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Evaluation of efficacy and safety of an ultrasonic surgical system and reusable shear for ultrasonic surgical system in colorectal surgery: A prospective, single-center, randomized, open, parallel controlled, non-inferiority trial

Evaluation of efficacy and safety of an ultrasonic surgical system and reusable shear for ultrasonic surgical system in colorectal surgery: A prospective, single-center, randomized, open, parallel controlled, non-inferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056450
Enrollment
Unknown
Registered
2022-02-06
Start date
2022-02-11
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

colorectal cancer

Interventions

Experiment Group A:Use the ultrasonic surgical systems (Ezisurg Medical Co., Ltd.) in the colorectal surgery
Experiment Group B:Use the reusable shear for ultrasonic surgical system (Ezisurg Medical Co., Ltd.) in the colorectal surgery
Control Group:Use the Harmonic Ace+7, 5mm Diameter Shears with Advanced Hemostasis (Ethicon Endo-Surgery,LLC) in the colorectal surgery

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients volunteer to participate in the experiment and sign the informed consent; 2. Aged 18 to 75 years, no gender limited; 3. Require ultrasonic surgical system in open or endoscopic colorectal surgery; 4. Can communicate well with researchers and comply with study requirements.

Exclusion criteria

Exclusion criteria: 1. Have serious diseases in heart, liver, lung, kidney, brain or hematological system, serious metabolic diseases or cannot bear surgery; 2. Need to undergo surgery of bone, or central nervous system; 3. Need to undergo contraceptive tubal ligation; 4. Women who are pregnant or breast-feeding, or expect to become pregnant within 6 months; 5. With mental disorders; 6. Have a history of allergy to multiple drugs or have allergic diseases recently; 7. Participate in other clinical trials within 3 months; 8. The investigators consider inappropriate to participate because of other reasons.

Design outcomes

Primary

MeasureTime frame
Overall good performance rate;

Secondary

MeasureTime frame
Procedure time;Intraoperative blood loss;Eschar and tissue stick;Thermal damage;Burnt smell and smoke;Length of hospital stay;Drainage condition;Operational performance satisfaction;

Countries

China

Contacts

Public ContactXu Ye

Fudan University, Shanghai Cancer Center

yexu@shmu.edu.cn+86 21 64175590

Outcome results

None listed

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