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Postoperative Quality of Life: Development and Assessment of a Novel Tool to Assess Quality of Life Following Colorectal Surgery


N/A
18 Years
85 Years
Not Enrolling
Both
Colorectal Neoplasms, Colitis, Ulcerative, Diverticulitis, Colonic Polyps, Crohn Disease

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Trial Information

Postoperative Quality of Life: Development and Assessment of a Novel Tool to Assess Quality of Life Following Colorectal Surgery


The purpose of this study is to produce a user-friendly tool to accurately assess early
quality of life in postoperative patients following abdominal colorectal surgery in the
early postoperative period (from surgery to 6 months) that is practical for routine
application. The study will also compare this tool to the current available tools, namely
the Short Form (SF-36), the short form inflammatory bowel disease questionnaire (IBDQ), the
Cleveland Clinic Global Quality of Life (CGQOL). Patients will be invited to participate if
they are undergoing abdominal colorectal surgery at University Hospitals of Cleveland.


Inclusion Criteria:



- Subjects who are 18 years of age and older

- Subjects of either sex

- Subjects who will undergo any colorectal abdominal surgery at University Hospitals of
Cleveland

- Subjects who agree to participate in the study program and provide written informed
consent

- Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or
rectal polyps and diverticulitis

Exclusion Criteria:

- Patients in the middle of three part surgery or had recent surgery (i.e., back for
stoma closure for J-pouch)

- Patients with diagnosis of rectal prolapse, condyloma or any other condition that
cannot be performed abdominally with an open or laparoscopic procedure

- Patient who have undergone major surgery within the month prior to this colorectal
surgery

- Pregnant women, minors, psychiatric patients and prisoners

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients.

Outcome Description:

The aim of this study is to evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients. We would like to use this survey to elucidate how quality of life of the patient is changed with the presence of an abdominal wall hernia.

Outcome Time Frame:

1 month to 1 hour prior to surgery

Safety Issue:

No

Principal Investigator

Conor Delaney, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals of Cleveland/ Institute for Surgical Innovation

Authority:

United States: Institutional Review Board

Study ID:

10-05-17

NCT ID:

NCT00468455

Start Date:

October 2005

Completion Date:

May 2008

Related Keywords:

  • Colorectal Neoplasms
  • Colitis, Ulcerative
  • Diverticulitis
  • Colonic Polyps
  • Crohn Disease
  • Colorectal Surgery
  • Abdominal Surgery
  • Diverticulitis
  • Colon Cancer
  • Rectal Cancer
  • Colon Polyp
  • Rectal Polyp
  • Crohn's Disease
  • Neoplasms
  • Colitis
  • Colitis, Ulcerative
  • Colonic Polyps
  • Colorectal Neoplasms
  • Crohn Disease
  • Diverticulitis
  • Polyps
  • Ulcer

Name

Location

University Hospitals of ClevelandCleveland, Ohio  44106