Clinical trial NCT00468455: Post-Op Quality of Life After Colorectal Surgery
Official title: Postoperative Quality of Life: Development and Assessment of a Novel Tool to Assess Quality of Life Following Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Colitis, Ulcerative
Diverticulitis
Colonic Polyps
Crohn Disease
Keywords: Colorectal Surgery
Abdominal Surgery
Diverticulitis
Colon Cancer
Rectal Cancer
Colon Polyp
Rectal Polyp
Crohn's Disease
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2007-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
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.
timeFrame: 1 month to 1 hour prior to surgery
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.
timeFrame: 2 weeks post operatively
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.
timeFrame: 4 weeks post operatively
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.
timeFrame: 6 months post-operatively
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
timeFrame: 1 year post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals of Cleveland/ Institute for Surgical Innovation
name: Conor Delaney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: