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

NCT ID: NCT02905968

Last Updated: 2016-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TTPLAR

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

Group Type: EXPERIMENTAL

transanual tube placement

Intervention Type: DEVICE

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

NORLAR

Tranditional low anterior resection without transanual tube placement or ileostomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transanual tube placement

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuo Yi, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

jianmin Xu, MD

Role: CONTACT

xujmin@aliyun.com

008613501984869

Facility Contacts

jianmin xu, MD

Role: primary

xujmin@aliyun.com

008613501984869

Other Identifiers

TTPLAR

Identifier Type: -

Identifier Source: org_study_id