Clinical trial · Interventional
Endoscopic Visualisation of Anastomosis in Colorectal Cancer Surgery
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
NCT04738240CI-TRIAL-00049867EVACCScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Intraoperative Endoscopy | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative endoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intra-operative endoscopy
- 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.
- interventionNames
- Diagnostic Test: Intra-operative endoscopy
- type
- NO_INTERVENTION
- label
- Standard air leak test
- 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.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.