Study Stopped
Not enough participants could be enrolled and so the PI decided to close the study. No participants completed the study
Impact of Marking Surgical Incision on Patient's Abdomen
1 other identifier
interventional
4
1 country
1
Brief Summary
This is a study looking at patient's satisfaction with incision site and location after undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have the anticipated incision marked with a washable marker on their abdomen. The control group will have preoperative counselling as usual. After surgery, will assess patient's satisfaction with the incision scar.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 28, 2013
CompletedFirst Posted
Study publicly available on registry
March 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2013
CompletedSeptember 30, 2020
September 1, 2020
1.1 years
February 28, 2013
September 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient's expectation and satisfaction with incision scar will be evaluated with the patient scar assessment questionnaire and a 5 points Likert type scale question.
6 weeks
Study Arms (2)
Marking abdomen
EXPERIMENTALIf the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit.
Control
NO INTERVENTIONIf she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.
Interventions
If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit.
Eligibility Criteria
You may qualify if:
- Age 18 - 89
- Diagnosed with a benign surgical pathology
- Patient scheduled for elective minimally invasive gynecologic surgery
You may not qualify if:
- Have a diagnosis of gynecologic cancer
- History of prior laparoscopic surgery
- Emergency surgery
- Inability to provide informed consent
- Unable to follow up in the office for post operative visits
- Skin hypersensitivity or allergy to marker dye
- Positive pregnancy test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealthlead
Study Sites (1)
Florida Hospital
Orlando, Florida, 32804, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose A carugno, MD
AdventHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2013
First Posted
March 4, 2013
Study Start
June 1, 2012
Primary Completion
July 8, 2013
Study Completion
July 8, 2013
Last Updated
September 30, 2020
Record last verified: 2020-09