The Umbilical Access in Laparoscopic Surgery

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01350739

Enrollment

Registered

2011-05-10

Start date

2015-05-31

Completion date

2017-12-31

Last updated

2015-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cosmesis, Patient Satisfaction, Scars

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.

Interventions

PROCEDUREintraumbilical incision

vertical, intraumbilical incision

PROCEDUREinfraumbilical incision

incision at the inferior boarder of the umbilicus, circular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

\- patient undergoing laparoscopic surgery

Exclusion criteria

* pregnancy * patients following open abdominal surgery

Design outcomes

Primary

Measure	Time frame	Description
Scarring related to different accesses at the umbilicus	3, 12 months	Appearance of scars will be assessed by means of the Manchester Scar Scale (MSS)

Secondary

Measure	Time frame	Description
Patient satisfaction with scars	3, 12 months	Appearance of the umbilical postoperatively and patient satisfaction with the operative results will be assessed by means of a Body Image Questionnaire (BIQ)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026