Patient Satisfaction Clinical Trial
Official title:
Comparative, Randomized, Open-label Study: Different Incisions to Access the Abdominal Cavity Within the Umbilicus
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 |
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.
Status | Withdrawn |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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Austria | Department of Surgery, St John of God Hospital | Vienna |
Lead Sponsor | Collaborator |
---|---|
St John of God Hospital, Vienna |
Austria,
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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