Post-Op Quality of Life After Colorectal Surgery

Sponsor

University Hospitals Cleveland Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00468455

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Colitis, Ulcerative Diverticulitis Colonic Polyps Crohn Disease	Procedure: Laparoscopic or open colorectal 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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Apr 1, 2008

Actual Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

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 month to 1 hour prior to surgery]
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. [2 weeks 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. [4 weeks 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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