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

NCT ID: NCT06180564

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2022-12-28

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.

Detailed Description

A pilot randomised control study was done on adult patients undergoing elective open and lap-assisted colo-rectal surgery with ileo-colic, colo-colic, colo-rectal and colo-anal anastomoses. Patients who did not consent, who were operated in emergency, pouch surgeries and in whom resection and anastomosis was not performed were excluded.

43 patients operated between August' 2021 to November' 2022 were allocated to test and control group by simple randomisation without blinding. In the test group after mesenteric devascularisation, the site of resection was marked by the operating surgeon. After that IRT was performed using Infra-red thermal imaging FLIR C2 portable camera in the video mode and the images seen in rainbow colour display mode. The bowel segments of interest were examined from a distance range of 6 to 12 inches at the standard operation theatre temperature and humidity. Colour mapping and corresponding temperature changes were used to demarcate vascularized and non-vascularized segments of bowel. IRT-guided resection line was assigned to the place where the greatest temperature "jump" was observed (corresponding to a change of >3oC and a sharp change of colour on the screen). The IRT determined resection line was compared with the position of the resection line determined by the surgeon using conventional method. A difference of greater than 1 cm between the IRT and surgeon determined resection line was classified as non-matching and the margin was revised till the difference was less than 1 cm. The process was repeated at proximal and distal resection margins. In the control group the resection line was determined by conventional visual and palpatory method. In both the groups after resection of bowel, anastomosis was done as per surgeon preference. Diverting loop ileostomy was done on surgeon's discretion. Occurrence of an anastomotic leak (AL) up-to 8weeks post-operatively was recorded as the primary outcome. AL was defined as at-least one of the following (i) Anastomotic defect noted on physical examination. (ii) Anastomotic defect confirmed in the operating room. (iii) Anastomotic defect seen on proctoscopy. (iv) Radiologic evidence of a leak consisting of either a defect in the anastomosis and an adjacent fluid collection or stranding or extravasation of rectal contrast into the extraluminal space. (v) Clinical evidence of leak such as feculent output from abdominal/pelvic drain. Operative time, blood loss, length of hospital-stay, 30-day mortality and post-operative complications as per the Clavien-Dindo scale were the secondary outcome measured.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intra-operative Infra-red thermography

Intervention Type: 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.

Conventional without Infra-red thermography

Resection margin determined by conventional visual and palpatory method

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Ganga Ram Hospital

OTHER

Sponsor Role: lead

Responsible Party

Barun Kumar Singh

Senior resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barun Kumar Singh, MS

Role: PRINCIPAL_INVESTIGATOR

Sir Gangaram Hospital

Locations

Sir Gangaram Hospital

Delhi, , India

Countries

India

Other Identifiers

COLORECTAL IRT 40

Identifier Type: -

Identifier Source: org_study_id