Rectal Cancer PatientsFLARENCT07899125
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
A study testing Indocyanine Green Fluorescence Angiography and Standard Surgical Perfusion Assessment in people with Rectal Cancer Patients and Rectal Cancer Surgery, run by Basavatarakam Indo American Cancer Hospital & Research Institute at 1 site in India.
Trial summary
The goal of this clinical trial is to find out whether using a special green dye called indocyanine green (ICG) during minimally invasive rectal cancer surgery can help surgeons assess blood flow to the bowel and reduce leakage from the surgical connection between two ends of the bowel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Patients, Rectal Cancer Surgery, Colorectal Cancer
- What is being tested?
- Indocyanine Green Fluorescence Angiography and Standard Surgical Perfusion Assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, inclusive.
- Histologically confirmed rectal adenocarcinoma, treated with or without neoadjuvant therapy.
- Planned minimally invasive anterior rectal resection (laparoscopic or robotic) with anastomosis 2-15 cm from the anal verge, below the peritoneal reflection.
- Planned colorectal or coloanal anastomosis.
- Ability to provide written informed consent.
Who cannot join
- Emergency surgery or palliative procedure.
- Known allergy or hypersensitivity to indocyanine green (ICG) or iodine.
- Pregnancy or lactation.
- Severe renal or hepatic failure.
- Any serious contraindication to minimally invasive surgery.
- Planned open rectal surgery.
Show all 9Show fewer
- Conversion from minimally invasive surgery to open surgery before randomization.
- Intraoperative discovery of unresectable disease before randomization.
- Inability to construct the planned colorectal or coloanal anastomosis before randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc) contact
India1 site
Basavatarakam Indo American Cancer Hospital and Research Institute
Hyderabad, Telangana, 500034
Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc), 91 9030747486, dr.nusrath2008@gmail.com; drnusrath@basavatarakam.org
Sujit C Patnaik, MS, +91 99127 66228, drsujit888@gmail.com
About this study
Official title: Fluorescent Angiography in Reduction of Anastomotic Leak in Rectal Cancer Surgery
The goal of this clinical trial is to find out whether using a special green dye called indocyanine green (ICG) during minimally invasive rectal cancer surgery can help surgeons assess blood flow to the bowel and reduce leakage from the surgical connection between two ends of the bowel.
The main questions this study aims to answer are:
Read more
- Does using ICG fluorescence imaging reduce the risk of leakage from the bowel connection after surgery?
- Does ICG imaging help surgeons identify areas of the bowel with poor blood flow and decide whether the planned bowel connection needs to be changed?
Researchers will compare ICG fluorescence-guided assessment with conventional visual assessment of bowel blood flow during rectal cancer surgery.
Participants will:
- Undergo planned minimally invasive rectal cancer surgery as part of their treatment.
- Be randomly assigned during surgery to either the ICG fluorescence imaging group or the standard care group.
- Undergo postoperative imaging to check the bowel connection, usually around postoperative day 5 and approximately 4 weeks after surgery.
- Be monitored for postoperative complications during their hospital stay and for 30 days after surgery.
- Attend a follow-up assessment approximately 30 days after surgery.
Read the detailed description
Anastomotic leakage is a significant complication following rectal cancer surgery. Inadequate blood supply to the bowel ends may contribute to poor anastomotic healing, resulting in postoperative complications and prolonged hospitalization.
Conventional intraoperative assessment of bowel perfusion relies on visual examination of bowel color, bleeding from the cut edges, and pulsation of mesenteric vessels. However, these methods are subjective and may not reliably identify areas of inadequate perfusion.
Indocyanine green fluorescence angiography (ICG-FA) enables real-time visualization of tissue perfusion using near-infrared imaging following intravenous administration of ICG. This technique may help surgeons identify poorly perfused bowel segments before construction of the anastomosis. Previous randomized controlled trials have reported conflicting findings regarding its effectiveness in preventing anastomotic leakage, and evidence from Indian surgical populations remains limited.
The FLARE study is a prospective, randomized, open-label, parallel-group trial comparing ICG fluorescence-guided perfusion assessment with conventional visual assessment during minimally invasive rectal cancer surgery.
In the ICG group, fluorescence imaging will be performed before construction of the anastomosis to assess perfusion at both the proximal large bowel end and the distal rectal stump. If inadequate perfusion is identified, the surgeon may modify the planned bowel transection line to select a better-perfused segment.
In the control group, bowel perfusion will be assessed using conventional visual methods without ICG fluorescence imaging. Both groups will undergo standard rectal cancer surgery and postoperative care.
The study will evaluate whether fluorescence-guided perfusion assessment provides additional clinical benefit compared with conventional visual assessment.
- Conditions
- Rectal Cancer Patients, Rectal Cancer Surgery, Colorectal Cancer, Anastomotic Leak Rectum, Anastomotic Leakage in Colon Surgery
- Being tested
- Indocyanine Green Fluorescence Angiography, Standard Surgical Perfusion Assessment
- Keywords
- indocyanine green, ICG Fluorescence, Fluorescence Angiography, Anastomotic Leak, Colorectal Surgery, Bowel Anastomosis, Perfusion Assessment
- Medical subject headings
- Colorectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green Fluorescence AngiographyDiagnostic test
Indocyanine green will be administered intravenously during surgery. Near-infrared fluorescence imaging will be used to assess bowel blood flow at the planned bowel joining site both for proximal large bowel end and distal rectal stump. The surgeon may change the bowel transection level if fluorescence suggests poor blood flow.
Standard Surgical Perfusion AssessmentDiagnostic test
Bowel blood flow will be assessed using standard surgical judgment, including bowel color, bleeding from the cut edge, arterial pulsation, and overall tissue appearance.
| Study group | Role | What they receive |
|---|---|---|
| ICG Fluorescence Angiography Group | Experimental | Participants in this group will undergo planned colorectal cancer surgery with standard surgical assessment of bowel blood flow plus indocyanine green fluorescence angiography. Indocyanine green will be given intravenously during surgery, and near-infrared imaging will be used to assess blood flow at the planned bowel joining site. The surgeon may change the bowel transection level if fluorescence suggests poor blood flow. Receives: Diagnostic Test: Indocyanine Green Fluorescence Angiography; Diagnostic Test: Standard Surgical Perfusion Assessment |
| Control Group | Active comparator | Participants in this group will undergo planned colorectal cancer surgery with standard surgical assessment of bowel blood flow. The surgeon will assess bowel perfusion using usual clinical methods such as bowel color, bleeding from the cut edge, arterial pulsation, and overall tissue appearance. Indocyanine green fluorescence angiography will not be used. Receives: Diagnostic Test: Standard Surgical Perfusion Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Anastomotic Leakage Rate
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.
Measured: Within 30 days after surgery
Secondary outcomes (9)
Clinically Significant Anastomotic Leakage Rate
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.
Measured: Within 30 days after surgery
30-day postoperative morbidity
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.
Measured: Within 30 days after surgery
30-day postoperative mortality
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.
Measured: Within 30 days after surgery
Rate of intraoperative modification of the proximal bowel transection line after ICG assessment.
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.
Measured: During surgery, after ICG-FA assessment and before construction of the anastomosis
Rate of Intraoperative Modification of the Distal Rectal Stump Transection Line After ICG-FA Assessment
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.
Measured: During surgery, after ICG-FA assessment and before construction of the anastomosis
Time to Fluorescence Appearance After ICG Administration
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.
Measured: During surgery, following ICG administration and before construction of the anastomosis
Operative Time
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.
Measured: During surgery
30-Day Reoperation Rate
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.
Measured: Within 30 days after surgery
Length of Postoperative Hospital Stay
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.
Measured: From surgery until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer PatientsStudies 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
- This is a randomized, parallel-group clinical trial in which participants will be assigned in a 1:1 ratio to either the ICG-FA group or the control group. In the ICG-FA group, bowel perfusion will be assessed intraoperatively using indocyanine green fluorescence angiography in addition to standard surgical assessment. In the control group, bowel perfusion will be assessed using standard surgical assessment alone, without fluorescence imaging. The clinical and operative outcomes of the two groups will be compared.
