DISCOVERY

• Research type

  Research Study

• Full title

  DetermIning the role of the microbiome in the development of anaStomotiC leak after anterior resection: a prOspectiVE obseRvational studY (DISCOVERY)

• IRAS ID

  347697

• Contact name

  Jean Uniacke

• Contact email

  governance-ethics@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  2 years, 6 months, 1 days

• Research summary

  Background:
  Anastomotic leak is a life-threatening surgical complication that occurs when the two ends of bowel anastomosis fail to heal, causing spillage of bowel contents into the abdomen. Recent research suggests that certain bacteria present within stool (the microbiome) might increase the risk of anastomotic leak by causing the join in the bowel to break down. However, most of this research has been conducted in the laboratory setting and using animal models, with limited human patient data to support these findings. Understanding the role of the microbiome in this context could be crucial in preventing such life-threatening complications after rectal cancer surgery in the future.

  Aims:
  This study aims to provide important information about the microbiome of patients undergoing rectal cancer surgery, and whether certain features of the microbiome are associated with an increased risk of anastomotic leak. Additionally, the study seeks to assess how current treatments, such as bowel preparation, affect the microbiome.

  Methods:
  Patients undergoing anterior resection for cancer of the rectum or sigmoid colon will be invited to participate.

  Bacterial samples will be collected using swabs from the back passage at three different time points:
  - Pre-operative sample – Collected before bowel preparation is administered.
  - Day of surgery sample – Collected at any time on the day of surgery.
  - Post-operative sample – Collected on post-operative day 3, 4 or 5.

  In addition, participants will be invited to provide a faecal sample via a FIT-style home kit approximately 2-3 months after surgery.

  All participants will be followed up for 90 days after surgery, during which any post-operative complications, including anastomotic leak, will be collected.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  26/NW/0049

• Date of REC Opinion

  25 Feb 2026

• REC opinion

  Favourable Opinion