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OpenTrials
Completed

NCT Number: NCT01739426

Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using LigaSure

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.

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Key information

Conditions

Zenker Diverticulum Digestive System Diseases Diverticular Diseases Diverticulum Diverticulum, Esophageal Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repair w/LigaSure

Device

Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)

Primary outcomes

  1. Operational success according to the van Overbeek classification (yes/no)

    Time frame: 12 months

  2. Change in Deglutition Handicap Index score

    Time frame: baseline to 12 months

Secondary outcomes

  1. Change in Deglutition Handicap Index score

    Time frame: baseline to Day 3

  2. Change in Deglutition Handicap Index score

    Time frame: baseline to 6-8 weeks

  3. Change in visual analog scale for pain

    Time frame: baseline to day 1

    Visual analog scale varying from 0 to 10

  4. Change in visual analog scale for pain

    Time frame: baseline to day 2

    Visual analog scale varying from 0 to 10

  5. Change in visual analog scale for pain

    Time frame: baseline to day 3

    Visual analog scale varying from 0 to 10

  6. Change in Temperature (°C)

    Time frame: baseling to Day 1

  7. Change in Temperature (°C)

    Time frame: baseling to Day 2

  8. Change in Temperature (°C)

    Time frame: baseling to Day 3

  9. Time until the patient restarts eating (hours)

    Time frame: Day 1

  10. Time until the patient restarts eating (hours)

    Time frame: Day 2

  11. Time until the patient restarts eating (hours)

    Time frame: Day 3

  12. Change in weight

    Time frame: baseline to 6-8 weeks

    Change in weight measured in kilograms

  13. Change in weight

    Time frame: baseline to 12 months

    Change in weight measured in kilograms

  14. Presence/absence of post-operative complications

    Time frame: Day 0 (day of surgery)

  15. Presence/absence of post-operative complications

    Time frame: Day 1

  16. Presence/absence of post-operative complications

    Time frame: 6-8 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System

Acronym: ZENKER LS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2012
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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