Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

Study Overview
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Brief Summary
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The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.

Detailed Description
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The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery. Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse. The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.

Official Title
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Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.

Conditions
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Colonic Cancer

Intervention / Treatment
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* Procedure: laparoscopic right hemicolectomy with CME and central v
* Procedure: Open right hemicolectomy with CME and central v


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with right colonic cancer Exclusion Criteria: Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)
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
Interventional Model Description: Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic right hemicolectomy with CME and central v<br>laparoscopic right hemicolectomy with CME and central v | Procedure: laparoscopic right hemicolectomy with CME and central v<br>* laparoscopic right hemicolectomy with CME and central v<br>* Other names: LHC with CME;|
| Active Comparator: open right hemicolectomy with CME and central v<br>open right hemicolectomy with CME and central v | Procedure: Open right hemicolectomy with CME and central v<br>* Open right hemicolectomy with CME and central v<br>* Other names: ORH with CME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of lymph nodes (LNs) harvested among both groups | the number of lymph nodes (LNs) harvested among both groups | 30 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | operative time | INTRAOPERATIVE | 
| blood loss, | blood loss, | intraoperative | 
| post-operative complications | post-operative complications | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic Cancer, laparoscopic right hemicolectomy, complete mesocolic excision