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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02836535
Enrollment
9
Registered
2016-07-19
Start date
2016-07-31
Completion date
2017-06-28
Last updated
2017-06-29

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

Conditions

Colorectal Cancer

Keywords

complications, surgery

Brief summary

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.

Interventions

BEHAVIORALqualitative interviews

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Number of complicationswithin 90 daysInformation 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.

Countries

United States

Outcome results

None listed

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