Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure (ZENKER LS)
Primary Purpose
Zenker Diverticulum
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Repair w/LigaSure
Sponsored by
About this trial
This is an interventional treatment trial for Zenker Diverticulum focused on measuring LigaSure V (TM)
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
Sites / Locations
- CHU de Nîmes - Hôpital Universitaire Carémeau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study population
Arm Description
The population is composed of patients with a confirmed Zenker's diverticulum. Intervention: Repair w/LigaSure
Outcomes
Primary Outcome Measures
Operational success according to the van Overbeek classification (yes/no)
Change in Deglutition Handicap Index score
Secondary Outcome Measures
Change in Deglutition Handicap Index score
Change in Deglutition Handicap Index score
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Change in visual analog scale for pain
Visual analog scale varying from 0 to 10
Change in Temperature (°C)
Change in Temperature (°C)
Change in Temperature (°C)
Time until the patient restarts eating (hours)
Time until the patient restarts eating (hours)
Time until the patient restarts eating (hours)
Change in weight
Change in weight measured in kilograms
Change in weight
Change in weight measured in kilograms
Presence/absence of post-operative complications
Presence/absence of post-operative complications
Presence/absence of post-operative complications
Full Information
NCT ID
NCT01739426
First Posted
November 28, 2012
Last Updated
October 21, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01739426
Brief Title
Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure
Acronym
ZENKER LS
Official Title
Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zenker Diverticulum
Keywords
LigaSure V (TM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study population
Arm Type
Experimental
Arm Description
The population is composed of patients with a confirmed Zenker's diverticulum.
Intervention: Repair w/LigaSure
Intervention Type
Device
Intervention Name(s)
Repair w/LigaSure
Intervention Description
Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)
Primary Outcome Measure Information:
Title
Operational success according to the van Overbeek classification (yes/no)
Time Frame
12 months
Title
Change in Deglutition Handicap Index score
Time Frame
baseline to 12 months
Secondary Outcome Measure Information:
Title
Change in Deglutition Handicap Index score
Time Frame
baseline to Day 3
Title
Change in Deglutition Handicap Index score
Time Frame
baseline to 6-8 weeks
Title
Change in visual analog scale for pain
Description
Visual analog scale varying from 0 to 10
Time Frame
baseline to day 1
Title
Change in visual analog scale for pain
Description
Visual analog scale varying from 0 to 10
Time Frame
baseline to day 2
Title
Change in visual analog scale for pain
Description
Visual analog scale varying from 0 to 10
Time Frame
baseline to day 3
Title
Change in Temperature (°C)
Time Frame
baseling to Day 1
Title
Change in Temperature (°C)
Time Frame
baseling to Day 2
Title
Change in Temperature (°C)
Time Frame
baseling to Day 3
Title
Time until the patient restarts eating (hours)
Time Frame
Day 1
Title
Time until the patient restarts eating (hours)
Time Frame
Day 2
Title
Time until the patient restarts eating (hours)
Time Frame
Day 3
Title
Change in weight
Description
Change in weight measured in kilograms
Time Frame
baseline to 6-8 weeks
Title
Change in weight
Description
Change in weight measured in kilograms
Time Frame
baseline to 12 months
Title
Presence/absence of post-operative complications
Time Frame
Day 0 (day of surgery)
Title
Presence/absence of post-operative complications
Time Frame
Day 1
Title
Presence/absence of post-operative complications
Time Frame
6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Kacha, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
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Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure
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