Clinical Trials Directory

Trials / Completed

CompletedNCT02712216

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
University of Mississippi Medical Center · Academic / Other
Sex
Female
Age
18 Years – 64 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELaparoscopyDetermine best port sites to insert bariatric trocars

Timeline

Start date
2016-02-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2016-03-18
Last updated
2018-09-06

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02712216. Inclusion in this directory is not an endorsement.