The China Laparoscopic Right Hemicolectomy SNAPSHOT | NCT04628182

Studies
The China Laparoscopic Right Hemicolectomy SNAPSHOT

NCT04628182

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Jun 30, 2022Actual

Enrollment

1,579Estimated

Phase

Not provided

Conditions

Right Hemicolectomy
Colon Cancer

Interventions

Not provided

Countries

China

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Jun 28, 2022Actual

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Nov 9, 2020

First Submission Date that Met QC Criteria

Nov 9, 2020

First Posted Date

Nov 13, 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

Jun 28, 2022

Last Update Posted Date

Jun 30, 2022Actual

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

The main objective is to explore the current practice of right hemicolectomy for colon cancer located in the ascending colon and hepatic flexure in selected Chinese high quality and high volume centres. This study will identify a potential area to improve the level of standard care and serve as a reference cohort to which planned standardization and addition of innovative aspects can be compared to

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

1,579Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post-operative anastomotic leakages	Number of post-operative anastomotic leakages within 30 days.	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Segmental right sided hemicolectomy (including extended)
Cancer stage 1-3 (CT-staged)
No prior abdominal surgery

Exclusion Criteria:

Stage cT4b, perforated disease
Acute obstruction
Emergency surgery
Right hemicolectomy or ileocaecal resection as part of a large procedure such as subtotal colectomy or panproctocolectomy
Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants with non-metastasized right sided colon cancer without ingrowth into other organs suitable for elective radical resection of the ascending colon.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital	Recruiting	Beijing	Beijing Municipality	100050	China

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