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

NCT ID: NCT03609710

Last Updated: 2018-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-05-30

Brief Summary

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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

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

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PSTLAR

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

Group Type EXPERIMENTAL

Transanal tube placement

Intervention Type DEVICE

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

Left colic artery preservation

Intervention Type PROCEDURE

Left colic artery preservation during operation for lower rectal cancer

Anastomotic reinforcing sutures

Intervention Type PROCEDURE

Anastomotic reinforcing sutures during operation for lower rectal cancer

Robotic surgery

Intervention Type DEVICE

Robotic low anterior resection for rectal cancer

NORLAR

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

Group Type ACTIVE_COMPARATOR

Robotic surgery

Intervention Type DEVICE

Robotic low anterior resection for rectal cancer

Interventions

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Transanal tube placement

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

Intervention Type DEVICE

Left colic artery preservation

Left colic artery preservation during operation for lower rectal cancer

Intervention Type PROCEDURE

Anastomotic reinforcing sutures

Anastomotic reinforcing sutures during operation for lower rectal cancer

Intervention Type PROCEDURE

Robotic surgery

Robotic low anterior resection for rectal cancer

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xu jianmin

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jianmin Xu

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Jianmin Xu, MD

Role: primary

+8613501984869

Wenju Chang, MD

Role: backup

+8613764476150

Other Identifiers

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PSTLAR

Identifier Type: -

Identifier Source: org_study_id

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