NCT04738240

Brief Summary

A randomised feasibility study into the use of endoscopic visualisation of rectal anastomosis vs. current practice and the effect on anastomotic leak rates in patients undergoing rectal surgery for bowel cancer in a tertiary referral centre

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 28, 2021

Last Update Submit

February 3, 2021

Conditions

Rectal CancerColorectal CancerAnastomotic LeakIntraoperative Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Clinical anastomotic leak

    An anastomotic leak is defined as a defect of the intestinal wall at the anastomotic site leading to a communication between the intra- and extraluminal compartments. If there is clinical suspicion of an anastomotic leak (signs of peritonism on examination, rising inflammatory markers) a CT scan will be performed to confirm.

    60 days

Study Arms (2)

Intra-operative endoscopy

EXPERIMENTAL

The intervention arm will have an intra-operative endoscopy performed per rectum once the anastomosis has been performed. The anastomosis will be graded from 1 to 3 in the endoscopic group. Grade 1 is defined as circumferentially normal appearing peri-anastomotic mucosa. Grade 2 is defined as ischemia or congestion involving \<30% of either the colon or rectal mucosa. Grade 3 is defined as ischemia or congestion involving \>30% of the colon or rectal mucosa or ischemia/congestion involving both sides of the staple line. If appearances are grade 2 a suture re-inforcement or re-anastomosis will be performed; if appearances are grade 3 a re-anastomosis will be performed. Images will be obtained via the endoscopy stack during the assessment.

Diagnostic Test: Intra-operative endoscopy

Standard air leak test

NO INTERVENTION

The control arm will receive an intra-operative leak test. This involves insufflation of air per rectum via bladder syringe while the anastomosis is bathed in sterile water. The presence of air bubbles from the anastomosis denotes a positive test.

Interventions

Intra-operative endoscopyDIAGNOSTIC_TEST

Intra-operative endoscopy to assess rectal anastomosis

Intra-operative endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Undergoing colorectal resection involving the rectum
  • Able to give informed consent to participate in trial
  • American Society of Anesthesiologists (ASA) grade ≤ 3

You may not qualify if:

  • Patients not undergoing colo-rectal/anal anastomosis e.g. abdominoperineal excision of rectum (APER), Hartmann's procedure.
  • Patients undergoing synchronous colonic resections.
  • Locally advanced rectal cancer requiring extended or multi-visceral excision.
  • Recurrent rectal cancer
  • Coexistent colorectal pathology e.g. synchronous cancers, inflammatory bowel disease.
  • Previous pelvic radiotherapy for pathology unrelated to diagnosis with rectal cancer e.g. treatment for prostate cancer
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Plymouth

Plymouth, Devon, EX1 2TE, United Kingdom

Location

MeSH Terms

Conditions

Rectal NeoplasmsColorectal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin Rossi, MBChB

    University of Plymouth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 4, 2021

Study Start

March 11, 2019

Primary Completion

March 11, 2020

Study Completion

April 25, 2020

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)