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L'essai clinique NCT07138859 pour Carcinome colorectal (CCR), Right Hemicolectomy est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy 368 Immunothérapie Thérapie ciblée Randomisé Grossesse
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L'essai clinique NCT07138859 est une étude interventionnel pour Carcinome colorectal (CCR), Right Hemicolectomy. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 août 2025, avec un objectif de 368 participants. Dirigée par The Affiliated Hospital of Qingdao University, l'étude devrait être terminée d'ici le 1 décembre 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 24 août 2025.
Résumé succinct
Experimental design: This study is a multicenter, prospective, randomized, controlled phase III clinical trial that identifies, classifies, defines, and quantitatively analyzes technical errors between robotic and laparoscopic radical right hemicolectomy (D3 lymph node dissection), identifies surgical risk areas, compares intraoperative performance, and patient short-term and long-term clinical outcomes.
This experi...
Afficher plusDescription détaillée
Right hemicolectomy and lymph node dissection scope: According to the Japanese Society for Colorectal Cancer Research (JSCCR) colon cancer treatment guidelines and the Chinese Society of Clinical Oncology (CSCO) colon cancer diagnosis and treatment guidelines, total mesorectal resection and D3 lymph node dissection are performed.
There are no requirements for digestive reconstruction methods, energy equipment, vascu...
Afficher plusTitre officiel
Prospective, Multiceter, Randomized, Controlled Study on the Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy (Superiority Design，ROBOGEON® 2501study)
Pathologies
Carcinome colorectal (CCR)Right HemicolectomyPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- ROBOGEON 2501 study
Numéro NCT
Date de début (réel)
2025-08
Dernière mise à jour publiée
2025-08-24
Date de fin (estimée)
2030-12
Inscription (estimée)
368
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Colorectal Carcinoma (CRC)
right hemicolectomy
Robotic surgery
Errors
Intraoperative bleeding
Dangerous areas
Clinical outcome
right hemicolectomy
Robotic surgery
Errors
Intraoperative bleeding
Dangerous areas
Clinical outcome
Objectif principal
Autre
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalRobot right hemicolectomy group Perform robot assisted radical right hemicolectomy (D3 lymph node dissection) | Robot assisted radical right hemicolectomy (D3 lymph node dissection) RRH (Robotic Right Hemicolectomy) group: Experimental group: Performing robotic radical right hemicolectomy (D3 lymph node dissection) |
Comparateur actifLaparoscopic right hemicolectomy group Performing traditional laparoscopic radical right hemicolectomy (D3 lymph node dissection) | Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection) LRH (Laparoscopic Right Hemicolectomy) group: control group: underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection) |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Total number of technical errors during right hemicolectomy | Perioperative |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Incidence of intraoperative complications | Perioperative | |
Postoperative hospitalization time | Perioperative | |
Incidence of complications within 30 days after surgery | Within 30 days after surgery | |
3-year disease-free survival rate DFS | Within 3 years after surgery | |
Surgical time | Perioperative | |
estimated blood loss | Perioperative | |
conversion rate to open surgery | Perioperative | |
Early postoperative recovery process (time of first exhaust and defecation) | Perioperative | |
Postoperative nutritional status, inflammation, and immune response | Perioperative | |
Total number of lymph nodes cleared, positive rate of lymph nodes | Perioperative | |
readmission rate within 30 days after surgery | Within 30 days after surgery | |
unplanned reoperation rate within 30 days after surgery | Within 30 days after surgery | |
3-year overall survival rate OS | Within 3 years after surgery |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 18 years old<age<80 years old, regardless of gender;
- The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology;
- The preoperative clinical staging was cStage I-III (cT1-4a, N0/+, M0) (according to UICC/AJCC-8thTNM tumor staging);
- The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers);
- Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs;
- Preoperative ECOG physical status score ≤ 2;
- Preoperative ASA scores I-III;
- Patient informed consent.
- History of colon surgery (excluding ESD/EMR for colon cancer);
- History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy);
- Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;
- Pregnant or lactating women;
- Suffering from severe mental illness;
- Multiple primary cancers;
- History of other malignant diseases within 5 years;
- Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented;
- History of unstable angina or myocardial infarction within 6 months;
- Heart, lung, liver, kidney dysfunction or history of cerebral infarction;
- Simultaneous surgical treatment is required for other diseases;
- Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.
The Affiliated Hospital of Qingdao UniversityPartie responsable de l'étude
Zhou Yanbing, Investigateur principal, Professor, The Affiliated Hospital of Qingdao University
Contact central de l'étude
Contact: Kun Wang, +86 15621138120, [email protected]
1 Centres de l'étude dans 1 pays
Province
The Affiliated Hospital of Qingdao University, Shandong, Province, 266071, China