Post-market clinical follow-up of disposable endoscope linear cutting staplers and components

Not Applicable

• Conditions: Gastrointestinal disease

• Registration Number: ChiCTR2400088987
• Lead Sponsor: The First Affiliated Hospital of Zhejiang University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Gender unlimited, age unlimited;<br>2) Open surgery or endoscopic surgery;<br>3) Surgical sites are lung, bronchial tissues, stomach and intestines. For resection, transection and anastomosis of them;<br>4) Use the study device during the operation (disposable endoscopic linear cutter stapler adn its components, single shaft type).

Exclusion Criteria

1. Patients with contra-indications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;<br>2) Combined with other similar products (staplers) for surgical resection, transsection and anastomosis;<br>3) Surgical records are incomplete, and information related to major indicators cannot be extracted;<br>4) Other situations that the researcher considers inappropriate for inclusion in the study.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anastomosis success rate;

Secondary Outcome Measures

Name	Time	Method
Operation duration;Peroperative bleeding;Intraoperative conversion (due to stapler);Duration of hospitalization;All-cause readmission rate (within 6 months);