Medial Border of Laparoscopic D3 Lymphadenectomy for Right Colon Cancer

February 22, 2024 updated by: Cai Zhenghao, Shanghai Minimally Invasive Surgery Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

conlon cancer located at right hemi-colon

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SMA group
the medial border along the left side of superior mesenteric artery (SMA)
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
SMV group
the medial border along the left side of superior mesenteric vein (SMV)
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of diarrhea
Time Frame: one month after surgery
Diarrhea Assessment Scale: stool score ≥ 5
one month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2022

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

August 16, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISC- Medial border of D3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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