An Analysis of Clinical Efficacy Based on the Robotic, Laparoscopic, and Open Approach in Radical Resection of Rectal Cancer

April 8, 2019 updated by: First Affiliated Hospital Xi'an Jiaotong University
A retrospective study was done on the medical records for 24 rectal cancer patients underwent robotic proctectomy from September 2017 to July 2018 at the First Affiliated Hospital of Xi'an Jiaotong University.In the same department,a total of 25 patients who treated with laparoscopic proctectomy and 24 patients underwent open proctectomy were were selected as controls in a 1:1:1 ratio. Comparing the perioperative conditions and hospitalization related costs of the three groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of rectal cancer

Description

Inclusion Criteria:

  • endoscopic biopsy pathological diagnosis of rectal cancer is clear, preoperative CT, MRI examination did not see the tumor directly invaded the surrounding organs;
  • blood test, cardiac ultrasound, lung ventilation function and other preoperative examination without absolute surgical contraindications;
  • without distant metastasis such as liver, lung, bone, and abdominal cavity.

Exclusion Criteria:

  • there is distant organ transfer or extensive abdominal metastasis;
  • emergency surgery for acute intestinal obstruction, hemorrhage, perforation, intestinal rupture, etc.;
  • combined with other primary malignant tumors;
  • other colonectomy and combined with other organ resection;
  • patients with severe basic diseases unable to tolerate surgery;
  • pregnant and lactating women;
  • patients who underwent neoadjuvant radiotherapy and chemotherapy before surgery;
  • those who underwent palliative surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RG
RG: robotic group
Procedure: open, laparoscopic, and robotic
Radical resection of rectal cancer in robotic, laparoscopic, and open approach
LG
LG:laparoscopic group,
Procedure: open, laparoscopic, and robotic
Radical resection of rectal cancer in robotic, laparoscopic, and open approach
OG
OG：open group
Procedure: open, laparoscopic, and robotic
Radical resection of rectal cancer in robotic, laparoscopic, and open approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative complication rate，%
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Urine tube time,days;
Time Frame: 2 weeks
2 weeks
operation time,minutes;
Time Frame: 2 weeks
2 weeks
intraoperative bleeding,ml;
Time Frame: 2 weeks
2 weeks
number of lymph node detection,
Time Frame: 2 weeks
2 weeks
exhaust time,days;
Time Frame: 2 weeks
2 weeks
intake time, days;
Time Frame: 2 weeks
2 weeks
postoperative hospital stay,days;
Time Frame: 2 weeks
2 weeks
hospitalization expenses,yuan
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2019LSK-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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