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The Umbilical Access in Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01350739
Recruitment Status : Withdrawn
First Posted : May 10, 2011
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bernhard Dauser, MD, St John of God Hospital, Vienna

Brief Summary:

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 or disease Intervention/treatment
Scars Patient Satisfaction Cosmesis Procedure: intraumbilical incision Procedure: infraumbilical incision

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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)



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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

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

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 Posted: May 10, 2011    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015