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OpenTrials
Completed

NCT Number: NCT02836535

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualitative interviews

Behavioral

Primary outcomes

  1. Number of complications

    Time frame: within 90 days

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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