NCT02712216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

March 4, 2016

Last Update Submit

September 5, 2018

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Trocar Insertion Sites

OTHER

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

Interventions

LaparoscopyPROCEDURE

Determine best port sites to insert bariatric trocars

Also known as: Trocar Insertion Sites
Trocar Insertion Sites

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Abdominal hernias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Physician's Grant's Ferry

Flowood, Mississippi, 39232, United States

Location

University Physician's Women's Specialty Care

Flowood, Mississippi, 39232, United States

Location

University's Physician Specialty Clinics Jackson Medical Mall

Jackson, Mississippi, 39213, United States

Location

Winfred L. Wiser

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Elizabeth Lutz, MD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Obstetrics-Gynecology

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 18, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(4)