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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00468455
Enrollment
100
Registered
2007-05-02
Start date
2005-10-31
Completion date
2008-05-31
Last updated
2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDURELaparoscopic 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.

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.1 month to 1 hour prior to surgeryThe 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 patients1 year post-operativelyThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026