NCT04901585

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

11 years

First QC Date

May 20, 2021

Last Update Submit

May 20, 2021

Conditions

Gastric Cancer

Keywords

intracorporeal gastrectomyenterotomy closure

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    The better way to fashion enterotomy closure

    1 month

Study Arms (1)

Totally intracorporeal distal gastrectomy

All patients who underwent minimally invasive distal gastrectomy with intracorporeal anastomosis for gastric cancer

Procedure: Totally intracorporeal distal gastrectomy

Interventions

Totally intracorporeal distal gastrectomyPROCEDURE

Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure

Totally intracorporeal distal gastrectomy

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years
  • open gastrectomy
  • total gastrectomy
  • Billroth I reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

January 1, 2009

Primary Completion

December 31, 2019

Study Completion

April 1, 2021

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

IT(1)