Clinical trial · Observational
National Multicenter Cohort Study of Robot-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer
- 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)
In recent years there has been a rapid incursion of robotic technology applied to almost all fields of surgery. In gastric cancer, whose mainstay of treatment is still surgical resection, gastrectomy with robotic lymphadenectomy is growing faster than the scientific evidence supporting its results. The "National Multicenter Cohort Study of ROBOT-Assisted Gastrectomy Versus Laparoscopy in Gastric Cancer" (ROBOTAG study) is proposed as a prospective multicenter Spanish nationwide study, comparing robotic gastrectomy versus conventional laparoscopic gastrectomy for the treatment of gastric cancer. This study aims to provide evidence on the feasibility, safety and complications, possible technical advantages, short and long term surgical and oncological results, as well as aspects related to quality of life, which can support the increase in cost and the important technological effort that underlies robotic surgery with respect to conventional laparoscopic access. The relevance of this project is doubled by directing the objectives, on the one hand, on a new and expensive technology that is reaching hospitals still surrounded by controversy about its real benefits; and on the other hand, by acting on a pathology for which most of the available studies come from Eastern countries, sometimes not very applicable to the Western context.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Gastrectomy | Procedure | — | UNRESOLVED |
| Robot-Assisted Gastrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Robotic Surgery
- description
- Patients underwent gastric surgery through the use of a robotic system.
- interventionNames
- Procedure: Robot-Assisted Gastrectomy
- label
- Laparoscopic Surgery
- description
- Patients underwent gastric surgery with laparoscopic procedures.
- interventionNames
- Procedure: Laparoscopic Gastrectomy
Primary outcomes (2)
- measure
- Compare robotic gastrectomy with the conventional laparoscopic approach in terms of clinical safety.
- timeFrame
- Intraoperative and Postoperative (up to 90 days postoperative)
- description
- Intraoperative blood loss and perioperative complications (types of complications, Clavien Dindo classification, Comprehensive Complication Index (CCI®))
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed primary gastric adenocarcinoma * Clinical stages Ib, II and III of gastric cancer (8th edition of the TNM classification) * Patients with ECOG Performance Status 0, 1 or 2 * Patients who sign the informed consent to participate in the study * Patients over 18 years old * Patients treated by surgery with curative intent * Patients must be suitable for surgery. Exclusion criteria: * Any histology other than adenocarcinoma * Stage Ia and IV * Unresectability criteria (tumor factors): distant metastasis, peritoneal carcinomatosis, positive cytology of ascitic fluid, invasion or tumor entrapment of large vessels (aorta, liver, celiac trunk), infiltration of the root of the mesentery, para-aortic lymphadenopathy or levels \>3, linitis plastica, involvement of other organs * Inoperability criteria (patient factors): serious concomitant systemic disorders incompatible with surgery or the study (at the discretion of the investigator) * Patients undergoing surgery for gastric cancer with open approach at the beginning * Palliative surgery cases * Non-compliance with any of the inclusion criteria
References
Publications (0)
Data not yet available