Zenker Diverticulum
Conditions
Keywords
LigaSure V (TM)
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.
Interventions
DEVICERepair w/LigaSure
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Temperature (°C) | baseling to Day 1 | — |
| Time until the patient restarts eating (hours) | Day 1 | — |
| Change in Deglutition Handicap Index score | baseline to Day 3 | — |
| Presence/absence of post-operative complications | Day 0 (day of surgery) | — |
| Change in weight | baseline to 6-8 weeks | Change in weight measured in kilograms |
| Change in visual analog scale for pain | baseline to day 1 | Visual analog scale varying from 0 to 10 |
Countries
France
Outcome results
None listed