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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Laparoscopic right hemicolectomy plus ERAS
* Procedure: Open right hemicolectomy plus ERAS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LRH plus ERAS<br>patients undergo Laparoscopic right hemicolectomy plus ERAS | Procedure: Laparoscopic right hemicolectomy plus ERAS<br>* patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs<br>* Other names: LRH ERAS;|
| Active Comparator: ORH plus ERAS<br>patients undergo open right hemicolectomy plus ERAS | Procedure: Open right hemicolectomy plus ERAS<br>* patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery after surgery, right hemicolectomy