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The Umbilical Access in Laparoscopic Surgery

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350739
First Posted: May 10, 2011
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna
  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: None (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 Bernhard Dauser, MD, St John of God Hospital, Vienna:

Primary Outcome Measures:
  • Scarring related to different accesses at the umbilicus [ Time Frame: 3, 12 months ]
    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 ]
    Appearance of the umbilical postoperatively and patient satisfaction with the operative results will be assessed by means of a Body Image Questionnaire (BIQ)


Enrollment: 0
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- patient undergoing laparoscopic surgery

Exclusion Criteria:

  • pregnancy
  • patients following open abdominal surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350739


Locations
Austria
Department of Surgery, St John of God Hospital
Vienna, Austria, 1020
Sponsors and Collaborators
St John of God Hospital, Vienna
Investigators
Principal Investigator: Bernhard Dauser, MD St John of God Hospital, Vienna
  More Information

Responsible Party: Bernhard Dauser, MD, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT01350739     History of Changes
Other Study ID Numbers: Umb11
First Submitted: May 8, 2011
First Posted: May 10, 2011
Last Update Posted: November 18, 2015
Last Verified: November 2015