- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07655856
Inferior Mesenteric Artery First Combined With Complete Medial Approach for Laparoscopic Splenic Flexure Mobilization in Left Sided Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laparoscopic left-sided colon cancer radical resection is primarily employed for the treatment of tumors located in distal transverse colon , splenic flexure of colon, descending colon, and proximal segment of the sigmoid colon. Numerous factors impact the difficulty of surgery, with research suggesting that mobilization of the splenic flexure independently predicts longer operative times in laparoscopic left-sided colon cancer radical resection . Splenic flexure mobilization is independently associated with an increased risk of splenic injury, which contributes to elevated short-term and long-term mortality risks in patients. The crucial aspect of radical surgery is complete mesocolic excision (CME) with central vascular ligation and the Japanese D3 lymphadenectomy. For tumors located in descending colon and sigmoid-descending junction, the lymph node dissection range includes the central lymph node group (No.253) at the root of the inferior mesenteric artery (IMA) . In cases of cancer in the left half of the transverse colon or in the splenic flexure of colon, in addition to IMA root lymph node dissection, it is imperative to perform dissection of lymph nodes (No.223) at the root of the middle colic artery (MCA).Therefore, for laparoscopic left-sided colon cancer radical resection, ensuring the safety of splenic flexure mobilization and maintaining the quality of lymph nodes dissection are both crucial.
Currently, traditional surgical approaches for laparoscopic left-sided colon cancer radical resection include the medial approach, lateral approach, anterior approach, and various combinations of these methods. Due to variations in anatomical understanding, many teams propose the combined application of multiple approaches, each demonstrating a certain level of safety and feasibility.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: omar mohamed doctor, master
- Phone Number: +0201025104556
- Email: Omar_Mokbel@aun.edu.eg
Study Contact Backup
- Name: momen shalkamy abdelgwad, phd
- Phone Number: 01017520093
- Email: moamen.shalkamy@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients aged 18-70 years old with confirmed colorectal cancer diagnosis by histopathology with obligatory splenic flexure mobilization and had laparoscopic surgery with curative intent were included.
Exclusion Criteria:
- Those younger than 18 years or older than 70 years.
- Those undergoing non-cancer resections, or completion surgery or palliative procedures.
- Those with locally advanced ( extra colonic extension ) or metastatic tumors.
- Those with advanced comorbidities ( laparoscopy is contraindicated )
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 |
|---|---|
|
Active Comparator: inferior mesenteric artery first with complete medial approach
|
The patient was positioned in the modified lithotomy position with the main surgeon standing in between the abducted legs. The patient's head is lowered by 15° (Trendelenburg position), and table was 20° right-tilted. The position was adjusted at the time of splenic flexure mobilization to head elevation by 20° to let the small bowel go down toward the pelvis. Five ports were introduced [Figure 1]: a 10-mm port in the midline 4 cm above the umbilicus to increase the field of view, a second 5 mm port in the right midclavicular line just below the umbilicus, a third 10-12-mm port at the right midclavicular line in the right iliac fossa, a fourth 5-mm port in the left midclavicular line 2 cm above the level of the umbilicus, and a last 5-mm port in the midline 4 cm above the pubic bone. Port sites for laparoscopic left colectomy. The tumor was localized by either visual inspection or intraoperative colonoscopy. The summit of sigmoid colon was then pulled anteriorly with a grasper toward |
|
Active Comparator: lateral approach
|
The patient was positioned in the modified lithotomy position with the main surgeon standing in between the abducted legs. The patient's head is lowered by 15° (Trendelenburg position), and table was 20° right-tilted. The position was adjusted at the time of splenic flexure mobilization to head elevation by 20° to let the small bowel go down toward the pelvis. Five ports were introduced [Figure 1]: a 10-mm port in the midline 4 cm above the umbilicus to increase the field of view, a second 5 mm port in the right midclavicular line just below the umbilicus, a third 10-12-mm port at the right midclavicular line in the right iliac fossa, a fourth 5-mm port in the left midclavicular line 2 cm above the level of the umbilicus, and a last 5-mm port in the midline 4 cm above the pubic bone. Port sites for laparoscopic left colectomy. The tumor was localized by either visual inspection or intraoperative colonoscopy. The summit of sigmoid colon was then pulled anteriorly with a grasper toward |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of safety and effectiveness of inferior mesenteric artery first in combination with complete medial approach in splenic mobilization in left sided colorectal cancer .
Time Frame: 6 month
|
number of harvested lymph nodes
|
6 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- laparoscopic colorectal cancer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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