Post-Op Quality of Life After Colorectal Surgery - Full Text View

Sponsored by:	University Hospitals of Cleveland
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00468455

Purpose

The purpose of this study is to produce a user-friendly tool- in the form of a questionnaire - to accurately assess early quality of life in patients after abdominal colorectal surgery from the first day after surgery to 6 months after. The study will also compare this questionnaire to the other currently available assessment tools. Patients are invited to participate if they are undergoing abdominal colorectal surgery at University Hospitals of Cleveland.

Condition	Intervention
Colorectal Neoplasms Colitis, Ulcerative Diverticulitis Colonic Polyps Crohn Disease	Procedure: Laparoscopic or open colorectal surgery

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Cancer Colonic Polyps Colorectal Cancer Crohn's Disease Diverticulosis and Diverticulitis Surgery Ulcerative Colitis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Postoperative Quality of Life: Development and Assessment of a Novel Tool to Assess Quality of Life Following Colorectal Surgery

Further study details as provided by University Hospitals of Cleveland:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	October 2005
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Application of a post-operative diary to be completed by subjects. The intervention is standard of care laparoscopic or open surgery.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients scheduled to undergo laparscopic or open procedures from the Deopartment of Surgery at University Hospitals of Cleveland.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468455

Locations

United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals of Cleveland

Investigators

Principal Investigator:

Conor Delaney, MD, PhD

University Hospitals of Cleveland/ Institute for Surgical Innovation

More Information

No publications provided

Responsible Party:	University Hospitals of Cleveland ( Conor Delaney, MD, PhD )
Study ID Numbers:	10-05-17
Study First Received:	May 1, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00468455 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Colorectal Surgery
Abdominal Surgery
Diverticulitis
Colon Cancer

Rectal Cancer
Colon Polyp
Rectal Polyp
Crohn's Disease

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Crohn's Disease
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases
Inflammatory Bowel Diseases
Quality of Life
Polyps
Rectal Diseases
Ileal Diseases
Diverticulitis
Digestive System Neoplasms
Ileitis
Ulcer

Enteritis
Rectal Neoplasm
Colonic Polyps
Colitis, Ulcerative
Intestinal Diseases
Intestinal Neoplasms
Digestive System Diseases
Rectal Cancer
Crohn Disease
Gastrointestinal Neoplasms
Gastroenteritis
Colitis
Colorectal Neoplasms

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gastrointestinal Diseases
Colonic Diseases
Inflammatory Bowel Diseases
Polyps
Rectal Diseases
Ileal Diseases
Diverticulitis
Neoplasms by Site
Pathologic Processes
Digestive System Neoplasms
Ileitis
Enteritis

Colonic Polyps
Colitis, Ulcerative
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Digestive System Diseases
Intestinal Polyps
Crohn Disease
Gastrointestinal Neoplasms
Gastroenteritis
Colitis
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009