Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt
NCT ID: NCT05421702
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-07-01
2023-04-30
Brief Summary
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Detailed Description
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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?
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A Operable colon cancer cases
All patients with operable colon cancer who will undergo laparoscopic conventional colectomy
laparoscopic conventional colectomy
Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.
Group B Operable colon cancer cases
All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision
laparoscopic complete mesocolic excision
Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.
Interventions
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laparoscopic conventional colectomy
Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.
laparoscopic complete mesocolic excision
Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age: all adult patients.
3. All diagnosed patients with operable cancer colon.
4. Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.
5. Fit patients.
Exclusion Criteria
2. Inoperable colon cancer.
3. Rectal cancer.
4. Unfit patients.
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Mostafa Farrag Mohammed
assistant lecturer of general surgery
Principal Investigators
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Ahmed E Ahmed, Professor
Role: STUDY_CHAIR
Sohag University
Mena Z Helmy, Ass prof.
Role: STUDY_DIRECTOR
Sohag University
Mostafa F Mohammed, Ass lecturer
Role: PRINCIPAL_INVESTIGATOR
Sohag University
Locations
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Sohag faculty of medicine
Sohag, , Egypt
Countries
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Other Identifiers
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Soh-Med-22-06-17
Identifier Type: -
Identifier Source: org_study_id