Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Marking Surgical Incision on Patient's Abdomen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01803334
Recruitment Status : Terminated (Not enough participants could be enrolled and so the PI decided to close the study. No participants completed the study)
First Posted : March 4, 2013
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
AdventHealth

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.

Condition or disease Intervention/treatment Phase
Surgical Procedure Other: Marking abdomen Not Applicable

Detailed Description:

This study is a prospective, randomized controlled trial examining the impact of marking the patient abdomen at the time of the preoperative visit on patient's satisfaction with scar appearance and symptoms, and pain at the incision site after undergoing minimally invasive gynecologic surgery for benign conditions.

We hypothesize that preoperative marking and instruction about incision expectations will improve patient's postoperative satisfaction with scar appearance and symptoms as well as decrease incision site pain compared to traditional preoperative counseling.

Patients that will undergo laparoscopic surgical intervention will be identified. The patient will be randomized into two groups: preoperative marking the abdomen versus conventional preoperative counseling.

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. If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.

After completed the surgery, information regarding type of surgery, reason for the procedure, estimated blood loss, surgical length, complications, location and size of abdominal incisions made on the patient's abdomen will be collected. Then at the 6 weeks post op visit, patient's satisfaction with the incision scar will be evaluated with a validated patient scar assessment questionnaire form and by one 5 point Likert scale question used in previous studies. The pain at rest at the incision site will be evaluated by a Visual Analog Pain Scale (VAS). Patients will also be asked to evaluate their generalized pain using a modified McGill Present Pain Intensity Scale.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Marking Surgical Incision Size and Location on the Patient's Abdomen During Preoperative Counseling in Minimally Invasive Gynecologic Surgery. A Randomized Control Trial.
Study Start Date : June 2012
Actual Primary Completion Date : July 8, 2013
Actual Study Completion Date : July 8, 2013

Arm Intervention/treatment
Experimental: Marking abdomen
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.
Other: Marking abdomen
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.

No Intervention: Control
If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.



Primary Outcome Measures :
  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. [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - 89
  2. Diagnosed with a benign surgical pathology
  3. Patient scheduled for elective minimally invasive gynecologic surgery

Exclusion Criteria:

  1. Have a diagnosis of gynecologic cancer
  2. History of prior laparoscopic surgery
  3. Emergency surgery
  4. Inability to provide informed consent
  5. Unable to follow up in the office for post operative visits
  6. Skin hypersensitivity or allergy to marker dye
  7. Positive pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803334


Locations
Layout table for location information
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32804
Sponsors and Collaborators
AdventHealth
Investigators
Layout table for investigator information
Principal Investigator: Jose A carugno, MD AdventHealth
Layout table for additonal information
Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT01803334    
Other Study ID Numbers: 322259
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Keywords provided by AdventHealth:
surgical incision
laparoscopy
pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Surgical Wound
Wounds and Injuries