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A randomized controlled trial of risk assessment score combined with fluorescence angiography of anastomosis in predicting anastomotic leakage after laparoscopic assisted anterior resection of lower rectal cancer

A randomized controlled trial of risk assessment score combined with fluorescence angiography of anastomosis in predicting anastomotic leakage after laparoscopic assisted anterior resection of lower rectal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029540
Enrollment
Unknown
Registered
2020-02-03
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anastomotic leakage of rectal cancer

Interventions

experimental group:according to risk assessment of anastomotic leakage to perform preventive stoma
control group:according to the wishes of the surgeon to perform preventive stoma

Sponsors

Renji Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-75 years; 2) The rectal adenocarcinoma was confirmed by pathology ; 3) The patients whose lower margin of cancer was less than 7 cm from the anal margin; 4) No other multiple primary cancer was found; 5) Having sufficient organ function; 6) Patients or family members, who can understand the study plan and are willing to participate in the study, provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with severe intestinal obstruction or intestinal perforation who need emergency surgical resection; 2) Previous colorectal surgery may affect the reconstruction of digestive tract; 3) Combined organ resection is needed; 4) Pregnant or lactating women; 5) Serious mental illness; 6) Severe emphysema, interstitial pneumonia and other intolerable patients; 7) Patients or family members could not understand the conditions and objectives of this study; 8) Patients with a history of adverse reactions or allergies to ICG, iodine, or iodine dyes are not eligible.

Design outcomes

Primary

MeasureTime frame
Postoperative anastomotic leakage rate;Preventive stoma rate;

Countries

China

Contacts

Public ContactMing Zhong

Renji Hospital, School of Medicine, Shanghai Jiaotong University

drzhongming1966@163.com+86 13003152950

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026