Trials / Unknown
UnknownNCT04162860
Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy
Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University of Zurich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the preSponge randomized controlled trial (RCT) will be to assess the potential protective effects of preemptive endoscopic negative pressure therapy (ENP) on postoperative morbidity in high-risk patients undergoing total minimally invasive transthoracic esophagectomy with gastric pull-up reconstruction and high intrathoracic anastomosis (thoracoscopic and laparoscopic Ivor Lewis esophagectomy).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Eso-SPONGE® device | Preemptive ENP therapy will be carried out with either an Eso-SPONGE® device system (Eso-SPONGE®, B. Braun Melsungen AG, Melsungen, Germany). Eso-SPONGE® consists of an open-pored polyurethane foam fitted to a gastric tube. Secretions are then continuously evacuated using a suction pump generating a negative pressure between 75 and 100 mmHg. |
Timeline
- Start date
- 2019-12-04
- Primary completion
- 2020-12-01
- Completion
- 2021-03-01
- First posted
- 2019-11-14
- Last updated
- 2019-12-13
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04162860. Inclusion in this directory is not an endorsement.