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

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.

Conditions

• Rectal Neoplasms

Interventions

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

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Changhai Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Zhongtao Zhang

  lead OTHER

Principal Investigators

• Zhongtao Zhang, Professor · Beijing Friendship Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-16

Primary Completion

2023-12-01

Completion

2023-12-01

Countries

• China

Study Locations