The Umbilical Access in Laparoscopic Surgery

This study has been withdrawn prior to enrollment.
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: November 17, 2015
Last verified: November 2015
  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)


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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

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 
Study First Received: May 8, 2011
Last Updated: November 17, 2015
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on August 25, 2016