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Colo-rectal SurgeryNCT06180564

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

A study testing Intra-operative Infra-red thermography in people with Colo-rectal Surgery and Anastomotic Leak Large Intestine, run by Sir Ganga Ram Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Intra-operative Infra-red thermography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteIndia
Study dates
9 Aug 2021to 28 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Elective colo-rectal surgery, Laparoscopy assisted/ Open , Resection anastomosis done -

Exclusion Criteria: Emergency, Pouch surgery, Consent refusal, No resection \& anastomosis

-

Trial locations and contacts

1 site in 1 country.

India1 site
  • Sir Gangaram Hospital

    Delhi, 110060

Other trials in India

About this study

Official title: Anastomotic Leak Rates in Patients Undergoing Colo-rectal Surgery With or Without Intra-operative Infra-red Thermography: Pilot Randomized Controlled Study

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.

Read the 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.

Being tested
Intra-operative Infra-red thermography
Keywords
Infra-red thermography, Anastomotic leak, Colo-rectal Surgery
Medical subject headings
Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-operative Infra-red thermographyOther

    . 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 groups in NCT06180564
Study groupRoleWhat they receive
Intra-operative Infra-red thermographyExperimental. 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.
Receives: Other: Intra-operative Infra-red thermography
Conventional without Infra-red thermographyNo interventionResection margin determined by conventional visual and palpatory method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anastomotic leak

    Anastomotic leak detected clinically or radiologically

    Measured: 8 weeks

Secondary outcomes (2)
  1. Clavien Dindo Complication grade

    All post-operative complications

    Measured: 8 weeks

  2. Hospital stay

    From the time of surgery to discharge

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2023
  2. Study start9 Aug 2021
  3. Primary completion22 Nov 2022
  4. Study completion28 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
. 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.
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180564
Sponsor's protocol ID
COLORECTAL IRT 40
Status last verified
Dec 2023
First submitted
12 Dec 2023
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Intra-operative Infra-red thermography in people with Colo-rectal Surgery and Anastomotic Leak Large Intestine, run by Sir Ganga Ram Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anastomotic leak (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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