Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02712216
Enrollment
50
Registered
2016-03-18
Start date
2016-02-29
Completion date
2016-10-31
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

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.

Interventions

PROCEDURELaparoscopy

Determine best port sites to insert bariatric trocars

Sponsors

University of Mississippi Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Abdominal hernias

Design outcomes

Primary

MeasureTime frameDescription
Measurement of abdominal wall depthsMeasurement of abdominal wall depth will occur during the surgical procedureThe 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026