Impact of Marking Surgical Incision on Patient's Abdomen

AdventHealth

Status: Terminated

Conditions: Surgical Procedure

Treatments: Other: Marking abdomen

Study type: Interventional

Funder types: Other

Identifiers

NCT01803334

322259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

4 participants in 2 patient groups

Marking abdomen

Experimental group

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.

Treatment:

Other: Marking abdomen

Control

No Intervention group

Description:

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