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Comparison of Rates of Anastomotic Leak in Patients Undergoing Colo-rectal Surgery When Bowel Perfusion and Resection Margin is Deterimined by Intra-operative Infra-red Thermography or by Conventional Method

NCT06180564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-12-22

No results posted yet for this study

Summary

Pilot RCT with 20 patients in both test and control group. In the control group resection \& anastomosis was done using the conventional method. In the test group after devascularisation the resection line was marked on the bowel wall and IRT done using a forward looking infra- red camera with a rainbow display. Resection line was determined by a sharp change in colour on the display screen (corresponding to \> 30C change in surface temperature) over the visualised bowel wall. Margins were revised if difference between surgeon and IRT determined resection lines were more than 1cm apart. Anastomosis was done as per surgeon's preference.AL was the primary outcome measure. Hospital stay, operative time, blood loss, post-operative complications as per Clavien-Dindo classification were the secondary outcome measures.

Conditions

  • Colo-rectal Surgery
  • Anastomotic Leak Large Intestine
  • Anastomotic Leak Rectum

Interventions

OTHER

Intra-operative Infra-red thermography

. In the test group after devascularisation of the bowel segment surgeon marked the resection line using their conventional method, then IRT was used to determine the resection line using infra- red camera in rainbow display mode. Resection line was determined by abrupt colour change (corresponds to decrease in temperature \>3 degree Celsius) over the visualised bowel wall. Margins were revised if difference between surgeon and IRT determined resection lines were more than 1cm apart.

Sponsors & Collaborators

  • Sir Ganga Ram Hospital

    lead OTHER

Principal Investigators

  • Barun Kumar Singh, MS · Sir Gangaram Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2022-11-22
Completion
2022-12-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180564 on ClinicalTrials.gov