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

Not Applicable

Completed

• Conditions: Gastric Soft Tissue Neoplasm
• Interventions: Procedure: the third space robotic and endoscopic cooperative surgery

• Registration Number: NCT03804762
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-05
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-20
• Study First Submitted: 2018-12-23
• Study First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients received treatment of TS-RECS	the third space robotic and endoscopic cooperative surgery	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
rate of en bloc resection	1 day	the en bloc resection was defined as complete tumor resection with negative surgical margin.
the rate of intact mucosal layer	1 day	intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation
operation time	1 day	Operation time was defined from the time of docking to the time of trocar incision closure.
estimated blood loss	1 day	Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.
time to oral diet	30 days	time to oral diet to assess the postoperative course.
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.

Trial Locations

Locations (1)

the First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xi'an, Shaanxi, China