Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure

Not Applicable

Completed

• Conditions: Zenker Diverticulum
• Interventions: Device: Repair w/LigaSure

• Registration Number: NCT01739426
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.

Detailed Description

Our secondary objectives are:

A. To evaluate short-term (pain, fever, time to start of eating) and medium-term (weight, swallowing) post-operative parameters.

B. To evaluate the prevalence of post-operative complications.

Study Timeline

• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-03
• Study Start: 2013-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 12 months of follow-up
• The patient has a Zenkers diverticulum as confirmed by a pharyngo-oesophagean transit test, regardless of van Overbeek classification

Exclusion Criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient (or his/her person-of-trust) refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient does not read french
• The patient is pregnant
• The patient is breastfeeding
• The patients has a contraindication for a treatment necessary for this study, or for general anesthesia
• The patent has a history of complications related to hemostasis
• The preoperative checkup indicates potential for hemostasis related problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population	Repair w/LigaSure	The population is composed of patients with a confirmed Zenker's diverticulum. Intervention: Repair w/LigaSure

Primary Outcome Measures

Name	Time	Method
Operational success according to the van Overbeek classification (yes/no)	12 months
Change in Deglutition Handicap Index score	baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Deglutition Handicap Index score	baseline to 6-8 weeks
Time until the patient restarts eating (hours)	Day 3
Change in Temperature (°C)	baseling to Day 3
Change in visual analog scale for pain	baseline to day 3	Visual analog scale varying from 0 to 10
Presence/absence of post-operative complications	6-8 weeks
Change in weight	baseline to 12 months	Change in weight measured in kilograms

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France