Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer

The Safety and Effect of Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer to Prevent Anastomotic Leak: Randomized Control Trial Study

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02905968

Enrollment

520

Registered

2016-09-19

Start date

2016-01-31

Completion date

2018-12-31

Last updated

2016-09-19

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

Conditions

Rectal Cancer

Keywords

Anastomotic leak, Low rectal cancer

Brief summary

The purpose of this study is to evaluate the effectiveness of transanual tube placement in low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.

Detailed description

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

Interventions

DEVICEtransanual tube placement

Transanual tube placement after anastomosis in 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

1. Age ≥ 18 and ≤ 75 years; 2. Primary tumor has undergone histologically confirmed rectal adenocarcinoma; 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). 3. 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 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system). 4. Performance status (ECOG) 0\ 1 5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization) 6. 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); 7. Written informed consent for participation in the trial.

Exclusion criteria

1. Body mass index (BMI) more than 30 kg/m2. 2. 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. 3. 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
Time Frame: 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

Contacts

Primary Contactjianmin Xu, MD

xujmin@aliyun.com008613501984869

Outcome results

None listed

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