Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery

NCT02574013 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2019-05-30

No results posted yet for this study

Summary

To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in Trendelenburg position. This position results in hemodynamic changes which may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as alternative for the Trendelenburg position during laparoscopic surgery.

Conditions

Interventions

DEVICE

Endoractor®

Endoscopic sponge for retraction of small intestine

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Anke B Smits, MD PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-08-31
Completion
2020-12-31

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02574013 on ClinicalTrials.gov