Post-Op Quality of Life After Colorectal Surgery

Completed

• Conditions: Colonic Polyps; Crohn Disease; Colorectal Neoplasms; Colitis, Ulcerative; Diverticulitis

• Registration Number: NCT00468455
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-05-01
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-02
• Primary Completion: 2008-04
• Study Completion: 2008-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	1 year post-operatively	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.
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.	6 months post-operatively	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.

Trial Locations

Locations (1)

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States