The Umbilical Access in Laparoscopic Surgery

This study is not yet open for participant recruitment.
Verified December 2013 by St John of God Hospital, Vienna
Sponsor:
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier:
NCT01350739
First received: May 8, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The aim of this study is to access to the abdominal cavity using different incision-types within the umbilical area.

Effects of different incisions on scarring and on the umbilical form will be investigated.


Condition Intervention
Scars
Patient Satisfaction
Cosmesis
Procedure: intraumbilical incision
Procedure: infraumbilical incision

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Open-label Study: Different Incisions to Access the Abdominal Cavity Within the Umbilicus

Resource links provided by NLM:


Further study details as provided by St John of God Hospital, Vienna:

Primary Outcome Measures:
  • Scarring related to different accesses at the umbilicus [ Time Frame: 3, 12 months ] [ Designated as safety issue: No ]
    Appearance of scars will be assessed by means of the Manchester Scar Scale (MSS)


Secondary Outcome Measures:
  • Patient satisfaction with scars [ Time Frame: 3, 12 months ] [ Designated as safety issue: No ]
    Appearance of the umbilical postoperatively and patient satisfaction with the operative results will be assessed by means of a Body Image Questionnaire (BIQ)


Estimated Enrollment: 60
Study Start Date: May 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
intraumbilical incision
an intraumbilical vertical incision is made
Procedure: intraumbilical incision
vertical, intraumbilical incision
infraumbilical incision
incision is done in circular fashion at the inferior boarder of umbilicus
Procedure: infraumbilical incision
incision at the inferior boarder of the umbilicus, circular

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- patient undergoing laparoscopic surgery

Exclusion Criteria:

  • pregnancy
  • patients following open abdominal surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350739

Contacts
Contact: Bernhard Dauser, MD +43 21121 ext 5098 bernhard.dauser@hotmail.com
Contact: Friedrich Herbst, MD, FRCS +43 21121 ext 3250 friedrich.herbst@bbwien.at

Locations
Austria
Department of Surgery, St John of God Hospital Not yet recruiting
Vienna, Austria, 1020
Contact: Paula Heichinger    +4321121 ext 3250    abteilung.chirurgie@bbwien.at   
Sponsors and Collaborators
St John of God Hospital, Vienna
Investigators
Principal Investigator: Bernhard Dauser, MD St John of God Hospital, Vienna
  More Information

No publications provided

Responsible Party: Bernhard Dauser, MD, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT01350739     History of Changes
Other Study ID Numbers: Umb11
Study First Received: May 8, 2011
Last Updated: December 11, 2013
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014