ROBOT trial: Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy vs. open transthoracic esophagectomy

ROBOT trial: Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy vs. open transthoracic esophagectomy - ROBOT trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41398

Enrollment

112

Registered

2011-11-04

Start date

2012-02-06

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesofagus carcinoom esophageal cancer esophageal carcinoma

Interventions

112patients will be randomly allocated to either A) robot-assisted thoraco-laparoscopic esophagectomy (n=56) or B) open transthoracic esophagectomy (n=56). Patients will receive the following interv

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus. - Surgical resectable (T1-4a, N0-3, M0) - Age * 18 and * 80 years - European Clinical Oncology Group (ECOG) performance status 0,1 or 2 - Written informed consent

Exclusion criteria

Exclusion criteria: - Carcinoma of the cervical and Siewert III gastro-esophageal junction carinoma (GEJ) - Prior thoracic surgery

Design outcomes

Primary

Measure	Time frame
Primary endpoint Overall morbidity: the percentage of overall complications as staded by the modified Clavien-Dindo classification grade 2 t/m 5.	—

Secondary

Measure	Time frame
Secondary endpoints: Individual components of the primary endpoint. Oncologic outcomes: disease free survival (recurrence) and overall survival 1, 2, 3 and 5 years after surgery. Major complications Including: myocardial infarction, anastomotic leakage, chylothorax (chylous leakage, presence of chylous in thoraxdrains or indication start Vivonex®, gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis, vocal cord palsy, pneumonia, atelectasis. Minor complications Including: wound infections, pleural effusions, delayed gastric emptying Operation related events: Operation time is defined as time from incision until closure (minutes) for each phase of surgery. For the robotic procedure, set up time will de recorded seperatley. Unexpected events and complications occurring during the operation will be recorded (e.g. massive hemorrhage, perforation of other organs). Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has to be explained (absolute numbers/percentage). Postoperative recovery: Pain: Type and dose of used analgesics will be noted during the hospital admission period. Visual Analogue Scale (VAS) will be noted at following times: pre-operatively and the first 10 days after surgery. Length of ICU-MCU stay (days) Length of hospital stay (days) Quality of life Questionnaires will be required at following times: SF-36, EORTC QLQ-C30 (Dutch), EORTC OES18 (Dutch) (Appendix 1 & 2) pre-operative	—

Measure

Time frame

Secondary endpoints: Individual components of the primary endpoint. Oncologic outcomes: disease free survival (recurrence) and overall survival 1, 2, 3 and 5 years after surgery. Major complications Including: myocardial infarction, anastomotic leakage, chylothorax (chylous leakage, presence of chylous in thoraxdrains or indication start Vivonex®, gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis, vocal cord palsy, pneumonia, atelectasis. Minor complications Including: wound infections, pleural effusions, delayed gastric emptying Operation related events: Operation time is defined as time from incision until closure (minutes) for each phase of surgery. For the robotic procedure, set up time will de recorded seperatley. Unexpected events and complications occurring during the operation will be recorded (e.g. massive hemorrhage, perforation of other organs). Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has to be explained (absolute numbers/percentage). Postoperative recovery: Pain: Type and dose of used analgesics will be noted during the hospital admission period. Visual Analogue Scale (VAS) will be noted at following times: pre-operatively and the first 10 days after surgery. Length of ICU-MCU stay (days) Length of hospital stay (days) Quality of life Questionnaires will be required at following times: SF-36, EORTC QLQ-C30 (Dutch), EORTC OES18 (Dutch) (Appendix 1 & 2) pre-operative

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)