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

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Fudan University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Rectal Cancer

Treatments

Device: transanual tube placement

Study type

Interventional

Funder types

Other

Identifiers

NCT02905968
TTPLAR

Details and patient eligibility

About

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.

Full description

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

Enrollment

520 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 and ≤ 75 years;
  • 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).
  • 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).
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

520 participants in 2 patient groups

TTPLAR
Experimental group
Description:
Transanual tube placement after anastomosis in low anterior resection for rectal cancer.
Treatment:
Device: transanual tube placement
NORLAR
No Intervention group
Description:
Tranditional low anterior resection without transanual tube placement or ileostomy.

Trial contacts and locations

0

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Central trial contact

jianmin Xu, MD

Data sourced from clinicaltrials.gov

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