Laparoscopic Versus Open Right Hemicolectomy Within ERAS in Right-sided Colon Cancer
Laparoscopic Versus Open Right Hemicolectomy in Treatment of Right-sided Colon Cancer Within an Enhanced Recovery After Surgery (ERAS) Protocol
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Shanghai, China, 200032
- Zhongshan hospital, Fudan University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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 |
|---|---|
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Experimental: LRH plus ERAS
patients undergo Laparoscopic right hemicolectomy plus ERAS
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patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
Other Names:
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Active Comparator: ORH plus ERAS
patients undergo open right hemicolectomy plus ERAS
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patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of postoperative complications
Time Frame: 30 days from surgery
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The incidence of postoperative complications within 30 days according to the Clavien-Dindo classification
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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
|
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operative mortality
Time Frame: 30 days post operatively
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Deaths related to surgery within 30 days from surgery
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30 days post operatively
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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
|
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estimated blood loss
Time Frame: Day 1
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Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.
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Day 1
|
|
number of retrieved lymph nodes
Time Frame: 1 week post operatively
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Numbers according to the pathological report
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1 week post operatively
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postoperative hospital stay
Time Frame: 30 days post operatively
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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
Sponsor
Investigators
- Study Director: Hong Jiang, MD, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERAS-02
- 82345432 (Other Grant/Funding Number: Shanghai key research projects)
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