Enterotomy Closure and Minimally Invasive Gastrectomy

May 20, 2021 updated by: Marco Milone, Federico II University

Enterotomy Closure After Minimally Invasive Distal Gastrectomy With Intracorporeal Anastomosis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • University of Naples Federico II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Totally intracorporeal distal gastrectomy
All patients who underwent minimally invasive distal gastrectomy with intracorporeal anastomosis for gastric cancer
Procedure: Totally intracorporeal distal gastrectomy
Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intragastrectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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