An interventional study of Fluorescence angiography with indocianyne green in Rectal Cancer and Sigmoid Cancer, sponsored by State Scientific Centre of Coloproctology, Russian Federation. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by State Scientific Centre of Coloproctology, Russian Federation · Not applicable, Interventional, and Treatment
This is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.
The design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. After surgery on 7-8 POD patients are examined to two sides X-Ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a Foley catheter for diagnosis of anastomotic leakage.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's enrollment of 377 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →State Scientific Centre of Coloproctology, Russian Federation is the lead sponsor of 26 studies on the registry; 6 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice with the addition of intraoperative imaging using fluorescence angiography with indocianyne green to assess colon and rectal tissue perfusion.
Device: Fluorescence angiography with indocianyne green
A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice.
The fluorescence angiography was performed after mobilization of the bowel, transection of the rectum, division of the rectal and colon mesentery and central vessels, before specimen extraction or resection and creation of the anastomosis. This site was selected by the surgeon using his or her best judgment and typical standard of care assessment. After this selection, the anesthesiologist administered a bolus of 1 to 2 ml indocianyne green intravenously. Perfusion of the colon was visualized and assessed via fluorescence angiography and the line of demarcation between perfused and nonperfused tissue was noted and compared with the initial planned transection point.
Anastomotic Leak Rate
Time frame: 0 to 30 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Aug 2019, 21 months.
Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's 21 months is below that.
Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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State Scientific Centre of Coloproctology, Russian Federation