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NCT01350739 Clinical Trial

The Umbilical Access in Laparoscopic Surgery

Patient Satisfaction Clinical Trial

Official title:
Comparative, Randomized, Open-label Study: Different Incisions to Access the Abdominal Cavity Within the Umbilicus

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01350739
Other study ID # Umb11
Secondary ID
Status Withdrawn
Phase N/A
First received May 8, 2011
Last updated November 17, 2015
Start date May 2015
Est. completion date December 2017

Study information
Verified date November 2015
Source St John of God Hospital, Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patient undergoing laparoscopic surgery

Exclusion Criteria:

- pregnancy

- patients following open abdominal surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Procedure:
• intraumbilical incision
vertical, intraumbilical incision
• infraumbilical incision
incision at the inferior boarder of the umbilicus, circular

Locations
Country Name City State
Austria Department of Surgery, St John of God Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
St John of God Hospital, Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Scarring related to different accesses at the umbilicus Appearance of scars will be assessed by means of the Manchester Scar Scale (MSS) 3, 12 months No
Secondary Patient satisfaction with scars Appearance of the umbilical postoperatively and patient satisfaction with the operative results will be assessed by means of a Body Image Questionnaire (BIQ) 3, 12 months No
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