Evaluation of Abdominal Wall Thickness at Possible Trocar Sites Based on Body Mass Index
- Conditions
- Surgery
- Interventions
- Procedure: Laparoscopy
- Registration Number
- NCT02712216
- Lead Sponsor
- University of Mississippi Medical Center
- Brief Summary
The purpose of this research study is to determine which sites are best suited for laparoscopic entry of bariatric trocars in the morbidly obese population.
- Detailed Description
Patients already scheduled for laparoscopy will be approached for participation prior to surgery. During laparoscopy, the investigators routinely inject port sites with a 21-gauge needle and inject sites with local anesthetic prior to trocar placement. In the study the investigators will insert a 21-gauge 3.5inch spinal needle perpendicular to the abdominal wall at each possible trocar site. The seven insertion sites are the umbilicus; 12cm lateral to umbilicus on right; 12cm lateral to umbilicus on left; Left lower quadrant lateral to inferior epigastric; Right lower quadrant lateral to inferior epigastric, Lower midline of abdomen; Left upper quadrant at Palmer's Point. The needle will be placed after the abdomen is insufflated under direct visualization with the laparoscopic camera. The needle will be inserted to the level of the peritoneum and a hemostat will be place on the needle at the level of the epidermis. The abdominal wall thickness will be measured with a ruler and recorded to the nearest millimeter. The information will be recorded on the case report form attached. The case report form will be kept in a binder in the research coordinators office.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- Patients between the age of 18-64; BMI greater than 18.5
- Abdominal hernias
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trocar Insertion Sites Laparoscopy Insertion of a 21-gauge 3.5inch spinal needle perpendicular to the abdominal wall at each possible trocar site. The needle will be placed after the abdomen is insufflated under direct visualization with the laparoscopic camera. The needle will be inserted to the level of the peritoneum and a hemostat will be place on the needle at the level of the epidermis.
- Primary Outcome Measures
Name Time Method Measurement of abdominal wall depths Measurement of abdominal wall depth will occur during the surgical procedure The measurement will be evaluated based on the following BMI categories: BMI 18.5-24.9 (normal weight) BMI 25-29.9 (overweight) BMI 30-34.9 (class 1 obesity) BMI 35-39.9 (class 2 obesity) BMI \>40 (class 3 obesity)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University's Physician Specialty Clinics Jackson Medical Mall
🇺🇸Jackson, Mississippi, United States
Winfred L. Wiser
🇺🇸Jackson, Mississippi, United States
University Physician's Grant's Ferry
🇺🇸Flowood, Mississippi, United States
University Physician's Women's Specialty Care
🇺🇸Flowood, Mississippi, United States