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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944188
• Other study ID #: ERAS-02
• Secondary ID: 82345432
• Status: Completed
• Phase: N/A
• Start date: December 1, 2014
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-HCG) or breast-feeding

3. Known drug abuse/ alcohol abuse

4. Legal incapacity or limited legal capacity

5. Pre-existing peripheral neuropathy.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• Laparoscopic right hemicolectomy plus ERAS
patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
• Open right hemicolectomy plus ERAS
patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xu jianmin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	operative time	Time from start of incision to finish of abdomial closure	Day 1
Other	estimated blood loss	Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.	Day 1
Other	number of retrieved lymph nodes	Numbers according to the pathological report	1 week post operatively
Other	postoperative hospital stay	The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.	30 days post operatively
Primary	incidence of postoperative complications	The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification	30 days from surgery
Secondary	overall survival	Time from randomization to deaths resulting from any reason	3 years
Secondary	disease-free survival	Time from randomization to recurrence at any site or deaths resulting from any reason	3 years
Secondary	operative mortality	Deaths related to surgery within 30 days from surgery	30 days post operatively