Impact of Marking Surgical Incision on Patient's Abdomen

NCT ID: NCT01803334

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-07-08

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.

Conditions

Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Marking abdomen

Intervention Type: OTHER

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AdventHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose A carugno, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

Florida Hospital

Orlando, Florida, United States

Countries

United States

Other Identifiers

322259

Identifier Type: -

Identifier Source: org_study_id