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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836535
• Other study ID #: 16-940
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: June 28, 2017
• Start date: July 2016
• Est. completion date: June 28, 2017

Study information

• Verified date: August 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 28, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• qualitative interviews

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center