Trial · NCT07898293
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Flatus After Surgery | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to the patient's first self-reported passage of flatus. Patients and their families are instructed to record the exact time (to the nearest minute) immediately upon first flatus using a postoperative recovery diary card. Bedside nurses verify and collect the diary cards three times daily during rounds. Bowel movements induced by glycerin suppository or enema are excluded. |
| Secondary | Area Under the Curve of Movement-Evoked Pain NRS Scores Over 0-72 Hours | 0 to 72 hours postoperatively | Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for movement-evoked pain (MEP) from 0 to 72 hours postoperatively. The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst possible pain. Higher scores mean a worse outcome. Pain is assessed immediately after coughing using standardized instructions ("Please hold your wound with one hand, take a deep breath, and cough forcefully") at 6, 12, 24, 48, and 72 hours after surgery by a blinded assessor. If the patient cannot perform a standard cough, pain during turning in bed is assessed as an alternative, with the reason recorded in the CRF. AUC is calculated using the trapezoidal rule. Pain during turning and ambulation are recorded simultaneously as exploratory analyses. |
| Secondary | Total Rescue Analgesic Consumption in Morphine Equivalent Dose | From PACU admission (T0) until PCIA discontinuation (expected up to 72 hours postoperatively) | Total dose of all rescue analgesic medications administered for breakthrough pain (NRS ≥ 4) from PACU admission (T0) until discontinuation of PCIA and transition to oral analgesia, converted to morphine equivalent dose (mg MEDD) according to standard conversion factors: IV morphine 1 mg = 1 mg MEDD; IV hydromorphone 0.2 mg = 1 mg MEDD; IV tramadol 10 mg = 1 mg MEDD; oral oxycodone 1 mg = 1.5 mg MEDD. The date, time, and dose of each administration are captured concurrently from nursing medication records and the CRF. |
| Secondary | Time to First Bowel Movement | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to the first bowel movement, excluding those induced by glycerin suppository or enema. |
| Secondary | Time to First Tolerance of Liquid Diet | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to first tolerance of a liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion. |
| Secondary | Time to First Tolerance of Semi-Liquid Diet | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to first tolerance of a semi-liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion. |
| Secondary | Time to First Tolerance of Solid Diet | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to first tolerance of a solid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion. |
| Secondary | Area Under the Curve of Resting Pain NRS Scores Over 0-72 Hours | 0 to 72 hours postoperatively | Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for resting pain from 0 to 72 hours postoperatively. The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst possible pain. Higher scores mean a worse outcome. Assessed by a blinded assessor at 6, 12, 24, 48, and 72 hours after surgery. AUC is calculated using the trapezoidal rule. |
| Secondary | Time to First PCIA Pump Press | Measured from the end of surgery up to 48 hours postoperatively | Time from the end of surgery to the patient's first postoperative patient-controlled intravenous analgesia (PCIA) pump activation. |
| Secondary | Total Number of PCIA Pump Presses Within 48 Hours Postoperatively | 0 to 48 hours postoperatively | Total number of patient-controlled intravenous analgesia (PCIA) pump presses (both effective and ineffective attempts) within the first 48 hours after surgery. |
| Secondary | Time to First Independent Ambulation of ≥5 Meters | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to the patient's first independent ambulation of at least 5 meters. |
| Secondary | Postoperative Hospital Stay | From the end of surgery to hospital discharge (expected up to 7 days postoperatively) | Duration of postoperative hospital stay (hours), defined as meeting the uniform discharge criteria: tolerance of oral analgesia, tolerance of a semi-liquid diet, passage of flatus, and absence of uncontrolled complications. |
| Secondary | Incidence and Severity of Postoperative Nausea | 0 to 72 hours postoperatively | Incidence of postoperative nausea. Severity is assessed using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 = no nausea and 10 = most severe nausea. Higher scores mean a worse outcome. |
| Secondary | Incidence and Number of Episodes of Postoperative Vomiting | 0 to 72 hours postoperatively | Incidence and number of episodes of postoperative vomiting. |
| Secondary | Rate of Rescue Antiemetic Use | 0 to 72 hours postoperatively | Rate of postoperative rescue antiemetic administration. |
| Secondary | Incidence and Severity of Abdominal Distension | 0 to 72 hours postoperatively | Incidence of postoperative abdominal distension. Severity is assessed using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 = no distension and 10 = most severe distension. Higher scores mean a worse outcome. |
| Secondary | Incidence of Postoperative Complications | From the end of surgery up to 30 days post-discharge | Incidence of postoperative complications, graded by the Clavien-Dindo classification. |
| Secondary | 30-Day Readmission Rate | 30 days after discharge | Rate of hospital readmission within 30 days after discharge. |
| Secondary | Quality of Life - EORTC QLQ-C30 | Preoperatively, on postoperative day 4, and at 30 days after surgery | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a 0 to 100 scale. For symptom scales, higher scores indicate worse symptoms. For functional scales, higher scores indicate better function. |
| Secondary | Quality of Life - EORTC QLQ-STO22 | Preoperatively, on postoperative day 4, and at 30 days after surgery | Gastric cancer-specific quality of life assessed using the EORTC Quality of Life Questionnaire - Stomach Cancer Module (EORTC QLQ-STO22). Scores range from 0 to 100. Higher scores indicate worse symptoms. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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