Enterotomy Closure and Minimally Invasive Gastrectomy

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Totally intracorporeal distal gastrectomy

• Registration Number: NCT04901585
• Lead Sponsor: Federico II University

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.

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 Timeline

• Study Start: 2009-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2021-04-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Study First Posted: 2021-05-25
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Totally intracorporeal distal gastrectomy	Totally intracorporeal distal gastrectomy	All patients who underwent minimally invasive distal gastrectomy with intracorporeal anastomosis for gastric cancer

Primary Outcome Measures

Name	Time	Method
Postoperative complications	1 month	The better way to fashion enterotomy closure

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy