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

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

transanual tube placement

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Anastomotic leak, Low rectal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Department of General Surgery, Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TTPLAR

NORLAR

Arm Description

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

Tranditional low anterior resection without transanual tube placement or ileostomy.

Outcomes

Primary Outcome Measures

anastomotic leak rate

Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02905968

First Posted

September 8, 2016

Last Updated

September 14, 2016

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02905968

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

Anastomotic leak, Low rectal cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TTPLAR

Arm Type

Experimental

Arm Description

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

Arm Title

NORLAR

Arm Type

No Intervention

Arm Description

Tranditional low anterior resection without transanual tube placement or ileostomy.

Intervention Type

Device

Intervention Name(s)

transanual tube placement

Intervention Description

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

Primary Outcome Measure Information:

Title

anastomotic leak rate

Description

Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.

Time Frame

30 days post operatively

Secondary Outcome Measure Information:

Title

Time Frame: Reoperation rate after anastomotic leak

Description

Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to excrement peritonitis, and re-operation as colostomy

Time Frame

30 days post operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jianmin Xu, MD

Phone

008613501984869

xujmin@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tuo Yi, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of General Surgery, Zhongshan Hospital, Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jianmin xu, MD

Phone

008613501984869

xujmin@aliyun.com

12. IPD Sharing Statement

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

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