Post-Op Quality of Life After Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00468455
First received: May 1, 2007
Last updated: October 14, 2010
Last verified: October 2010

May 1, 2007
October 14, 2010
October 2005
April 2008   (final data collection date for primary outcome measure)
  • 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. [ Time Frame: 1 month to 1 hour prior to surgery ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 weeks post operatively ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 weeks post operatively ] [ Designated as safety issue: No ]
    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. [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    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.
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Complete list of historical versions of study NCT00468455 on ClinicalTrials.gov Archive Site
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Post-Op Quality of Life After Colorectal Surgery
Postoperative Quality of Life: Development and Assessment of a Novel Tool to Assess Quality of Life Following Colorectal Surgery

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

  • Colorectal Neoplasms
  • Colitis, Ulcerative
  • Diverticulitis
  • Colonic Polyps
  • Crohn Disease
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00468455
10-05-17
No
Conor Delaney, MD, PhD, University Hospitals of Cleveland
University Hospitals of Cleveland
Not Provided
Principal Investigator: Conor Delaney, MD, PhD University Hospitals of Cleveland/ Institute for Surgical Innovation
University Hospitals of Cleveland
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP