The Umbilical Access in Laparoscopic Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014