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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01464658
Recruitment Status : Terminated (Due to complexity and cost of study (no outside funding))
First Posted : November 3, 2011
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:

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 or disease Intervention/treatment Phase
Panniculitis Procedure: panniculectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients
Study Start Date : March 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
surgical intervention
Procedure: panniculectomy

Primary Outcome Measures :
  1. Improvement in lab values, pulmonary function and quality of life [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01464658

Sponsors and Collaborators
Wake Forest University
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Principal Investigator: James T Thompson, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Identifier: NCT01464658    
Other Study ID Numbers: IRB00008184
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Additional relevant MeSH terms:
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Connective Tissue Diseases
Skin Diseases