NCT01350739

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
4 years until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

2.6 years

First QC Date

May 8, 2011

Last Update Submit

November 17, 2015

Conditions

ScarsPatient SatisfactionCosmesis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Patient satisfaction with scars

    3, 12 months

Study Arms (2)

intraumbilical incision

OTHER

an intraumbilical vertical incision is made

Procedure: intraumbilical incision

infraumbilical incision

OTHER

incision is done in circular fashion at the inferior boarder of umbilicus

Procedure: infraumbilical incision

Interventions

intraumbilical incisionPROCEDURE

vertical, intraumbilical incision

intraumbilical incision
infraumbilical incisionPROCEDURE

incision at the inferior boarder of the umbilicus, circular

infraumbilical incision

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- patient undergoing laparoscopic surgery

You may not qualify if:

  • pregnancy
  • patients following open abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, St John of God Hospital

Vienna, Vienna, 1020, Austria

Location

MeSH Terms

Conditions

CicatrixPatient Satisfaction

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bernhard Dauser, MD

    St John of God Hospital, Vienna

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 8, 2011

First Posted

May 10, 2011

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

AU(1)