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

NCT01464658 | Terminated

• 1 other identifier: IRB00008184
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Panniculitis

Keywords

panniculitis; panniculectomy

Outcome Measures

Primary Outcomes (1)

• Improvement in lab values, pulmonary function and quality of life

  1 year

Study Arms (1)

panniculectomy

OTHER

surgical intervention

Procedure: panniculectomy

Interventions

panniculectomy PROCEDURE

surgery

panniculectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects under the age of 18 or older than 80 years of age

Sponsors & Collaborators

• Wake Forest University: lead

MeSH Terms

Conditions

Panniculitis

Interventions

Abdominoplasty

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• James T Thompson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: November 3, 2011
• Study Start: March 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 15, 2018

Record last verified: 2018-08