- Masking
- None (open label)
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basavatarakam Indo American Cancer Hospital & Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Nusrath, Basavatarakam Indo American Cancer Hospital & Research Institute
- Investigators
- Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc), Principal investigator, Basavatarakam Indo American Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899125
- Sponsor's protocol ID
- IEC/2025/AC/72
- Other IDs
- CTRI/2026/04/109238
- Acronym
- FLARE
- Status last verified
- Oct 2026
- First submitted
- 1 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the study involves surgical patients and contains sensitive clinical information. Public sharing may risk participant privacy and confidentiality, even after de-identification. De-identified aggregate study results will be reported in publications and trial registry results, as required.
Publications
Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
PubMed 39151436Jayne D, Croft J, Corrigan N, Quirke P, Cahill RA, Ainsworth G, Meads DM, Kirby A, Tolan D, Gordon K, Hompes R, Spinelli A, Foppa C, Wolthuis AM, D'Hoore A, Vignali A, Tilney HS, Moriarty C, Vargas-Palacios A, Young C, Kelly R, Stocken D; IntAct Collaborative Group. Intraoperative fluorescence angiography with indocyanine green to prevent anastomotic leak in rectal cancer surgery (IntAct): an unblinded randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Sep;10(9):806-817. doi: 10.1016/S2468-1253(25)00101-3. Epub 2025 Jul 18.
PubMed 40690925Watanabe J, Takemasa I, Kotake M, Noura S, Kimura K, Suwa H, Tei M, Takano Y, Munakata K, Matoba S, Yamagishi S, Yasui M, Kato T, Ishibe A, Shiozawa M, Ishii Y, Yabuno T, Nitta T, Saito S, Saigusa Y, Watanabe M; EssentiAL Trial Group. Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial. Ann Surg. 2023 Oct 1;278(4):e688-e694. doi: 10.1097/SLA.0000000000005907. Epub 2023 May 23.
PubMed 37218517Jafari MD, Pigazzi A, McLemore EC, Mutch MG, Haas E, Rasheid SH, Wait AD, Paquette IM, Bardakcioglu O, Safar B, Landmann RG, Varma MG, Maron DJ, Martz J, Bauer JJ, George VV, Fleshman JW Jr, Steele SR, Stamos MJ. Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection. Dis Colon Rectum. 2021 Aug 1;64(8):995-1002. doi: 10.1097/DCR.0000000000002007.
PubMed 33872284Alekseev M, Rybakov E, Shelygin Y, Chernyshov S, Zarodnyuk I. A study investigating the perfusion of colorectal anastomoses using fluorescence angiography: results of the FLAG randomized trial. Colorectal Dis. 2020 Sep;22(9):1147-1153. doi: 10.1111/codi.15037. Epub 2020 Apr 6.
PubMed 32189424
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescent Angiography in Reduction of Anastomotic Leak in Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07899125
- Acronym / sponsor ID
- FLARE / IEC/2025/AC/72
- Conditions
- Rectal Cancer Patients, Rectal Cancer Surgery, Colorectal Cancer, Anastomotic Leak Rectum, Anastomotic Leakage in Colon Surgery
- Keywords
- indocyanine green, ICG Fluorescence, Fluorescence Angiography, Anastomotic Leak, Colorectal Surgery, Bowel Anastomosis, Perfusion Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Basavatarakam Indo American Cancer Hospital & Research InstituteUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 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.
The goal of this clinical trial is to find out whether using a special green dye called indocyanine green (ICG) during minimally invasive rectal cancer surgery can help surgeons assess blood flow to the bowel and reduce leakage from the surgical connection between two ends of the bowel.
The main questions this study aims to answer are:
- Does using ICG fluorescence imaging reduce the risk of leakage from the bowel connection after surgery?
- Does ICG imaging help surgeons identify areas of the bowel with poor blood flow and decide whether the planned bowel connection needs to be changed?
Researchers will compare ICG fluorescence-guided assessment with conventional visual assessment of bowel blood flow during rectal cancer surgery.
Participants will:
- Undergo planned minimally invasive rectal cancer surgery as part of their treatment.
- Be randomly assigned during surgery to either the ICG fluorescence imaging group or the standard care group.
- Undergo postoperative imaging to check the bowel connection, usually around postoperative day 5 and approximately 4 weeks after surgery.
- Be monitored for postoperative complications during their hospital stay and for 30 days after surgery.
- Attend a follow-up assessment approximately 30 days after surgery.
Detailed description
Anastomotic leakage is a significant complication following rectal cancer surgery. Inadequate blood supply to the bowel ends may contribute to poor anastomotic healing, resulting in postoperative complications and prolonged hospitalization.
Conventional intraoperative assessment of bowel perfusion relies on visual examination of bowel color, bleeding from the cut edges, and pulsation of mesenteric vessels. However, these methods are subjective and may not reliably identify areas of inadequate perfusion.
Indocyanine green fluorescence angiography (ICG-FA) enables real-time visualization of tissue perfusion using near-infrared imaging following intravenous administration of ICG. This technique may help surgeons identify poorly perfused bowel segments before construction of the anastomosis. Previous randomized controlled trials have reported conflicting findings regarding its effectiveness in preventing anastomotic leakage, and evidence from Indian surgical populations remains limited.
The FLARE study is a prospective, randomized, open-label, parallel-group trial comparing ICG fluorescence-guided perfusion assessment with conventional visual assessment during minimally invasive rectal cancer surgery.
In the ICG group, fluorescence imaging will be performed before construction of the anastomosis to assess perfusion at both the proximal large bowel end and the distal rectal stump. If inadequate perfusion is identified, the surgeon may modify the planned bowel transection line to select a better-perfused segment.
In the control group, bowel perfusion will be assessed using conventional visual methods without ICG fluorescence imaging. Both groups will undergo standard rectal cancer surgery and postoperative care.
The study will evaluate whether fluorescence-guided perfusion assessment provides additional clinical benefit compared with conventional visual assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group clinical trial in which participants will be assigned in a 1:1 ratio to either the ICG-FA group or the control group. In the ICG-FA group, bowel perfusion will be assessed intraoperatively using indocyanine green fluorescence angiography in addition to standard surgical assessment. In the control group, bowel perfusion will be assessed using standard surgical assessment alone, without fluorescence imaging. The clinical and operative outcomes of the two groups will be compared.
| Arm | Type | Receives |
|---|---|---|
| ICG Fluorescence Angiography Group | Experimental | Diagnostic Test: Indocyanine Green Fluorescence Angiography, Diagnostic Test: Standard Surgical Perfusion AssessmentParticipants in this group will undergo planned colorectal cancer surgery with standard surgical assessment of bowel blood flow plus indocyanine green fluorescence angiography. Indocyanine green will be given intravenously during surgery, and near-infrared imaging will be used to assess blood flow at the planned bowel joining site. The surgeon may change the bowel transection level if fluorescence suggests poor blood flow. |
| Control Group | Active comparator | Diagnostic Test: Standard Surgical Perfusion AssessmentParticipants in this group will undergo planned colorectal cancer surgery with standard surgical assessment of bowel blood flow. The surgeon will assess bowel perfusion using usual clinical methods such as bowel color, bleeding from the cut edge, arterial pulsation, and overall tissue appearance. Indocyanine green fluorescence angiography will not be used. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 75 years, inclusive.
- Histologically confirmed rectal adenocarcinoma, treated with or without neoadjuvant therapy.
- Planned minimally invasive anterior rectal resection (laparoscopic or robotic) with anastomosis 2-15 cm from the anal verge, below the peritoneal reflection.
- Planned colorectal or coloanal anastomosis.
- Ability to provide written informed consent.
Key exclusion criteria (9 listed)
- Emergency surgery or palliative procedure.
- Known allergy or hypersensitivity to indocyanine green (ICG) or iodine.
- Pregnancy or lactation.
- Severe renal or hepatic failure.
- Any serious contraindication to minimally invasive surgery.
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 |
|---|---|---|
| Indocyanine Green Fluorescence AngiographyIndocyanine green will be administered intravenously during surgery. Near-infrared fluorescence imaging will be used to assess bowel blood flow at the planned bowel joining site both for proximal large bowel end and distal rectal stump. The surgeon may change the bowel transection level if fluorescence suggests poor blood flow. | Diagnostic test | ICG Fluorescence Angiography Group |
| Standard Surgical Perfusion AssessmentBowel blood flow will be assessed using standard surgical judgment, including bowel color, bleeding from the cut edge, arterial pulsation, and overall tissue appearance. | Diagnostic test | Control Group, ICG Fluorescence Angiography Group |
Primary outcome
Total Anastomotic Leakage Rate
Time frame: Within 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.
