NCT02944188

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
602

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

July 20, 2015

Last Update Submit

March 7, 2022

Conditions

Colon Cancer

Keywords

enhanced recovery after surgeryright hemicolectomy

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative complications

    The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification

    30 days from surgery

Secondary Outcomes (3)

  • overall survival

    3 years

  • disease-free survival

    3 years

  • operative mortality

    30 days post operatively

Other Outcomes (4)

  • operative time

    Day 1

  • estimated blood loss

    Day 1

  • number of retrieved lymph nodes

    1 week post operatively

  • +1 more other outcomes

Study Arms (2)

LRH plus ERAS

EXPERIMENTAL

patients undergo Laparoscopic right hemicolectomy plus ERAS

Procedure: Laparoscopic right hemicolectomy plus ERAS

ORH plus ERAS

ACTIVE COMPARATOR

patients undergo open right hemicolectomy plus ERAS

Procedure: Open right hemicolectomy plus ERAS

Interventions

Laparoscopic right hemicolectomy plus ERASPROCEDURE

patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

Also known as: LRH ERAS
LRH plus ERAS
Open right hemicolectomy plus ERASPROCEDURE

patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

ORH plus ERAS

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 and ≤ 75 years;
  • Primary tumor has undergone histologically confirmed right-sided colon adenocarcinoma;
  • 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)
  • Performance status (ECOG) 0\~1
  • Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; 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 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:

  • 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
  • Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  • Known drug abuse/ alcohol abuse
  • Legal incapacity or limited legal capacity
  • Pre-existing peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Hong Jiang, MD

    Fudan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy director of the colorectal cancer center

Study Record Dates

First Submitted

July 20, 2015

First Posted

October 25, 2016

Study Start

December 1, 2014

Primary Completion

December 30, 2017

Study Completion

December 30, 2020

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

CN(1)