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

NCT ID: NCT02712216

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-10-31

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.

Conditions

Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Laparoscopy

Intervention Type: PROCEDURE

Determine best port sites to insert bariatric trocars

Interventions

Laparoscopy

Determine best port sites to insert bariatric trocars

Intervention Type: PROCEDURE

Other Intervention Names

Trocar Insertion Sites

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Abdominal hernias

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Lutz

Assistant Professor Obstetrics-Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Lutz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University Physician's Grant's Ferry

Flowood, Mississippi, United States

University Physician's Women's Specialty Care

Flowood, Mississippi, United States

University's Physician Specialty Clinics Jackson Medical Mall

Jackson, Mississippi, United States

Winfred L. Wiser

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

2015-0298

Identifier Type: -

Identifier Source: org_study_id