A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)

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Inicieu sessió / registreu-vos

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Patrocinadors

First Affiliated Hospital Xi'an Jiaotong University

ASSAIG CLÍNIC: NCT03804762

BioSeek: nct03804762

Paraules clau

tumor de l estroma gastrointestinal

Resum

The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage of the methodology of the third space, making it possible to dissect gastric GISTs (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid operation.

Dates

Darrera verificació:	03/31/2018
Primer enviat:	12/22/2018
Inscripció estimada enviada:	01/10/2019
Publicat per primera vegada:	01/14/2019
Última actualització enviada:	01/10/2019
Publicació de l'última actualització:	01/14/2019
Data d'inici de l'estudi real:	04/04/2018
Data estimada de finalització primària:	12/14/2018
Data estimada de finalització de l’estudi:	12/19/2018

Condició o malaltia

Gastric Soft Tissue Neoplasm

Intervenció / tractament

Procedure: patients received treatment of TS-RECS

Fase

Grups de braços

Braç	Intervenció / tractament
Experimental: patients received treatment of TS-RECS	Procedure: patients received treatment of TS-RECS This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.

Criteris d'elegibilitat

Edats elegibles per estudiar	18 Years Per a 18 Years
Sexes elegibles per estudiar	All
Accepta voluntaris saludables	Sí
Criteris	Inclusion Criteria: - Patients with gastric GISTs originating from muscularis propria diagnosed by EUS (endoscopic ultrasound)； - The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal cross-sectional diameter of tumor <2cm but with malignant potential ( irregular shape, cystic space, heterogeneity and rapid growth during follow-ups ) ； - No evidence of tumor metastasis on all per-operative evaluations； Exclusion Criteria: - 1. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension; - 2. Patients with advanced malignant tumor; - 3. Patients were required the emergency operation by complete intestinal obstruction, perforation and hemorrhage caused by the tumor; - 4.Patients with ulcer penetration into tumors; - 5. Patients with the contraindications for general anesthesia; - 6. Patients were pregnant or younger than 18 years old；

Resultat

Mesures de resultats primaris

1. the rate of adverse events [through study completion, an average of 6 months]

Adverse events included intraoperative adverse (full-thickness perforation, hemorrhage, injury of visceral organs and vessel, and anaesthesia complications), and postoperative adverse events (infectious complications, intra-abdominal /intraluminal bleeding, gastric stasis and leakage)

Mesures de resultats secundaris

1. rate of en bloc resection [1 day]

the en bloc resection was defined as complete tumor resection with negative surgical margin.

2. the rate of intact mucosal layer [1 day]

intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation

3. operation time [1 day]

Operation time was defined from the time of docking to the time of trocar incision closure.

4. estimated blood loss [1 day]

Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.

5. time to oral diet [30 days]

time to oral diet to assess the postoperative course.

6. duration of postoperative hospital stay [30 days]

From the day of operation to the day of discharged, duration of postoperative hospital stay to assess the postoperative course.