NCT03609710

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

August 3, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

July 23, 2018

Last Update Submit

August 2, 2018

Conditions

Rectal Cancer

Keywords

Low rectal cancerRobotic surgeryAnastomotic leak

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Reoperation rate after anastomotic leak

    30 days post operatively

Study Arms (2)

PSTLAR

EXPERIMENTAL

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

Device: Transanal tube placementProcedure: Left colic artery preservationProcedure: Anastomotic reinforcing suturesDevice: Robotic surgery

NORLAR

ACTIVE COMPARATOR

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

Device: Robotic surgery

Interventions

Transanal tube placementDEVICE

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

PSTLAR
Left colic artery preservationPROCEDURE

Left colic artery preservation during operation for lower rectal cancer

PSTLAR
Anastomotic reinforcing suturesPROCEDURE

Anastomotic reinforcing sutures during operation for lower rectal cancer

PSTLAR
Robotic surgeryDEVICE

Robotic low anterior resection for rectal cancer

NORLARPSTLAR

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianmin Xu

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 1, 2018

Study Start

January 1, 2018

Primary Completion

February 28, 2019

Study Completion

May 30, 2019

Last Updated

August 3, 2018

Record last verified: 2018-01

Locations

CN(1)