Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01096-37 | Other Identifier | RCB number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Experimental | The population is composed of patients with a confirmed Zenker's diverticulum. Intervention: Repair w/LigaSure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operational success according to the van Overbeek classification (yes/no) | 12 months | |
| Change in Deglutition Handicap Index score | baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Deglutition Handicap Index score | baseline to Day 3 | |
| Change in Deglutition Handicap Index score | baseline to 6-8 weeks | |
| Change in visual analog scale for pain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sophie Kacha, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
Not provided
| ID | Term |
|---|---|
| D016672 | Zenker Diverticulum |
| ID | Term |
|---|---|
| D004936 | Diverticulum, Esophageal |
| D004240 | Diverticulum |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Visual analog scale varying from 0 to 10 |
| baseline to day 1 |
| Change in visual analog scale for pain | Visual analog scale varying from 0 to 10 | baseline to day 2 |
| Change in visual analog scale for pain | Visual analog scale varying from 0 to 10 | baseline to day 3 |
| Change in Temperature (°C) | baseling to Day 1 |
| Change in Temperature (°C) | baseling to Day 2 |
| Change in Temperature (°C) | baseling to Day 3 |
| Time until the patient restarts eating (hours) | Day 1 |
| Time until the patient restarts eating (hours) | Day 2 |
| Time until the patient restarts eating (hours) | Day 3 |
| Change in weight | Change in weight measured in kilograms | baseline to 6-8 weeks |
| Change in weight | Change in weight measured in kilograms | baseline to 12 months |
| Presence/absence of post-operative complications | Day 0 (day of surgery) |
| Presence/absence of post-operative complications | Day 1 |
| Presence/absence of post-operative complications | 6-8 weeks |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |