Open AccessPre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study Protocol for a Multicenter Randomized Controlled Trial
Author(s) -
Philip Müller,
Diana Vetter,
Joshua Kapp,
Christoph Gubler,
Bernhard Morell,
Dimitri Aristotle Raptis,
Christian A. Gutschow
Publication year - 2021
Publication title -
international journal of surgery protocols
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.291
H-Index - 4
ISSN - 2468-3574
DOI - 10.29337/ijsp.24
Subject(s) - medicine , randomized controlled trial , surgery , esophagectomy , clinical trial , protocol (science) , anastomosis , prospective cohort study , intention to treat analysis , general surgery , esophageal cancer , cancer , alternative medicine , pathology
Anastomotic leakage (AL) accounts for a significant proportion of morbidity following oesophagectomy. Endoluminal negative pressure (ENP) therapy via a specifically designed polyurethane foam (EsoSponge ® , B.Braun Medical, Melsungen, Germany) has become the standard of care for AL in many specialized centres. The prophylactic (pENP) application of this technique aims to reduce postoperative morbidity and is a novel approach which has not yet been investigated in a prospective study. The aim of this study is therefore to assess the effect of pENP at the anastomotic site in high-risk patients undergoing minimally invasive transthoracic Ivor Lewis oesophagectomy.