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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Operational success according to the van Overbeek classification (yes/no)
Time frame: 12 months
Change in Deglutition Handicap Index score
Time frame: baseline to 12 months
Change in Deglutition Handicap Index score
Time frame: baseline to Day 3
Change in Deglutition Handicap Index score
Time frame: baseline to 6-8 weeks
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Time frame: baseline to day 1
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Time frame: baseline to day 2
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Time frame: baseline to day 3
Change in Temperature (°C)
Time frame: baseling to Day 1
Change in Temperature (°C)
Time frame: baseling to Day 2
Change in Temperature (°C)
Time frame: baseling to Day 3
Time until the patient restarts eating (hours)
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Time frame: Day 1
Time until the patient restarts eating (hours)
Time frame: Day 2
Time until the patient restarts eating (hours)
Time frame: Day 3
Change in weight
Change in weight measured in kilograms
Time frame: baseline to 6-8 weeks
Change in weight
Change in weight measured in kilograms
Time frame: baseline to 12 months
Presence/absence of post-operative complications
Time frame: Day 0 (day of surgery)
Presence/absence of post-operative complications
Time frame: Day 1
Presence/absence of post-operative complications
Time frame: 6-8 weeks