Clinical Trial: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System
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 Summary:
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.
Sponsor: Centre Hospitalier Universitaire de Nīmes
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 [ Time Frame: baseline to day 1 ]Visual analog scale varying from 0 to 10
- Change in visual analog scale for pain [ Time Frame: baseline to day 2 ]Visual analog scale varying from 0 to 10
- Change in visual analog scale for pain [ Time Frame: baseline to day 3 ]Visual analog scale varying from 0 to 10
- 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) [ 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 [ Time Frame: baseline to 6-8 weeks ]Change in weight measured in kilograms
- Change in weight [ Time Frame: baseline to 12 months ]Change in weight measured in kilograms
- 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 ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire de Nīmes
Dates:
Date Received: November 28, 2012
Date Started: March 2013
Date Completion:
Last Updated: October 21, 2015
Last Verified: October 2015