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