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Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection

Primary Purpose

Rectal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Transanal tube placement

Left colic artery preservation

Anastomotic reinforcing sutures

Robotic surgery

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Clinical diagnosis of low rectal cancer; 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)
Primary tumor has undergone histologically comfirmed rectal adenocarcinoma
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 2016 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

Jianmin XuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PSTLAR

NORLAR

Arm Description

Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer

Traditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement

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

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

NCT03609710

First Posted

July 23, 2018

Last Updated

August 2, 2018

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03609710

Brief Title

Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection

Official Title

The Effect of Combined Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube Placement in Robotic Low Anterior Resection for Rectal Cancer to Prevent Anastomic Leak：A Prospective, Single-center, Randomized Control Trial Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

February 28, 2019 (Anticipated)

Study Completion Date

May 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer.

Detailed Description

Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic 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

Low rectal cancer, Robotic surgery, Anastomotic leak

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PSTLAR

Arm Type

Experimental

Arm Description

Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer

Arm Title

NORLAR

Arm Type

Active Comparator

Arm Description

Traditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement

Intervention Type

Device

Intervention Name(s)

Transanal tube placement

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Left colic artery preservation

Intervention Description

Left colic artery preservation during operation for lower rectal cancer

Intervention Type

Procedure

Intervention Name(s)

Anastomotic reinforcing sutures

Intervention Description

Anastomotic reinforcing sutures during operation for lower rectal cancer

Intervention Type

Device

Intervention Name(s)

Robotic surgery

Intervention Description

Robotic 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

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: Clinical diagnosis of low rectal cancer; 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) Primary tumor has undergone histologically comfirmed rectal adenocarcinoma 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 2016 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

Facility Information:

Facility Name

Jianmin Xu

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianmin Xu, MD

Phone

+8613501984869

xujmin@aliyun.com

First Name & Middle Initial & Last Name & Degree

Wenju Chang, MD

Phone

+8613764476150

chang_erich@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection

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