Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection

The Effect of Combined Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube Placement in Robotic Low Anterior Resection for Rectal Cancer to Prevent Anastomic Leak：A Prospective, Single-center, Randomized Control Trial Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03609710

Enrollment

500

Registered

2018-08-01

Start date

2018-01-01

Completion date

2019-05-30

Last updated

2018-08-03

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

Conditions

Rectal Cancer

Keywords

Low rectal cancer, Robotic surgery, Anastomotic leak

Brief summary

The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer.

Detailed description

Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer

Interventions

DEVICETransanal tube placement

Transanual tube placement after anastomosis in low anterior resection for rectal cancer.

PROCEDURELeft colic artery preservation

Left colic artery preservation during operation for lower rectal cancer

PROCEDUREAnastomotic reinforcing sutures

Anastomotic reinforcing sutures during operation for lower rectal cancer

DEVICERobotic surgery

Robotic low anterior resection for rectal cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of low rectal cancer; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin) * Primary tumor has undergone histologically comfirmed rectal adenocarcinoma * Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2016 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system) * Performance status (ECOG) 0\ 1 * Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization) * Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization); * Written informed consent for participation in the trial.

Exclusion criteria

* Body mass index (BMI) more than 30 kg/m2 * Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history * History of accepting abdominal surgery

Design outcomes

Primary

Measure	Time frame	Description
Anastomotic leak rate	30 days post operatively	Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.

Secondary

Measure	Time frame	Description
Reoperation rate after anastomotic leak	30 days post operatively	Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to excrement peritonitis, and re-operation as colostomy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026