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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905968
• Other study ID #: TTPLAR
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 8, 2016
• Last updated: September 14, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: Fudan University
• Contact: jianmin Xu, MD
• Phone: 008613501984869
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Fudan university
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• transanual tube placement
Transanual tube placement after anastomosis in low anterior resection for rectal cancer.

Locations

Country	Name	City	State
China	Department of General Surgery, Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic leak rate	Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.	30 days post operatively	Yes
Secondary	Time Frame: Reoperation rate after anastomotic leak	Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to excrement peritonitis, and re-operation as colostomy	30 days post operatively	Yes