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Trial record 2 of 244 for:    rectal cancer | Recruiting, Not yet recruiting, Available Studies | Interventional Studies | Other

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

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ClinicalTrials.gov Identifier: NCT02905968
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Device: transanual tube placement Phase 2 Phase 3

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

Study Type : Interventional
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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



Primary Outcome Measures :
  1. anastomotic leak rate [ Time Frame: 30 days post operatively ]
    Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.


Secondary Outcome Measures :
  1. Time Frame: Reoperation rate after anastomotic leak [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905968


Contacts
Contact: jianmin Xu, MD 008613501984869 xujmin@aliyun.com

Locations
China
Department of General Surgery, Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: jianmin xu, MD    008613501984869    xujmin@aliyun.com   
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Tuo Yi, MD Fudan University

Responsible Party: Xu jianmin, Prof., Fudan University
ClinicalTrials.gov Identifier: NCT02905968     History of Changes
Other Study ID Numbers: TTPLAR
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016

Keywords provided by Xu jianmin, Fudan University:
Anastomotic leak
Low rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Anastomotic Leak
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Postoperative Complications
Pathologic Processes