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 | Completed DMC

• 1 other identifier: COLORECTAL IRT 40
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Infra-red thermography; Anastomotic leak; Colo-rectal Surgery

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak

  Anastomotic leak detected clinically or radiologically

  8 weeks

Secondary Outcomes (2)

• Clavien Dindo Complication grade

  8 weeks

• Hospital stay

  8 weeks

Other Outcomes (2)

• Mortality

  30 day

• Operative time and blood loss

  1 day

Study Arms (2)

Intra-operative Infra-red thermography

EXPERIMENTAL

. 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.

Other: Intra-operative Infra-red thermography

Conventional without Infra-red thermography

NO INTERVENTION

Resection margin determined by conventional visual and palpatory method

Interventions

Intra-operative Infra-red thermography OTHER

. 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.

Intra-operative Infra-red thermography

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Gangaram Hospital

Delhi, 110060, India

Location

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Barun Kumar Singh, MS

  Sir Gangaram Hospital

  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: Senior resident

Model Details: . 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.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: August 9, 2021
• Primary Completion: November 22, 2022
• Study Completion: December 28, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

IN (1)