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.
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
- Conditions the study is for
- Colo-rectal Surgery, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intra-operative Infra-red thermography |
| Conventional without Infra-red thermography | No intervention | Resection 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.
Anastomotic leak
Anastomotic leak detected clinically or radiologically
Measured: 8 weeks
Secondary outcomes (2)
Clavien Dindo Complication grade
All post-operative complications
Measured: 8 weeks
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.
- First posted22 Dec 2023
- Study start9 Aug 2021
- Primary completion22 Nov 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barun Kumar Singh, Sir Ganga Ram Hospital
- Investigators
- Barun Kumar Singh, MS, Principal investigator, Sir Gangaram Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastomotic Leak Rates in Patients Undergoing Colo-rectal Surgery With or Without Intra-operative Infra-red Thermography: Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06180564
- Acronym / sponsor ID
- COLORECTAL IRT 40
- Keywords
- Infra-red thermography, Anastomotic leak, Colo-rectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intra-operative Infra-red thermography | Experimental | 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. |
| Conventional without Infra-red thermography | No intervention | –Resection margin determined by conventional visual and palpatory method |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intra-operative Infra-red thermography |
Primary outcome
Anastomotic leak
Time frame: 8 weeks
Anastomotic leak detected clinically or radiologically
2 secondary outcomes
Clavien Dindo Complication grade
Time frame: 8 weeks
Hospital stay
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Related trials for Colo-rectal Surgery
Not yet recruiting
NURSE-led Geriatric Assessment in Older Colorectal Cancer Patients
Colo-rectal Cancer
Not yet recruiting
Megagon Magnet Anastomosis Plus OTOLoc for Creating Colo-colonic and Colorectal Anastomoses
Colo-rectal Anastomosis
Recruiting
Prehabilitation in High-risk Oncologic Surgery
Pancreatic Cancer, Colo-rectal Cancer
Not yet recruitingObservational study
Early Discharge After Colorectal Surgery
Cancer, Colo-rectal Cancer
RecruitingPhase 2
A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
Colo-rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barun Kumar Singh, MS principal investigator
Sir Gangaram Hospital
1 site in 1 country: see every site and its status.
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.