The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis

Study Overview
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Brief Summary
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The purpose of this study is to understand the patient experience with an adverse event after surgery. An adverse event is an undesirable experience or complication associated with your surgery.

Official Title
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The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: qualitative interviews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Patients who had elective surgery for a primary colorectal cancer within the last 90 days. Patients who either: Develop an eligible complication (Appendix 1) within 30 days of surgery (n = 25 - 30) Do not develop any complication after surgery (n = 25 - 30) Exclusion Criteria: Multivisceral resections Metastatic or locally-recurrent disease Physical impairment that may prevent participation in an interview or survey setting Active psychiatric illness, cognitive or sensory impairment Inability to speak or understand English Refusal to participate in an audio-recorded interview Inability to participate in an audio-recorded interview for reasons not otherwise specified Any second surgical procedure unrelated to the complication within the 90-day period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with complications<br>Each subject will participate in an audio-recorded interview, either in-person or by telephone, expected to last 30 to 60 minutes. Subjects' responses to the interview questions and basic demographic data will remain confidential. The interview will examine the impact of complications utilizing a semi-structured script specific to each group | Behavioral: qualitative interviews<br> <br> |
| patients without Complications (control group)<br>Each subject will participate in an audio-recorded interview, either in-person or by telephone, expected to last 30 to 60 minutes. Subjects' responses to the interview questions and basic demographic data will remain confidential. | Behavioral: qualitative interviews<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications | Information gathered from these interviews will form the basis for the conceptual model of surgical complications. Qualitative data will be obtained from patients who have directly experienced a surgical complication. These complications are defined and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | within 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complications, surgery