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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries. |
|
| control group | Active Comparator | Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| application of near infrared-indocyanine green imaging system | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leakage | Anastomotic leakage occured within 30 days after operation. The diagnostic criteria for AL include: Flow of gas, abscess, or excrement from pelvic drainage tube, surgical incision or vagina; Accompanied by fever, peritonitis and other systemic symptoms; And AL confirmed by digestive tract radiography, CT scan or enteroscopy. | within 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| the change of surgical precedure | the change of intraoperative decision, including: (1) The change of the position of intestinal dissection; (2) Anastomotic stoma was removed and rebuilt or re-performed hartmann operation; (3) The performance of unplanned, preventive orifice, etc. due to ICG test results. | within the operation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongtao Zhang, Professor | Contact | 13801060364 | zhangzht@medmail.com.cn | |
| Hongwei Yao, Professor | Contact | 13611015609 | yaohongwei@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongtao Zhang, Professor | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38724058 | Derived | 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. |
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| 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 |
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| Non-application of near infrared-indocyanine green imaging system | Procedure | Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience |
|
| Beijing Friendship Hospital, Capital medical University | Recruiting | Beijing | Xicheng Dis | 100050 | China |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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