Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients

August 13, 2018 updated by: Wake Forest University

Patients with morbid obesity often develop a significant overhanging abdominal pannus. Problems associated with an overhanging pannus can include difficulty performing routine daily activities as well as exercise due to the cumbersome nature of the excess tissue. In addition, the abdominal pannus tissue often becomes infected due to difficulty with hygiene and abnormal circulation and lymphatic flow. There may also be a significant contribution from the pannus to the patient's underlying cardiopulmonary status which is often compromised in morbid obesity patients.

In addition to weight loss, one of the treatment strategies includes a panniculectomy. A panniculectomy involves resection of the excess abdominal skin and fat in a wedge shape from the lower abdomen. Purported benefits include increased ability to exercise, better quality of life and improved cardiopulmonary function. However, there is a significant morbidity associated with panniculectomy surgery, with wound related complications occurring in as much as 50% of patients with this procedure.

The investigators hypothesize that the panniculectomy procedure provides long term benefits to this patient population despite significant short term morbidity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective trial to determine what if any functional and quality of life benefits are achieved with a panniculectomy. Patients will be evaluated preoperatively and postoperatively with specific interventions aimed at describing their functional status. These interventions will include: echocardiogram, pulmonary function testing, arterial blood gas, functional capacity evaluation by physical therapy, and a quality of life survey. The investigative interventions will be performed postoperatively at 6 months and again at 1 year post surgery. Data will also be gathered on complications such as wound infection, dehiscence, and cardiopulmonary problems.

There should be no additional risk to the patient as the surgery and procedures listed are already performed routinely on this patient population.

Study participants will have morbid obesity with significant overhanging pannus that requires surgical intervention.

This study will compare the preoperative values to post operative values taken at 6 months and then at 1 year post operative. These values include echocardiograms, pulmonary function tests, arterial blood gases and a functional capacity evaluation.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be between the ages of 18 - 80 years of age
  • BMI > 35
  • non-smoker

Exclusion Criteria:

  • Subjects under the age of 18 or older than 80 years of age
  • BMI < 35 are not eligible for study inclusion
  • smokers are not eligible for inclusion in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: panniculectomy
surgical intervention
Procedure: panniculectomy
surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in lab values, pulmonary function and quality of life
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Investigators

  • Principal Investigator: James T Thompson, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

November 2, 2011

First Posted (ESTIMATE)

November 3, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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