Anastomotic LeakNCT07906704
Intra-Operative Infrared Thermography for Bowel Resection
A study testing Intra-operative Infrared Thermography and Conventional visual assessment in people with Anastomotic Leak and Bowel Resection, run by Sir Ganga Ram Hospital at 1 site in India.
Trial summary
This prospective randomized control pilot study evaluates the use of intra-operative infrared thermography compared to conventional visual assessment for preventing anastomotic leaks in bowel resection surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Bowel Resection, Intestinal Ischemia
- What is being tested?
- Intra-operative Infrared Thermography and Conventional visual assessment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 18 Jan 2024to 30 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Adult patients undergoing elective single bowel resection and primary anastomosis of the small or large intestine.
Who cannot join
- Patients for whom multiple resections and anastomoses were planned (e.g., colonic pull-up, Roux-en-Y configurations).
- Construction of surgical pouches (e.g., Ileal Pouch-Anal Anastomosis).
- Patients who did not provide informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
About this study
Official title: Utility of Intra-Operative Infrared Thermography in Decision Making for Bowel Resection: A Prospective Randomized Pilot Study
This prospective randomized control pilot study evaluates the use of intra-operative infrared thermography compared to conventional visual assessment for preventing anastomotic leaks in bowel resection surgeries. Eighty adult patients undergoing elective single bowel resection and anastomosis were randomly divided into two equal groups. In the intervention group, a portable thermal camera was used to assess real-time blood supply at the bowel margins to decide the exact line of resection. In the control group, surgeons used standard clinical judgment based on visual cues. The primary outcome measured was the incidence of anastomotic leak within thirty days after surgery. Secondary outcomes evaluated included total operative time, intra-operative blood loss, length of hospital stay, thirty-day mortality, and post-operative complications graded by the Clavien-Dindo classification system.
- Conditions
- Anastomotic Leak, Bowel Resection, Intestinal Ischemia
- Being tested
- Intra-operative Infrared Thermography, Conventional visual assessment
- Keywords
- Infrared Thermography, Bowel Perfusion, FLIR, Colorectal 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 Infrared ThermographyDevice
Use of a passive FLIR thermal camera to map surface temperatures and demarcate perfused from ischemic bowel segments
Conventional visual assessmentProcedure or surgery
Standard surgical assessment utilizing visual and tactile cues such as serosal color, palpable mesenteric pulsations, and active bleeding
| Study group | Role | What they receive |
|---|---|---|
| IRT Group | Experimental | Real-time perfusion evaluation using a portable thermal camera to determine the resection line Receives: Device: Intra-operative Infrared Thermography |
| Control Group | Active comparator | Adequacy of perfusion assessed exclusively through the surgeon's standard clinical judgment Receives: Procedure: Conventional visual assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leak
Incidence of clinically or radiologically confirmed anastomotic leak.
Measured: From date of surgery until hospital discharge, assessed up to 30 days
Secondary outcomes (4)
Operative Time
Total duration of the surgery from skin incision to closure
Measured: Intra-operative
Length of Hospital Stay
Total days admitted in the hospital
Measured: Day of surgery to discharge
Postoperative Complications
Evaluated using the Clavien-Dindo classification system
Measured: Within 30 days postoperatively
Mortality
Incidence of death
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start18 Jan 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vidit Dholakia, Sir Ganga Ram Hospital
- Investigators
- Vidit A Dholakia, MS,DrNB, Principal investigator, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906704
- Sponsor's protocol ID
- EC/NEW/INST/2022/DL/0124
- Other IDs
- REF/2026/05/131213
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Intra-Operative Infrared Thermography in Decision Making for Bowel Resection: A Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT07906704
- Acronym / sponsor ID
- EC/NEW/INST/2022/DL/0124
- Conditions
- Anastomotic Leak, Bowel Resection, Intestinal Ischemia
- Keywords
- Infrared Thermography, Bowel Perfusion, FLIR, Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 30 Oct 2026 (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.
This prospective randomized control pilot study evaluates the use of intra-operative infrared thermography compared to conventional visual assessment for preventing anastomotic leaks in bowel resection surgeries. Eighty adult patients undergoing elective single bowel resection and anastomosis were randomly divided into two equal groups. In the intervention group, a portable thermal camera was used to assess real-time blood supply at the bowel margins to decide the exact line of resection. In the control group, surgeons used standard clinical judgment based on visual cues. The primary outcome measured was the incidence of anastomotic leak within thirty days after surgery. Secondary outcomes evaluated included total operative time, intra-operative blood loss, length of hospital stay, thirty-day mortality, and post-operative complications graded by the Clavien-Dindo classification system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRT Group | Experimental | Device: Intra-operative Infrared ThermographyReal-time perfusion evaluation using a portable thermal camera to determine the resection line |
| Control Group | Active comparator | Procedure: Conventional visual assessmentAdequacy of perfusion assessed exclusively through the surgeon's standard clinical judgment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Adult patients undergoing elective single bowel resection and primary anastomosis of the small or large intestine.
Key exclusion criteria (3 listed)
- Patients for whom multiple resections and anastomoses were planned (e.g., colonic pull-up, Roux-en-Y configurations).
- Construction of surgical pouches (e.g., Ileal Pouch-Anal Anastomosis).
- Patients who did not provide informed consent
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 Infrared ThermographyUse of a passive FLIR thermal camera to map surface temperatures and demarcate perfused from ischemic bowel segments | Device | IRT Group |
| Conventional visual assessmentStandard surgical assessment utilizing visual and tactile cues such as serosal color, palpable mesenteric pulsations, and active bleeding | Procedure or surgery | Control Group |
Primary outcome
Anastomotic Leak
Time frame: From date of surgery until hospital discharge, assessed up to 30 days
Incidence of clinically or radiologically confirmed anastomotic leak.
4 secondary outcomes
Operative Time
Time frame: Intra-operative
Length of Hospital Stay
Time frame: Day of surgery to discharge
Postoperative Complications
Time frame: Within 30 days postoperatively
Mortality
Time frame: Within 30 days postoperatively
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Vidit A Dholakia, MS,DrNB principal investigator
Sir Ganga Ram 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 Infrared Thermography and Conventional visual assessment in people with Anastomotic Leak and Bowel Resection, 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?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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 30 Oct 2026. 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: From date of surgery until hospital discharge, assessed up to 30 days). 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 30 Oct 2026.