ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00009447
Date of registration:	27/10/2015
Prospective Registration:	Yes
Primary sponsor:	Medizinische Universität Wien
Public title:	Hemodynamic implications of laparoscopic surgery in Neonates and Infants compared to the open approach
Scientific title:	Hemodynamic implications of laparoscopic surgery in Neonates and Infants compared to the open approach - LiDCOlapScop
Date of first enrolment:	01/01/2016
Target sample size:	20
Recruitment status:	Pending
URL:	http://drks.de/search/en/trial/DRKS00009447
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Austria

Contacts

Name:	Triffterer Lydia
Address:	Spitalgasse 23 1090 Wien Austria
Telephone:	0043 1 40400 4100
Email:	lydia.triffterer@meduniwien.ac.at
Affiliation:	Medizinische Universität Wien

Name:	Werner Schmid
Address:	Währinger-Gürtel 18-20 1090 Wien Austria
Telephone:	01 40400 19231
Email:	werner.schmid@meduniwien.ac.at
Affiliation:	Medizinische Universität Wien

Key inclusion & exclusion criteria

Inclusion criteria: Major abdominal surgery, laparoscopic or open approach, in Neonates and infants (aged = 1 year)
Exclusion criteria: Parent's refusal of participation of their child in the study

Age minimum: 0 Months
Age maximum: 12 Months
Gender: All

Health Condition(s) or Problem(s) studied

Hemodynamic implications of laparoscopic surgery

Intervention(s)

Group 1: Hemodynamic parameters during open abdominal surgery.
Group 2: Hemodynamic parameters during laparoscopic surgery.

Primary Outcome(s)

To describe the hemodynamic changes (via LIDCO) in Neonates and infants compared in laparoscopic versus open approach

Secondary Outcome(s)

There are respiratory changes while mechanical ventilation (VT;PIP) in patients with laparoscopic surgery

Secondary ID(s)

Source(s) of Monetary Support

Anästhesie, Allgemiene Intensivmedizin und Schmerztherapie

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 02/10/2015
Contact:

ethik-kom@meduniwien.ac.at

Ethikkommission der Medizinischen Universität Wien

(+43)1-40400-21470

ethik-kom@meduniwien.ac.at

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00009447#studyResults

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.