Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt

Study Overview
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Brief Summary
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The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt

Detailed Description
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Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment . When Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC). The principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes. CME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen. Some surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival. Although CME has a theoretical advantages and promising early results, it is not widely adopted as the standard in some areas. CME is technically more demanding than CC and suggested to be associated with more intraoperative visceral injuries and non-surgical complications and many doubts persist about safety and efficacy of the procedure. The questions of interest and research, should CME be regarded as the optimal procedure for colon cancer cases? And also another question; is conventional colectomy suboptimal?

Official Title
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Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt

Conditions
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Colon Cancer Stage I, Colon Cancer Stage II

Intervention / Treatment
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* Procedure: laparoscopic conventional colectomy
* Procedure: laparoscopic complete mesocolic excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sexes will be included. Age: all adult patients. All diagnosed patients with operable cancer colon. Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon. Fit patients. Exclusion Criteria: Irresectable colon cancer. Inoperable colon cancer. Rectal cancer. Unfit patients.
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: Operable colon cancer cases
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A Operable colon cancer cases<br>All patients with operable colon cancer who will undergo laparoscopic conventional colectomy | Procedure: laparoscopic conventional colectomy<br>* Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.<br>* Other names: D2 colectomy;|
| Active Comparator: Group B Operable colon cancer cases<br>All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision | Procedure: laparoscopic complete mesocolic excision<br>* Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative lymph node status | Histopathological examination of the resected colon with lymph node status and number | 2 weeks postoperative | 
| Postoperative histopathological result | Type of the colon cancer | 2 weeks postoperative | 
| Occurence of anastomotic leak | Yes/No | within 4 weeks postoperative | 
| Amount of anastomotic leak | Amount in cubic cm and nature of it with its management | within 4 weeks postoperative | 
| Intraoperative visceral injury type | Yes/No and its type | Intraoperative reporting | 
| Intraoperative visceral injury management | How managed | Intraoperative reporting | 
| Postoperative complications | Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System | 4 weeks postoperative | 
| Operative time | Reporting operative time with measurements in minutes | Reporting immediately postoperative (at end of operation) | 
| Intraoperative vascular injury | Yes/No with measurement in Cubic Cm and how managed | Intraoperative | 
| Intraoperative blood loss | Yes/No with measurement in Cubic Cm | Intraoperative | 
| Resection margins in postoperative histopathological status | Free or invaded | 2 weeks postoperative | 
| Postoperative peritonitis | Cause and how to manage? | 4 weeks postoperative | 
| Colon cancer stage | According to primary tumor, regional nodes, metastasis (TNM) staging system | 2 weeks Preoperative | 
| Postoperative faecal fistula | Reporting Yes/No with amount in cm3 and management | 12 weeks postoperative | 
| length of resected mesocolon | In cm | 2 weeks postoperative | 
| Urological complications | Type and management | Intraoperative and 4 weeks postoperative | 
| Carcinoembryonic antigen (CEA) level | Carcinoembryonic antigen (CEA) level by ng/mL | 2 weeks preoperative | 
| Type of anastomosis | Type of anastomosis (intra- or extracorporeal) | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | In years | preoperative | 
| Preoperative haemoglobin level | measured by g/dl | preoperative | 
| Type of colonic anastomosis | Stapler or hand sewing | Intraoperative | 
| Preoperative histopathological result | Histopathological examination | 2 weeks preoperative | 
| Neoadjuvant therapy | Type of the neoadjuvant and duration | 2 weeks Preoperative | 
| Site of cancer colon | cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon | 2 weeks preoperative | 
| Neurological complications | Type and management | 4 weeks postoperative | 
| Preoperative preparation | Mechanical and/or chemical | 3 days Preoperative | 
| Cardiopulmonary complications | Yes/No Cardiopulmonary complications type and how managed | 4 weeks postoperative | 
| Conversion to open surgery | Yes/No with the cause | intraoperative | 
| application of subcutaneous suction | Yes/No | 1 week Postoperative | 
| Average daily amount in subcutaneous suction | in Milliliters | 2 weeks Postoperative | 
| Average daily amount in intraperitoneal drain | in Milliliters | 2 weeks Postoperative | 
| Wound infection | Yes/No and how managed | 2 weeks postoperative | 
| Postoperative ileus | Postoperative ileus Yes/No | 2 weeks postoperative | 
| Hospital stay | In days | 4 weeks postoperative | 
| Wound dehiscence | Yes/No | 4 weeks postoperative | 
| Preoperative colonoscopic examination result | mass/ulcer | 2 weeks preoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colectomy, Colon cancer, Mesocolic, Conventional, Laparoscopic, Surgical, Pathological