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Endoscopic Visualisation of Anastomosis in Colorectal Cancer Surgery (EVACCS)

Primary Purpose

Rectal Cancer, Colorectal Cancer, Anastomotic Leak

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-operative endoscopy
Sponsored by
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospitals Plymouth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intra-operative endoscopy

Standard air leak test

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2021
Last Updated
February 3, 2021
Sponsor
University of Plymouth
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1. Study Identification

Unique Protocol Identification Number
NCT04738240
Brief Title
Endoscopic Visualisation of Anastomosis in Colorectal Cancer Surgery
Acronym
EVACCS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
April 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Anastomotic leak is one of the biggest challenges in colorectal surgery with little still known about what causes a 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 extra-luminal compartments. Current leak rates following rectal surgery are between 8% and 17%, which is significant given the numbers of resections performed in our unit, approximately 750 per year. The morbidity of an anastomotic leak can be significant. Most require re-operation and those that do not may require interventional radiological drainage or prolonged hospital stay for intra-venous antibiotics. There is also a high risk of mortality, especially for those requiring a further operation where it can be up to 5.8%. The cost of a leak has been shown to be significant both in monetary terms and by increasing the length of stay. In a study from the USA per 1,000 patients undergoing colorectal surgery, the economic burden associated with anastomotic leaks--including hospitalization and re-admission--was established as 9,500 days in prolonged LOS and $28.6 million in additional costs. The investigators plan to perform an intra-operative endoscopy for participants undergoing rectal resection and anastomosis to understand what leads to an anastomotic leak and to try and reduce the rates of anastomotic leakage by fixing these problems at the time of operation so they do not lead to a post-operative complication. In the intervention group during the procedure the investigators will visualise the anastomosis endoscopically looking for defects, areas of ischaemia and congestion. Previous retrospective studies have proven the safety of this technique and significant reduction of leak rates, albeit within the limitations of a retrospective study; the investigators plan to take this hypothesis further to using a randomised approach. 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 taken during the procedure to document the findings. This compares to current standard practice in the control group of air insufflation into the rectum while the anastomosis is bathed in sterile water to look for the presence of air bubbles which may have come through an anastomotic defect. If the test is positive the surgeon makes a decision regarding whether suture re-inforcement, re-do of the anastomosis and/or defunctioning stoma is required. There are no standardised guidelines for this decision making process. This is currently standard practice in most colorectal departments in the UK. The aim of the study is to see if this trial design is feasible within the investigators department and if so to progress to a full scale trial. The secondary aim is from the preliminary data to see if there is a significant difference in anastomotic leak rates between participants who receive standard care and participants who receive our intervention. There are no previous randomised trials into this subject and considering the significance of an anastomotic leak we feel this justifies further research. For patients an anastomotic leak can be catastrophic, both for short and long term outcomes and patients who have had this complication would be very keen for any intervention that may reduce the risk of this happening. It will eliminate a major source of risk for patients, improve quality of life, and produce immediate cost-savings for the NHS. Compared to our current standard practice, which is limited as there is no direct visualisation of the bowel, the investigators feel this new technique will provide significantly more information to make an informed decision on an anastomosis and therefore lead to a reduction in leak rates. The current practice of an air-leak test is standard practice in the UK but a small number of centres have looked at endoscopic visualisation with less rigorous methodology (retrospective/non-randomised studies).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Colorectal Cancer, Anastomotic Leak, Intraoperative Endoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-operative endoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard air leak test
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Intra-operative endoscopy
Intervention Description
Intra-operative endoscopy to assess rectal anastomosis
Primary Outcome Measure Information:
Title
Clinical anastomotic leak
Description
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.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Rossi, MBChB
Organizational Affiliation
University of Plymouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Plymouth
City
Plymouth
State/Province
Devon
ZIP/Postal Code
EX1 2TE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endoscopic Visualisation of Anastomosis in Colorectal Cancer Surgery

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