NCT04518449

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

August 16, 2020

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of diarrhea

    Diarrhea Assessment Scale: stool score ≥ 5

    one month after surgery

Study Arms (2)

SMA group

the medial border along the left side of superior mesenteric artery (SMA)

Procedure: medial border along the left side of SMA

SMV group

the medial border along the left side of superior mesenteric vein (SMV)

Procedure: medial border along the left side of SMV

Interventions

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

SMA group

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

SMV group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

conlon cancer located at right hemi-colon

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending surgeon of gastrointestinal surgery,Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 19, 2020

Study Start

December 1, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2025

Last Updated

February 26, 2024

Record last verified: 2024-02