Clinical trial NCT01739426: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure
Official title: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Zenker Diverticulum
Keywords: LigaSure V (TM)
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operational success according to the van Overbeek classification (yes/no)
timeFrame: 12 months
measure: Change in Deglutition Handicap Index score
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Change in Deglutition Handicap Index score
timeFrame: baseline to Day 3
measure: Change in Deglutition Handicap Index score
timeFrame: baseline to 6-8 weeks
measure: Change in visual analog scale for pain
timeFrame: baseline to day 1
measure: Change in visual analog scale for pain
timeFrame: baseline to day 2
measure: Change in visual analog scale for pain
timeFrame: baseline to day 3
measure: Change in Temperature (°C)
timeFrame: baseling to Day 1
measure: Change in Temperature (°C)
timeFrame: baseling to Day 2
measure: Change in Temperature (°C)
timeFrame: baseling to Day 3
measure: Time until the patient restarts eating (hours)
timeFrame: Day 1
measure: Time until the patient restarts eating (hours)
timeFrame: Day 2
measure: Time until the patient restarts eating (hours)
timeFrame: Day 3
measure: Change in weight
timeFrame: baseline to 6-8 weeks
measure: Change in weight
timeFrame: baseline to 12 months
measure: Presence/absence of post-operative complications
timeFrame: Day 0 (day of surgery)
measure: Presence/absence of post-operative complications
timeFrame: Day 1
measure: Presence/absence of post-operative complications
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Sophie Kacha, MD
role: PRINCIPAL_INVESTIGATOR
References: