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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
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.
University Hospital Zurich
Zurich, Switzerland
RECRUITINGLength of hospital stay until "fit-for-discharge" criteria are reached
* The patients' oral/enteral nutritional requirements are met by oral intake of at least liquids with optional supplementary nutrition via jejunal feeding tube. * The patient should have passed flatus. * The patient does not require oxygen during mobilisation (short walk or climbing stairs) or at rest. * Central venous catheters should be removed before discharge (unless present preoperatively). * Adequate analgesia at rest and during mobilisation (pain score \<4 on a scale from 0 to 10) is achieved using both oral opioid and non-opioid analgesics. * All vital signs should be normal unless abnormal preoperatively. * Inflammatory parameters (white cell count, C-reactive protein) should be trending down and close to normal. * There should be adequate support after discharge (assistance by family, ambulatory nursing, or rehabilitation facility).
Time frame: 90-days postoperatively
Postoperative Complications
Assessment of postoperative complications according to Clavien-Dindo
Time frame: 90-days postoperatively
Postoperative Complications
Hospital readmissions
Time frame: 90-days postoperatively
Postoperative Complications
Anastomotic stricture
Time frame: 90-days postoperatively
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