Enterotomy Closure and Minimally Invasive Gastrectomy

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Totally intracorporeal distal gastrectomy

Procedure

Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure

Primary outcomes

Postoperative complications

Time frame: 1 month

The better way to fashion enterotomy closure

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Enterotomy Closure After Minimally Invasive Distal Gastrectomy With Intracorporeal Anastomosis.

Important dates

Study start: 2009
Primary completion: 2019
Study completion: 2021
First posted: May 25, 2021
Registry last updated: May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed