Medial Border of Laparoscopic D3 Lymphadenectomy for Righ... | NCT04518449

Studies
Medial Border of Laparoscopic D3 Lymphadenectomy for Right Colon Cancer

NCT04518449

Sponsor

Shanghai Minimally Invasive Surgery Center

Status

Withdrawn

Last Update Posted

Feb 26, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Colon Cancer

Interventions

medial border along the left side of SMA
medial border along the left side of SMV

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no funds

Expanded Access Info

Start Date

Dec 1, 2022Estimated

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Oct 31, 2025Estimated

First Submitted Date

Aug 16, 2020

First Submission Date that Met QC Criteria

Aug 16, 2020

First Posted Date

Aug 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2024

Last Update Posted Date

Feb 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cai Zhenghao, Attending surgeon of gastrointestinal surgery，Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai Minimally Invasive Surgery CenterPrincipal Investigator

Lead Sponsor

Shanghai Minimally Invasive Surgery CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
medial border along the left side of SMA	Procedure	to place the medial border along the left side of SMA in laparoscopic D3 lymphadenectomy for right colon cancer	SMA group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

conlon cancer located at right hemi-colon

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided