Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System

Conditions
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Zenker Diverticulum

Intervention / Treatment
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* Device: Repair w/LigaSure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study population<br>The population is composed of patients with a confirmed Zenker's diverticulum. Intervention: Repair w/LigaSure | Device: Repair w/LigaSure<br>* Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Deglutition Handicap Index score |  | baseline to Day 3 | 
| Change in Deglutition Handicap Index score |  | baseline to 6-8 weeks | 
| Change in visual analog scale for pain | Visual analog scale varying from 0 to 10 | baseline to day 1 | 
| Change in visual analog scale for pain | Visual analog scale varying from 0 to 10 | baseline to day 2 | 
| Change in visual analog scale for pain | Visual analog scale varying from 0 to 10 | baseline to day 3 | 
| Change in Temperature (°C) |  | baseling to Day 1 | 
| Change in Temperature (°C) |  | baseling to Day 2 | 
| Change in Temperature (°C) |  | baseling to Day 3 | 
| Time until the patient restarts eating (hours) |  | Day 1 | 
| Time until the patient restarts eating (hours) |  | Day 2 | 
| Time until the patient restarts eating (hours) |  | Day 3 | 
| Change in weight | Change in weight measured in kilograms | baseline to 6-8 weeks | 
| Change in weight | Change in weight measured in kilograms | baseline to 12 months | 
| Presence/absence of post-operative complications |  | Day 0 (day of surgery) | 
| Presence/absence of post-operative complications |  | Day 1 | 
| Presence/absence of post-operative complications |  | 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LigaSure V (TM)