Trial · NCT07888140
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Textbook Outcome (TO) Rate | Within 30 days after surgery | The proportion of participants achieving a textbook outcome within 30 days after surgery. Textbook outcome is defined as the composite achievement of all of the following: R0 resection; retrieval of at least 20 lymph nodes; no intraoperative complications; no Clavien-Dindo grade III or higher complications; no ICU/MCU readmission; no surgery-related readmission within 30 days after discharge; no anastomotic leakage of any ECCG grade; length of hospital stay less than 14 days; and no in-hospital death. |
| Secondary | Surgical Preparation Time | During surgery | Time from the initiation of anesthesia to the time when the primary surgeon is able to begin the surgical procedure. |
| Secondary | Operative Time | During surgery | Time from the start of the surgical procedure by the primary surgeon to completion of skin closure. |
| Secondary | Total Operative Time | During surgery | Time from the patient's entry into the operating room to completion of skin closure. |
| Secondary | Intraoperative Blood Loss | During surgery | Total estimated blood loss from the start of surgery to completion of wound closure, measured by visual estimation, suction volume, or weighing of blood-soaked materials. |
| Secondary | Intraoperative Blood Transfusion Rate | During surgery | Proportion of participants who receive a blood transfusion during surgery. |
| Secondary | Postoperative Pain Score | At 24 hours after surgery and before hospital discharge | Pain will be assessed using the modified Wong-Baker Faces Pain Rating Scale. |
| Secondary | Conversion Rate | During surgery | Proportion of participants requiring unplanned conversion of the assigned minimally invasive surgical approach to another surgical approach during the procedure. In the robot-assisted group, conversion to conventional thoracoscopic or open surgery will be recorded; in the conventional minimally invasive surgery group, conversion to open surgery will be recorded. |
| Secondary | Postoperative Length of Hospital Stay | Perioperative | Length of hospital stay following surgery, calculated as the number of days from hospital admission to hospital discharge. |
| Secondary | EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) | Baseline and at 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery | Quality of life will be assessed using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30). |
| Secondary | EORTC Quality of Life Questionnaire-Oesophageal Cancer Module (QLQ-OES18) | Baseline and at 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery | Quality of life will be assessed using the EORTC Quality of Life Questionnaire-Oesophageal Cancer Module (QLQ-OES18). |
| Secondary | Tumor Recurrence Rate | Up to 3 years after surgery | Proportion of participants with local recurrence or distant metastasis during the postoperative follow-up period. |
| Secondary | Overall Survival | Up to 3 years after surgery | Overall survival is defined as the proportion of participants who are alive during the postoperative follow-up period, regardless of postoperative complications or disease recurrence. |
| Secondary | Disease-Free Survival | Up to 3 years after surgery | Disease-free survival is defined as the time from the date of surgery to the first occurrence of disease recurrence, distant metastasis, or death from any cause. |
| Other | Perioperative Major Complication Rate | Up to 30 days after surgery | Proportion of participants experiencing perioperative complications of Clavien-Dindo grade III or higher. |
| Other | Postoperative Readmission Rate | Up to 3 years after surgery | Proportion of participants requiring hospital readmission due to complications related to the primary disease, disease recurrence, or adverse events. |
| Other | Incremental Cost-Effectiveness Ratio (ICER) | At 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery | The incremental economic cost per additional unit of clinical effectiveness of robot-assisted minimally invasive esophagectomy compared with conventional minimally invasive esophagectomy. Effectiveness measures include textbook outcome, conversion rate, length of hospital stay, and tumor recurrence rate. |
| Other | Incremental Cost-Utility Ratio (ICUR) | At 30 days, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery | The incremental economic cost per additional quality-adjusted life-year (QALY) gained with robot-assisted minimally invasive esophagectomy compared with conventional minimally invasive esophagectomy. Health utility will be derived from EQ-5D-5L assessments. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07888140/registered