Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure (ZENKER LS)

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Zenker Diverticulum

Treatments

Device: Repair w/LigaSure

Study type

Interventional

Funder types

Other

Identifiers

NCT01739426

LOCAL/2012/SK-02

2012-A01096-37 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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