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Trial · NCT07899125

FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery

NCT07899125, Not applicable, Not yet recruiting, Basavatarakam Indo American Cancer Hospital & Research Institute

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery. Trials, record NCT07899125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07899125

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
NCT number
NCT07899125
Status
Not yet recruiting
Phases
Not applicable
Enrollment
610 participants, estimated
Lead sponsor
Basavatarakam Indo American Cancer Hospital & Research Institute
Conditions
Rectal Cancer Patients, Rectal Cancer Surgery, Colorectal Cancer, Anastomotic Leak Rectum, Anastomotic Leakage in Colon Surgery
Interventions
Indocyanine Green Fluorescence Angiography, Standard Surgical Perfusion Assessment
First posted
2026-10-27
Last updated
2026-10-27

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTotal Anastomotic Leakage RateWithin 30 days after surgery
Incidence of anastomotic leakage of any grade after surgery. Anastomotic leakage will include grade A, grade B, and grade C leaks. Grade A is a radiological leak without symptoms and without need for active treatment. Grade B is a symptomatic leak requiring non-surgical treatment such as antibiotics or drainage. Grade C is a symptomatic leak requiring reoperation.
SecondaryClinically Significant Anastomotic Leakage RateWithin 30 days after surgery
Incidence of clinically significant anastomotic leakage after surgery, defined as grade B or grade C leakage. Grade B leakage is a symptomatic leak requiring non-surgical treatment such as antibiotics, percutaneous drainage, or transanal drainage. Grade C leakage is a symptomatic leak requiring reoperation.
Secondary30-day postoperative morbidityWithin 30 days after surgery
Number and proportion of participants who develop one or more postoperative complications within 30 days after the index surgical procedure. Postoperative complications will be classified according to the Clavien-Dindo classification. Complications occurring during the index hospitalization or after discharge within the 30-day follow-up period will be included.
Secondary30-day postoperative mortalityWithin 30 days after surgery
Number and proportion of participants who die from any cause within 30 days after surgery. This will include deaths occurring during the index hospitalization as well as deaths occurring after discharge but within 30 days of the surgical procedure.
SecondaryRate of intraoperative modification of the proximal bowel transection line after ICG assessment.During surgery, after ICG-FA assessment and before construction of the anastomosis
Number and proportion of participants in the ICG-FA group in whom the initially planned proximal bowel transection line is changed after intraoperative ICG fluorescence assessment because of inadequate perfusion. Any modification of the planned proximal transection line following ICG-FA assessment will be recorded.
SecondaryRate of Intraoperative Modification of the Distal Rectal Stump Transection Line After ICG-FA AssessmentDuring surgery, after ICG-FA assessment and before construction of the anastomosis
Number and proportion of participants in the ICG-FA group in whom the initially planned distal rectal stump transection line is changed after intraoperative ICG fluorescence assessment because of inadequate perfusion. Any modification of the planned distal transection line following ICG-FA assessment will be recorded.
SecondaryTime to Fluorescence Appearance After ICG AdministrationDuring surgery, following ICG administration and before construction of the anastomosis
Time, measured in seconds, from intravenous administration of indocyanine green to the first visible appearance of fluorescence at the planned anastomotic site. Fluorescence appearance time will be recorded separately for the proximal large bowel end and the distal rectal stump in participants assigned to the ICG-FA group.
SecondaryOperative TimeDuring surgery
Total duration of the surgical procedure, measured in minutes from skin incision to completion of skin closure. Operative time will be recorded for participants in both the ICG-FA group and the control group and compared between groups.
Secondary30-Day Reoperation RateWithin 30 days after surgery
Number and proportion of participants who require an unplanned surgical reoperation for any postoperative complication within 30 days after the index surgical procedure. Reoperations occurring during the initial hospital admission or after discharge within the 30-day follow-up period will be included. Planned procedures, including elective stoma closure, will not be considered reoperations for this outcome.
SecondaryLength of Postoperative Hospital StayFrom surgery until hospital discharge
Duration of postoperative hospitalization, measured in days from the date of the index surgical procedure to the date of hospital discharge. Length of stay will be recorded for participants in both the ICG-FA group and the control group and compared between groups.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
32189424BACKGROUNDPubMed
33872284BACKGROUNDPubMed
37218517BACKGROUNDPubMed
39151436BACKGROUNDPubMed
40690925BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07899125

GET https://conductscience.org/api/trials/v1/NCT07899125/registered