This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
LCSS was a randomized crossover study evaluating a warm water intervention among laparoscopic cholecystectomy patients. The registry lists abdominal distention and laparoscopic cholecystectomy as the study conditions.
| Feature | LCSS |
|---|---|
| NCT ID | NCT06154928 |
| Status | Completed |
| Phase | NA |
| Allocation | Randomized |
| Masking | None |
| Primary purpose | Supportive care |
| Intervention | Drinking Warm Water Intervention |
2. Clinical Question
Population
Patients undergoing laparoscopic cholecystectomy.
Intervention
Drinking warm water intervention.
Comparator
The randomized crossover comparator condition.
Primary question
What effects does warm water have on gastrointestinal outcomes in laparoscopic cholecystectomy patients?
3. Trial Design
The registry describes LCSS as a randomized crossover trial with two arms and no masking. A crossover design allows participants to receive more than one intervention condition, allowing within-person comparisons when appropriate.
Design
Randomized crossover study.
Enrollment
100 participants.
Study period
Start date: 2021-01-01.
Primary completion date: 2021-04-01.
Sponsor
İslam Elagöz.
4. Endpoints
| Endpoint | Registry definition |
|---|---|
| Descriptive Information Form | The descriptive information form consisted of two parts. The first part included seven open-ended and five multiple-choice questions to determine descriptive characteristics and was completed by patients 1 day before surgery. The second part included nine multiple-choice questions determining surgical characteristics. |
| Time frame | Up to 18 weeks |
5. Planned Analysis
The ClinicalTrials.gov record does not contain posted results or formal statistical analyses for LCSS. The registry reports measurement of descriptive and surgical characteristics through the Descriptive Information Form.
For a randomized crossover study, statistical analysis commonly focuses on within-participant comparisons while accounting for the paired nature of observations. Depending on the outcome type, analyses may include paired comparisons, crossover-specific models, or regression approaches that account for treatment period and sequence effects.
6. Statistical Methodology
Crossover design analysis
Crossover trials differ from parallel-group trials because participants may contribute information under multiple treatment conditions. The individual participant becomes an important comparison unit, potentially reducing variability from differences between participants.
A crossover design can improve efficiency when treatment effects are temporary and outcomes return toward baseline between periods. However, carryover effects, period effects, and sequence effects must be considered when interpreting crossover results.
Randomization
Randomization reduces systematic differences between assigned sequences. In crossover studies, randomization of treatment order helps balance possible time-related influences.
Missing data considerations
The registry does not report missing data handling or imputation methods. In crossover studies, incomplete participant sequences can affect the available within-person comparisons.
7. Statistical Methods Explained
Why use a crossover design?
A crossover design allows the same participant to experience different study conditions, potentially reducing variability caused by differences between individuals.
Why is randomization still important in crossover trials?
Randomization helps distribute treatment order and timing effects across participants.
What is a period effect?
A period effect occurs when outcomes change over time independent of the intervention itself, such as recovery after surgery.
What is a carryover effect?
A carryover effect occurs when the influence of one intervention condition persists into a later study period.
Why are within-person comparisons useful?
Comparing participants with themselves can reduce variability from stable individual characteristics.
8. Limitations
- No posted results: The ClinicalTrials.gov record does not report trial outcome results or statistical analyses.
- Crossover assumptions: Interpretation depends on assumptions regarding carryover and period effects.
- Masking: The registry reports no masking, which may influence subjective outcome assessment.
- Endpoint detail: The registry lists the descriptive information form as the primary endpoint rather than a quantitative treatment-effect estimate.
9. Why This Trial Matters Statistically
| Concept | How it appears in LCSS |
|---|---|
| Randomization | Randomized allocation |
| Crossover design | Participants may contribute information across intervention conditions |
| Supportive care research | Evaluation of a supportive intervention after surgery |
| Within-person analysis | Important consideration in crossover studies |
| Missing data | Important consideration when crossover sequences are incomplete |
10. Related Tutorials
Learn more about the methods used in this trial: