Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
NCT ID: NCT04012645
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
547 participants
INTERVENTIONAL
2023-11-16
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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experimental group
Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.
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.
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
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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）;
Exclusion Criteria
* Patients with intestinal obstruction, intestinal perforation, intestinal bleeding who need emergency operation;
* Patients requiring combined organ resection that the tumor involves adjacent organs;
* Patients with recurrence of tumor or distant metastasis;
* Patients with multiple colorectal cancer;
* Patients with history of inflammatory bowel disease or familial adenomatous polyposis;
* Patients who have participated in or are participating in other clinical trials in the past four weeks;
* Patients that ASA level is larger than III;
* Physical condition: Patients with KPS less than or equal to 60 points or ECOG larger than or equal to 2 points;
* Patients with hepatic dysfunction and MELD larger than 12 points;
* Patients with a history of serious mental illness;
* Pregnant or lactating women;
* Patients who are improper to participate in the study in the opinion of the researchers.
18 Years
80 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Chinese PLA General Hospital
OTHER
Peking University People's Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Beijing Hospital
OTHER_GOV
Changhai Hospital
OTHER
Ruijin Hospital
OTHER
RenJi Hospital
OTHER
Fudan University
OTHER
Guangdong Provincial People's Hospital
OTHER
Southern Medical University, China
OTHER
First Hospital of China Medical University
OTHER
The First Hospital of Jilin University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Fujian Medical University Union Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Zhongtao Zhang
OTHER
Responsible Party
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Zhongtao Zhang
Director of General Surgery of Beijing Friendship Hospital
Principal Investigators
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Zhongtao Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, China
Countries
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Central Contacts
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Facility Contacts
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References
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Sun L, Gao J, Wu G, Meng C, Yang Z, Wei P, Yao H, Zhang Z. Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol. BMJ Open. 2024 May 9;14(5):e079858. doi: 10.1136/bmjopen-2023-079858.
Other Identifiers
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Poster
Identifier Type: -
Identifier Source: org_study_id
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