Retrospective Study of Endoscopic Ultrasound (EUS) Guided Transmural Drainage of Post-operative Abdominal Collections

Completed

• Conditions: Post-surgical Intra-abdominal Collection
• Interventions: Procedure: EUS guided transmural drainage

• Registration Number: NCT01537848
• Lead Sponsor: Erasme University Hospital

Brief Summary

This is a retrospective study of a single center on endoscopic ultrasound (EUS) guided transmural drainage of post-operative collections during a 9 years period.

Detailed Description

All patients who underwent a EUS guided drainage of post-operative collection between 2002 and 2011 in the endoscopy unit of Erasme hospital will be included for analysis. The study will focus on retrospective analysis of prospectively collected data. The technique is the same as the one used for pancreatic pseudocysts drainage. The technical success is defined as the ability to access and drain the collection by placement of transmural drain and/or stents. Treatment success (regression of collection) is defined as the resolution of the collection as shown on abdominal imaging (CT or MRI) in association with clinical resolution of symptoms at 8 weeks of follow-up.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2011-07
• Status Verified: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-23
• Last Update Submitted: 2012-02-23
• Last Update Posted: 2012-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• All patients who underwent EUS guided drainage of post-operative collections admitted between january 2002 and july 2011 for this treatment in the endoscopic department of a single academic center will be included for analysis.

Exclusion Criteria

• none (patients for whom other modalities of fluid drainage failed were also included in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post-operative collection	EUS guided transmural drainage	patients suffering from a post-operative abdominal collection

Primary Outcome Measures

Name	Time	Method
Treatment success	8 weeks after treatment	Regression of collection = resolution of collection as shown on abdominal imaging (Ct or MRI) in association with clinical resolution of symptoms at 8 weeks of follow-up

Secondary Outcome Measures

Name	Time	Method
technical success	day of procedure (day 1)	Success to access and drain the collection by the placement of transmural drain and/or stent(s)

Trial Locations

Locations (1)

Erasme Hospital, Gastroenterology Department, ULB (Université libre de Bruxelles); 🇧🇪 Brussels, Belgium