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NCT04518449 Clinical Trial

Medial Border of Laparoscopic D3 Lymphadenectomy for Right Colon Cancer

Colon Cancer Clinical Trial

Official title:
the Medial Border Along the Left Side of SMA Versus the Left Side of SMV in Laparoscopic D3 Lymphadenectomy for Right Colon Cancer, a Prospective Cohort Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04518449
Other study ID # MISC- Medial border of D3
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date October 31, 2025

Study information
Verified date February 2024
Source Shanghai Minimally Invasive Surgery Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigats the gastrointestinal functional outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery (SMA) versus the left side of superior mesenteric vein (SMV). This is a single center, prospective cohort study with a sample size of 264 patients. The primary endpoint is the incidence of diarrhea (evaluated using the Diarrhea Assessment Scale) one month after surgery.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 31, 2025
Est. primary completion date October 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age between 18 and 75 years - American Society of Anesthesiologists (ASA) score I to III - A biopsy proven histological diagnosis of colorectal carcinoma - tumor located at right half of colon - Undergoing laparoscopic right hemi-colectomy - preoperative staging cT2-4aN0M0 or cTanyN+M0 - willing to participate and informed consent signed Exclusion Criteria: - Pregnant or lactating women - Synchronous colorectal carcinoma - History of colorectal cancer or other malignant tumors - Clinical evidence of metastasis - Preoperative staging cT1N0 or cT4bNany - Emergency procedure

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• medial border along the left side of SMA
to place the medial border along the left side of SMA in laparoscopic D3 lymphadenectomy for right colon cancer
• medial border along the left side of SMV
to place the medial border along the left side of SMV in laparoscopic D3 lymphadenectomy for right colon cancer

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of diarrhea Diarrhea Assessment Scale: stool score = 5 one month after surgery
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