Traxi Panniculus Retractor for Cesarean Delivery

Status Recruiting

Clinical Trial Summary

This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.

Clinical Trial Description

Morbidly obese women (BMI >/= 40) undergoing non-emergent cesarean delivery will be recruited and randomized to Traxi panniculus retraction or standard of care for panniculus retraction. The primary outcome evaluated will be operating time (incision to closure). Other secondary outcomes related to surgery including estimated blood loss, surgical site infection, and number of scrubbed personnel. A secondary aim of the study is to evaluate the hypothesis that the Traxi retraction device reduces chestwall compression panniculus retraction and will improve intraoperative pulmonary function. To do this, the investigators will measure the difference in individual participant pulmonary function tests (forced vital capacity, forced expiratory volume) before and after panniculus retraction using a bedside spirometer. A tertiary aim of the study is to evaluate the hypothesis that the Traxi retraction device will improve patient and provider satisfaction due to improved delivery experience and maintaining patient dignity. Patient and provider-reported outcomes will be evaluated using surveys. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03651076
Study type	Interventional
Source	Beth Israel Deaconess Medical Center
Contact	Ai-ris Y Collier, MD
Phone	6176671726
Email	acollier@bidmc.harvard.edu
Status	Recruiting
Phase	N/A
Start date	October 2, 2018
Completion date	May 2025

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04517591` - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study	N/A
Active, not recruiting	`NCT04583683` - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities	N/A
Completed	`NCT01550601` - Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity	N/A
Completed	`NCT03638843` - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2	N/A
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Completed	`NCT03339791` - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial	N/A
Recruiting	`NCT05711758` - Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Not yet recruiting	`NCT04209842` - Effectiveness Gastric Balloon in Obese Adolescents	N/A
Recruiting	`NCT03100292` - Korean OBEsity Surgical Treatment Study	N/A
Active, not recruiting	`NCT04357119` - Common Limb Length in One-anastomosis Gastric Bypass	N/A
Completed	`NCT03210207` - Gastric Plication in Mexican Patients	N/A
Completed	`NCT02590406` - EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation	N/A
Completed	`NCT01840020` - BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Completed	`NCT01183975` - Swedish Adjustable Gastric Banding Observational Cohort Study	N/A
Completed	`NCT03872024` - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients	N/A
Terminated	`NCT05993169` - Body Composition Optimization Intervention RCT	N/A
Not yet recruiting	`NCT05974995` - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer	N/A
Recruiting	`NCT05554016` - The UFO (Ultra Processed Foods in Obesity) Project
Completed	`NCT05519423` - Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals	N/A
Not yet recruiting	`NCT05499949` - The Franciscus Obesity NASH Study