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NCT04901585 Clinical Trial

Enterotomy Closure and Minimally Invasive Gastrectomy

Gastric Cancer Clinical Trial

Official title:
Enterotomy Closure After Minimally Invasive Distal Gastrectomy With Intracorporeal Anastomosis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04901585
Other study ID # intragastrectomy
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date April 1, 2021

Study information
Verified date May 2021
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date April 1, 2021
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Totally intracorporeal distal gastrectomy
Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure

Locations
Country Name City State
Italy University of Naples Federico II Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative complications The better way to fashion enterotomy closure 1 month
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