Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure
NCT ID: NCT01739426
Last Updated: 2015-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2013-03-31
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study population
The population is composed of patients with a confirmed Zenker's diverticulum.
Intervention: Repair w/LigaSure
Repair w/LigaSure
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)
Interventions
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Repair w/LigaSure
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Sophie Kacha, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , France
Countries
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Other Identifiers
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2012-A01096-37
Identifier Type: OTHER
Identifier Source: secondary_id
LOCAL/2012/SK-02
Identifier Type: -
Identifier Source: org_study_id
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