ScarsNCT01350739
The Umbilical Access in Laparoscopic Surgery
A study testing intraumbilical incision and infraumbilical incision in people with Scars and Patient Satisfaction, run by St John of God Hospital, Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Scars, Patient Satisfaction, Cosmesis
- What is being tested?
- intraumbilical incision and infraumbilical incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- May 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing laparoscopic surgery
Who cannot join
- pregnancy
- patients following open abdominal surgery
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Surgery, St John of God Hospital
Vienna, State of Vienna, 1020
About this study
Official title: Comparative, Randomized, Open-label Study: Different Incisions to Access the Abdominal Cavity Within the Umbilicus
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.
- Conditions
- Scars, Patient Satisfaction, Cosmesis
- Being tested
- intraumbilical incision, infraumbilical incision
- Medical subject headings
- Cicatrix, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraumbilical incisionProcedure or surgery
vertical, intraumbilical incision
infraumbilical incisionProcedure or surgery
incision at the inferior boarder of the umbilicus, circular
| Study group | Role | What they receive |
|---|---|---|
| intraumbilical incision | Other | an intraumbilical vertical incision is made Receives: Procedure: intraumbilical incision |
| infraumbilical incision | Other | incision is done in circular fashion at the inferior boarder of umbilicus Receives: Procedure: infraumbilical incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scarring related to different accesses at the umbilicus
Appearance of scars will be assessed by means of the Manchester Scar Scale (MSS)
Measured: 3, 12 months
Secondary outcomes (1)
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)
Measured: 3, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St John of God Hospital, Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Dauser, MD, St John of God Hospital, Vienna
- Investigators
- Bernhard Dauser, MD, Principal investigator, St John of God Hospital, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350739
- Sponsor's protocol ID
- Umb11
- Status last verified
- Nov 2015
- First submitted
- 8 May 2011
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Open-label Study: Different Incisions to Access the Abdominal Cavity Within the Umbilicus
- ClinicalTrials.gov ID
- NCT01350739
- Acronym / sponsor ID
- Umb11
- Conditions
- Scars, Patient Satisfaction, Cosmesis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St John of God Hospital, ViennaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraumbilical incision | Other | Procedure: intraumbilical incisionan intraumbilical vertical incision is made |
| infraumbilical incision | Other | Procedure: infraumbilical incisionincision is done in circular fashion at the inferior boarder of umbilicus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing laparoscopic surgery
Key exclusion criteria (2 listed)
- pregnancy
- patients following open abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraumbilical incisionvertical, intraumbilical incision | Procedure or surgery | intraumbilical incision |
| infraumbilical incisionincision at the inferior boarder of the umbilicus, circular | Procedure or surgery | infraumbilical incision |
Primary outcome
Scarring related to different accesses at the umbilicus
Time frame: 3, 12 months
Appearance of scars will be assessed by means of the Manchester Scar Scale (MSS)
1 secondary outcome
Patient satisfaction with scars
Time frame: 3, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Dauser, MD principal investigator
St John of God Hospital, Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraumbilical incision and infraumbilical incision in people with Scars and Patient Satisfaction, run by St John of God Hospital, Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scarring related to different accesses at the umbilicus (time frame: 3, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.