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Post-Op Quality of Life After Colorectal Surgery

NCT ID: NCT00468455

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-05-31

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.

Conditions

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Colorectal Neoplasms Colitis, Ulcerative Diverticulitis Colonic Polyps Crohn Disease

Keywords

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Colorectal Surgery Abdominal Surgery Diverticulitis Colon Cancer Rectal Cancer Colon Polyp Rectal Polyp Crohn's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Conor Delaney, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Conor Delaney, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Cleveland/ Institute for Surgical Innovation

Locations

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University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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10-05-17

Identifier Type: -

Identifier Source: org_study_id