Enterotomy Closure and Minimally Invasive Gastrectomy

NCT ID: NCT04901585

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2021-04-01

Brief Summary

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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

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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)

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Totally intracorporeal distal gastrectomy

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

Totally intracorporeal distal gastrectomy

Intervention Type PROCEDURE

Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure

Interventions

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Totally intracorporeal distal gastrectomy

Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Marco Milone

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Naples Federico II

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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intragastrectomy

Identifier Type: -

Identifier Source: org_study_id

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