Post-Op Quality of Life After Colorectal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Neoplasms, Colitis, Ulcerative, Diverticulitis, Colonic Polyps, Crohn Disease

Intervention / Treatment
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* Procedure: Laparoscopic or open colorectal surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic or open colorectal surgery|Application of a post-operative diary to be completed by subjects. The intervention is standard of care laparoscopic or open surgery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 month to 1 hour prior to surgery | 
| 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. | 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. | 2 weeks post operatively | 
| 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. | 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. | 4 weeks post operatively | 
| 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. | 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. | 6 months post-operatively | 
| 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 | 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. | 1 year post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Surgery, Abdominal Surgery, Diverticulitis, Colon Cancer, Rectal Cancer, Colon Polyp, Rectal Polyp, Crohn's Disease