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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• The age was over 18 years at the time of diagnosis;

• Diagnosis of rectal carcinoma and was confirmed by preoperative pathology;

• MRI was performed before operation, and the distance between the lower margin of tumor and the anal margin was no more than 10cm;

• The colon-rectum or colon-anus anastomosis was performed by laparoscopic TME operation

• The spleen area was not free during the operation

• Baseline clinical tumor stage TNM Ⅰ-Ⅲ phase: cT1-4N0-2M0 (AJCC-8 version);

Locations
Other Locations
China
Beijing Friendship Hospital
RECRUITING
Beijing
Beijing Friendship Hospital, Capital medical University
RECRUITING
Beijing
Contact Information
Primary
Zhongtao Zhang, Professor
zhangzht@medmail.com.cn
13801060364
Backup
Hongwei Yao, Professor
yaohongwei@medmail.com.cn
13611015609
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2023-12-01
Participants
Target number of participants: 547
Treatments
Experimental: experimental group
Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.
Active_comparator: control group
Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience
Related Therapeutic Areas
Sponsors
Collaborators: Peking Union Medical College Hospital, Ruijin Hospital, RenJi Hospital, Southern Medical University, China, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Peking University Cancer Hospital & Institute, Beijing Chao Yang Hospital, Beijing Hospital, The First Affiliated Hospital with Nanjing Medical University, First Hospital of China Medical University, Changhai Hospital, Peking University People's Hospital, First Affiliated Hospital of Chongqing Medical University, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, The First Hospital of Jilin University, Chinese PLA General Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Leads: Zhongtao Zhang

This content was sourced from clinicaltrials.gov