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
  Purpose

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 Intervention
Colorectal Neoplasms
Colitis, Ulcerative
Diverticulitis
Colonic Polyps
Crohn Disease
Procedure: Laparoscopic or open colorectal surgery

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

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. [ 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.


Enrollment: 100
Study Start Date: October 2005
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468455

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Conor Delaney, MD, PhD University Hospitals of Cleveland/ Institute for Surgical Innovation
  More Information

No publications provided

Responsible Party: Conor Delaney, MD, PhD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00468455     History of Changes
Other Study ID Numbers: 10-05-17
Study First Received: May 1, 2007
Last Updated: October 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Colorectal Surgery
Abdominal Surgery
Diverticulitis
Colon Cancer
Rectal Cancer
Colon Polyp
Rectal Polyp
Crohn's Disease

Additional relevant MeSH terms:
Neoplasms
Colitis
Colitis, Ulcerative
Colonic Polyps
Colorectal Neoplasms
Crohn Disease
Diverticulitis
Polyps
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Intestinal Polyps
Pathological Conditions, Anatomical
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014