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To evaluate the safety and efficacy of clinical application of 3D laparoscopy and 3D endoscopic camera system in prospective, multi-center, randomized, single-blind and parallel controlled trial

To evaluate the safety and efficacy of clinical application of 3D laparoscopy and 3D endoscopic camera system in prospective, multi-center, randomized, single-blind and parallel controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017390
Enrollment
Unknown
Registered
2018-07-27
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

surgery

Interventions

domestic 3D laparoscopy group:use domestic 3D laparoscopy and endoscopic camera system
control group:use the 3D laparoscopy and endoscopic camera system of Karl Storz

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-75 years male or female; 2) Patients who need 3D laparoscopy and endoscopic camera system for diagnosis and surgical treatment.(Patients with gastric stromal tumor and gastric cancer who still have good physical condition, that is, the ECOG physical condition score is no more than 2; Patients with colon cancer, the ECOG physical condition score is no more than 2; Patients with appendicitis; Patients with cholecystitis, gallbladder stones, etc); 3) Voluntary participation and signing of informed consent.

Exclusion criteria

Exclusion criteria: 1) Severe cardiovascular and cerebrovascular diseases with NYHA level III-IV or pulmonary insufficiency, unable to tolerate the surgery; 2) Systemic bleeding tendency and coagulation disorders; 3) Diabetes (random blood glucose >11.1mmol/L) and hypertension (BP >160/100mmHg); 4) Women in pregnancy and lactation; 5) Mental illness, lack of self-control, inability to express clearly; 6) Other contraindications of 3D laparoscopic surgery; 7) Participated in other clinical trials within 3 months; 8) Considered to be unsuitable for the group by researchers.

Design outcomes

Primary

MeasureTime frame
good rate of image quality;Safety evaluation indicators;

Secondary

MeasureTime frame
observation item of 3D laparoscopy;observation item of 3D endoscopic camera system;operation time;

Countries

China

Contacts

Public ContactShaihong Zhu

The Third Xiangya Hospital of Central South University

shaihongzhu@126.com+86 15802537999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026