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Impact of Marking Surgical Incision on Patient's Abdomen

Primary Purpose

Surgical Procedure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marking abdomen
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Procedure focused on measuring surgical incision, laparoscopy, pain

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Marking abdomen

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2013
Last Updated
September 28, 2020
Sponsor
AdventHealth
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1. Study Identification

Unique Protocol Identification Number
NCT01803334
Brief Title
Impact of Marking Surgical Incision on Patient's Abdomen
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants could be enrolled and so the PI decided to close the study. No participants completed the study
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 8, 2013 (Actual)
Study Completion Date
July 8, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Procedure
Keywords
surgical incision, laparoscopy, pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marking abdomen
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.
Intervention Type
Other
Intervention Name(s)
Marking abdomen
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 89 Diagnosed with a benign surgical pathology Patient scheduled for elective minimally invasive gynecologic surgery Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A carugno, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States

12. IPD Sharing Statement

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Impact of Marking Surgical Incision on Patient's Abdomen

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