Sohag faculty of medicine
Sohag, 82524, Egypt
NCT Number: NCT05421702
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
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Interventional
Not applicable
Sohag, 82524, Egypt
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?
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.
Other names: D2 colectomy
Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.
Time frame: 2 weeks postoperative
Histopathological examination of the resected colon with lymph node status and number
Time frame: 2 weeks postoperative
Type of the colon cancer
Time frame: within 4 weeks postoperative
Yes/No
Time frame: within 4 weeks postoperative
Amount in cubic cm and nature of it with its management
Time frame: Intraoperative reporting
Yes/No and its type
Time frame: Intraoperative reporting
How managed
Time frame: 4 weeks postoperative
Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
Time frame: Reporting immediately postoperative (at end of operation)
Reporting operative time with measurements in minutes
Time frame: Intraoperative
Yes/No with measurement in Cubic Cm and how managed
Time frame: Intraoperative
Yes/No with measurement in Cubic Cm
Time frame: 2 weeks postoperative
Free or invaded
Time frame: 4 weeks postoperative
Cause and how to manage?
Time frame: 2 weeks Preoperative
According to primary tumor, regional nodes, metastasis (TNM) staging system
Time frame: 12 weeks postoperative
Reporting Yes/No with amount in cm3 and management
Time frame: 2 weeks postoperative
In cm
Time frame: Intraoperative and 4 weeks postoperative
Type and management
Time frame: 2 weeks preoperative
Carcinoembryonic antigen (CEA) level by ng/mL
Time frame: Intraoperative
Type of anastomosis (intra- or extracorporeal)
Time frame: preoperative
In years
Time frame: preoperative
measured by g/dl
Time frame: Intraoperative
Stapler or hand sewing
Time frame: 2 weeks preoperative
Histopathological examination
Time frame: 2 weeks Preoperative
Type of the neoadjuvant and duration
Time frame: 2 weeks preoperative
cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon
Time frame: 4 weeks postoperative
Type and management
Time frame: 3 days Preoperative
Mechanical and/or chemical
Time frame: 4 weeks postoperative
Yes/No Cardiopulmonary complications type and how managed
Time frame: intraoperative
Yes/No with the cause
Time frame: 1 week Postoperative
Yes/No
Time frame: 2 weeks Postoperative
in Milliliters
Time frame: 2 weeks Postoperative
in Milliliters
Time frame: 2 weeks postoperative
Yes/No and how managed
Time frame: 2 weeks postoperative
Postoperative ileus Yes/No
Time frame: 4 weeks postoperative
In days
Time frame: 4 weeks postoperative
Yes/No
Time frame: 2 weeks preoperative
mass/ulcer
Sohag University
Other
Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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