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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Laparoscopy | Determine 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.