Enterotomy Closure and Minimally Invasive Gastrectomy | NCT04901585

Studies
Enterotomy Closure and Minimally Invasive Gastrectomy

NCT04901585

Sponsor

Federico II University

Status

Completed

Last Update Posted

May 25, 2021Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Gastric Cancer

Interventions

Totally intracorporeal distal gastrectomy

Countries

Italy

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

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

May 20, 2021

First Submission Date that Met QC Criteria

May 20, 2021

First Posted Date

May 25, 2021Actual

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

May 20, 2021

Last Update Posted Date

May 25, 2021Actual

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

All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.

Detailed Description

Different ways to fashion intracorporeal anstomoses will be investigated: robotic vs laparoscopic approach; laparoscopic HD vs 3D vs 4K technologies; single layer vs double layer enterotomy closure. Additionally double layer enterotomies will be analysed layer by layer, comparing running vs interrupted suture, presence vs absence of deep corner suture and type of suture thread (barbed, braided, non braided suture)

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

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Totally intracorporeal distal gastrectomy		All patients who underwent minimally invasive distal gastrectomy with intracorporeal anastomosis for gastric cancer	Procedure: Totally intracorporeal distal gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Totally intracorporeal distal gastrectomy	Procedure	Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure	Totally intracorporeal distal gastrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative complications	The better way to fashion enterotomy closure	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
laparoscopic or robotic partial gastrectomy for gastric cancer
Roux en Y or Billroth II reconstruction

Exclusion Criteria:

Age < 18 years
open gastrectomy
total gastrectomy
Billroth I reconstruction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who underwent laparoscopic or robotic partial gastrectomy for gastric cancer with Roux en Y or Billroth II reconstruction

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Naples Federico II		Naples		80131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided