Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer

March 7, 2022 updated by: Xu jianmin

Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol

In this study, the investigators have compared the clinical outcomes of the laparoscopic and open right hemicolectomy within enhanced recovery after surgery (ERAS) programs in the treatment of right-sided colon cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 75 years; (2) Histologically confirmed right-sided colon adenocarcinoma；(3) Clinical stage I-III; (4) Performance status (ECOG) 0-1; (5) Adequate hematological, hepatic and renal function. Patients operated on as an emergency, or with tumours in the transverse colon, or with other previous malignancy within 5 years were excluded.

All particapants were recruited and randomly assigned to receive laproscopic or open right hemicoloectomy. All patients were treated with an ERAS protocol. The primary end-point was the incidence of postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification. The secondary end-points were ERAS adherence, readmissions, reoperations, hospital length of stay, mortality, and survivals. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Study Type

Interventional

Enrollment (Actual)

602

Phase

  • Not Applicable

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
      • Shanghai, China, 200032
        • Zhongshan Hospital, Fudan 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years;
  2. Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;
  3. Together with clinical or radiological evidence of Stage(T1-2,N0, M0) Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)
  4. Performance status (ECOG) 0~1
  5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
  6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
  7. Written informed consent for participation in the trial.

Exclusion Criteria:

  1. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  2. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  3. Known drug abuse/ alcohol abuse
  4. Legal incapacity or limited legal capacity
  5. Pre-existing peripheral neuropathy.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LRH plus ERAS
patients undergo Laparoscopic right hemicolectomy plus ERAS
Procedure: Laparoscopic right hemicolectomy plus ERAS
patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
Other Names:
  • LRH ERAS
Active Comparator: ORH plus ERAS
patients undergo open right hemicolectomy plus ERAS
Procedure: Open right hemicolectomy plus ERAS
patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postoperative complications
Time Frame: 30 days from surgery
The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification
30 days from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 years
Time from randomization to deaths resulting from any reason
3 years
disease-free survival
Time Frame: 3 years
Time from randomization to recurrence at any site or deaths resulting from any reason
3 years
operative mortality
Time Frame: 30 days post operatively
Deaths related to surgery within 30 days from surgery
30 days post operatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: Day 1
Time from start of incision to finish of abdomial closure
Day 1
estimated blood loss
Time Frame: Day 1
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
Day 1
number of retrieved lymph nodes
Time Frame: 1 week post operatively
Numbers according to the pathological report
1 week post operatively
postoperative hospital stay
Time Frame: 30 days post operatively
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
30 days post operatively

Collaborators and Investigators

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

Sponsor

Xu jianmin

Investigators

  • Study Director: Hong Jiang, MD, Fudan 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)

December 1, 2014

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

October 23, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERAS-02
  • 82345432 (Other Grant/Funding Number: Shanghai key research projects)

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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