9 secondary outcomes
Clinically Significant Anastomotic Leakage Rate
Time frame: Within 30 days after surgery
30-day postoperative morbidity
Time frame: Within 30 days after surgery
30-day postoperative mortality
Time frame: Within 30 days after surgery
Rate of intraoperative modification of the proximal bowel transection line after ICG assessment.
Time frame: During surgery, after ICG-FA assessment and before construction of the anastomosis
Rate of Intraoperative Modification of the Distal Rectal Stump Transection Line After ICG-FA Assessment
Time frame: During surgery, after ICG-FA assessment and before construction of the anastomosis
Time to Fluorescence Appearance After ICG Administration
Time frame: During surgery, following ICG administration and before construction of the anastomosis
Operative Time
Time frame: During surgery
30-Day Reoperation Rate
Time frame: Within 30 days after surgery
Length of Postoperative Hospital Stay
Time frame: From surgery until hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 39151436Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
- Background: PubMed 40690925Jayne D, Croft J, Corrigan N, Quirke P, Cahill RA, Ainsworth G, Meads DM, Kirby A, Tolan D, Gordon K, Hompes R, Spinelli A, Foppa C, Wolthuis AM, D'Hoore A, Vignali A, Tilney HS, Moriarty C, Vargas-Palacios A, Young C, Kelly R, Stocken D; IntAct Collaborative Group. Intraoperative fluorescence angiography with indocyanine green to prevent anastomotic leak in rectal cancer surgery (IntAct): an unblinded randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Sep;10(9):806-817. doi: 10.1016/S2468-1253(25)00101-3. Epub 2025 Jul 18.
- Background: PubMed 37218517Watanabe J, Takemasa I, Kotake M, Noura S, Kimura K, Suwa H, Tei M, Takano Y, Munakata K, Matoba S, Yamagishi S, Yasui M, Kato T, Ishibe A, Shiozawa M, Ishii Y, Yabuno T, Nitta T, Saito S, Saigusa Y, Watanabe M; EssentiAL Trial Group. Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial. Ann Surg. 2023 Oct 1;278(4):e688-e694. doi: 10.1097/SLA.0000000000005907. Epub 2023 May 23.
- Background: PubMed 33872284Jafari MD, Pigazzi A, McLemore EC, Mutch MG, Haas E, Rasheid SH, Wait AD, Paquette IM, Bardakcioglu O, Safar B, Landmann RG, Varma MG, Maron DJ, Martz J, Bauer JJ, George VV, Fleshman JW Jr, Steele SR, Stamos MJ. Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection. Dis Colon Rectum. 2021 Aug 1;64(8):995-1002. doi: 10.1097/DCR.0000000000002007.
- Background: PubMed 32189424Alekseev M, Rybakov E, Shelygin Y, Chernyshov S, Zarodnyuk I. A study investigating the perfusion of colorectal anastomoses using fluorescence angiography: results of the FLAG randomized trial. Colorectal Dis. 2020 Sep;22(9):1147-1153. doi: 10.1111/codi.15037. Epub 2020 Apr 6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the study involves surgical patients and contains sensitive clinical information. Public sharing may risk participant privacy and confidentiality, even after de-identification. De-identified aggregate study results will be reported in publications and trial registry results, as required.
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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.
Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc) contact
Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc) principal investigator
Basavatarakam Indo American Hospital and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green Fluorescence Angiography and Standard Surgical Perfusion Assessment in people with Rectal Cancer Patients and Rectal Cancer Surgery, run by Basavatarakam Indo American Cancer Hospital & Research Institute 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Nusrath, MS,DNB(Gen Surg),DNB(Surg Onc) (91 9030747486, dr.nusrath2008@gmail.com; drnusrath@basavatarakam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Anastomotic Leakage Rate (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07899125, which also lists 5 linked publications.
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 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.