Evaluation of Abdominal Wall Thickness at Possible Trocar Sites Based on Body Mass Index

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.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Procedure: Laparoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • University Physician's Grant's Ferry
    • Flowood, Mississippi, United States, 39232
      • University Physician's Women's Specialty Care
    • Jackson, Mississippi, United States, 39213
      • University's Physician Specialty Clinics Jackson Medical Mall
    • Jackson, Mississippi, United States, 39216
      • Winfred L. Wiser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients between the age of 18-64; BMI greater than 18.5

Exclusion Criteria:

• Abdominal hernias

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trocar Insertion Sites; 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.	Procedure: Laparoscopy; Determine best port sites to insert bariatric trocars; Other Names: Trocar Insertion Sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of abdominal wall depths	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)	Measurement of abdominal wall depth will occur during the surgical procedure

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Investigators: Principal Investigator: Elizabeth Lutz, MD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 14, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2015-0298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO