The Umbilical Access in Laparoscopic Surgery

Not Applicable

Withdrawn

• Conditions: Scars; Patient Satisfaction; Cosmesis
• Interventions: Procedure: intraumbilical incision; Procedure: infraumbilical incision

• Registration Number: NCT01350739
• Lead Sponsor: St John of God Hospital, Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-08
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Study Start: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• patient undergoing laparoscopic surgery

Exclusion Criteria

• pregnancy
• patients following open abdominal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraumbilical incision	intraumbilical incision	an intraumbilical vertical incision is made
infraumbilical incision	infraumbilical incision	incision is done in circular fashion at the inferior boarder of umbilicus

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Surgery, St John of God Hospital; 🇦🇹 Vienna, Austria