Clinical trial · Observational
The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
NCT02836535CI-TRIAL-00028340completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| qualitative interviews | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients with complications
- description
- 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
- interventionNames
- Behavioral: qualitative interviews
- label
- patients without Complications (control group)
- description
- 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.
- interventionNames
- Behavioral: qualitative interviews
Primary outcomes (1)
- measure
- Number of complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.