Investigator - University of Nottingham
Alastair Morton - Corresponding Applicant - University of Nottingham
Joe West - Collaborator - University of Nottingham

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation