Suspended

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.

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What is being tested

Marking abdomen

Other
Who is being recruted

Neurologic Manifestations+3

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

From 18 to 89 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorAdventHealth
Last updated: September 30, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorAdventHealth
Last updated: September 30, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesSurgical WoundPain

Criteria

3 inclusion criteria required to participate
Age 18 - 89

Diagnosed with a benign surgical pathology

Patient scheduled for elective minimally invasive gynecologic surgery

7 exclusion criteria prevent from participating
Emergency surgery

Have a diagnosis of gynecologic cancer

History of prior laparoscopic surgery

Inability to provide informed consent

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Florida Hospital

Orlando, United StatesOpen Florida Hospital in Google Maps
SuspendedOne Study Center