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

Primary Purpose

Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Laparoscopic right hemicolectomy plus ERAS

Open right hemicolectomy plus ERAS

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring enhanced recovery after surgery, right hemicolectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LRH plus ERAS

ORH plus ERAS

Arm Description

patients undergo Laparoscopic right hemicolectomy plus ERAS

patients undergo open right hemicolectomy plus ERAS

Outcomes

Primary Outcome Measures

incidence of postoperative complications

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

Secondary Outcome Measures

overall survival

Time from randomization to deaths resulting from any reason

disease-free survival

Time from randomization to recurrence at any site or deaths resulting from any reason

operative mortality

Deaths related to surgery within 30 days from surgery

Full Information

NCT ID

NCT02944188

First Posted

July 20, 2015

Last Updated

March 7, 2022

Sponsor

Xu jianmin

1. Study Identification

Unique Protocol Identification Number

NCT02944188

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

December 1, 2014 (Actual)

Primary Completion Date

December 30, 2017 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xu jianmin

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

enhanced recovery after surgery, right hemicolectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

602 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LRH plus ERAS

Arm Type

Experimental

Arm Description

patients undergo Laparoscopic right hemicolectomy plus ERAS

Arm Title

ORH plus ERAS

Arm Type

Active Comparator

Arm Description

patients undergo open right hemicolectomy plus ERAS

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic right hemicolectomy plus ERAS

Other Intervention Name(s)

LRH ERAS

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Open right hemicolectomy plus ERAS

Intervention Description

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

Primary Outcome Measure Information:

Title

incidence of postoperative complications

Description

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

Time Frame

30 days from surgery

Secondary Outcome Measure Information:

Title

overall survival

Description

Time from randomization to deaths resulting from any reason

Time Frame

3 years

Title

disease-free survival

Description

Time from randomization to recurrence at any site or deaths resulting from any reason

Time Frame

3 years

Title

operative mortality

Description

Deaths related to surgery within 30 days from surgery

Time Frame

30 days post operatively

Other Pre-specified Outcome Measures:

Title

operative time

Description

Time from start of incision to finish of abdomial closure

Time Frame

Day 1

Title

estimated blood loss

Description

Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.

Time Frame

Day 1

Title

number of retrieved lymph nodes

Description

Numbers according to the pathological report

Time Frame

1 week post operatively

Title

postoperative hospital stay

Description

The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.

Time Frame

30 days post operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hong Jiang, MD

Organizational Affiliation

Fudan University

Official's Role

Study Director

Facility Information:

Facility Name

Zhongshan Hospital, Fudan University

City

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

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

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