NCT04012645

Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR

A Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 547 (estimated)
• Sponsor: Zhongtao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

It is a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery aims to explore whether the application of near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.

Detailed description

In total mesorectal excision of rectal cancer, accurate assessment of rectal anastomotic blood supply is crucial: for insufficient anastomotic blood supply is an important cause of postoperative anastomotic leakage, and once anastomotic leakage occurs, the perioperative mortality rate of patients is reportedly 16%. In the past, the assessment of anastomotic blood supply mainly depended on the experience of the surgeon and lacked objective and accurate assessment methods. In recent years, the application of near-infrared fluorescence laparoscopic imaging technology has provided a new way to accurately evaluate anastomotic perfusion. At present, the technology has been applied to evaluate anastomotic blood supply in colorectal cancer surgery worldwide, and its safety and reliability have been confirmed. However, whether the application of this technology can reduce the incidence of anastomotic leakage after total mesorectal excision for rectal cancer and thus benefit patients still needs high-level evidence-based medical evidence support with multi-centers and large samples.Thus, a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery was intend to conduct to explore whether the application of near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.

Conditions

• Rectal Neoplasms

Interventions

Type	Name	Description
PROCEDURE	application of near infrared-indocyanine green imaging system	Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used to evaluate the anastomotic flood perfusion during the operation; The operator may decide whether to change the surgical programme based on the outcome of the evaluation.
PROCEDURE	Non-application of near infrared-indocyanine green imaging system	Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience

Timeline

• Start date: 2023-11-16
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-07-09
• Last updated: 2023-11-18

Locations

2 sites across 1 country: China