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

This study has been terminated.
(Due to complexity and cost of study (no outside funding))
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01464658
First received: August 9, 2010
Last updated: November 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Panniculitis
Procedure: panniculectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Improvement in lab values, pulmonary function and quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: March 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
panniculectomy
surgical intervention
Procedure: panniculectomy
surgery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464658

Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: James T Thompson, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: James T. Thompson, MD, Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT01464658     History of Changes
Other Study ID Numbers: 8184
Study First Received: August 9, 2010
Last Updated: November 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
panniculitis
panniculectomy

Additional relevant MeSH terms:
Panniculitis
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014