Clinical trial NCT01464658: Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients
Official title: Prospective Study of Functional and Quality of Life Outcomes in Panniculectomy Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Panniculitis
Keywords: panniculitis
panniculectomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Improvement in lab values, pulmonary function and quality of life
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: James T Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References: