The Expeditious Transection/resection of Tissues and Creation of Anastomoses
Conditions
Brief summary
This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.
Interventions
DEVICEDisposable endoscopic linear cutter stapler
Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)
Sponsors
Suzhou Kerui Medical Technology Co., Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age unlimited and gender unlimited; * The surgery type shall be endoscopic surgery; * The departments of surgical procedures: general and thoracic surgical procedures; * Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.
Exclusion criteria
* Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen; * Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site; * Surgery record is incomplete, unable to extract main indicators related information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomosis success rate | the investigation sites will be collected from January 2023 to September 2024. | The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of intraoperative blood loss | the investigation sites will be collected from January 2023 to September 2024. | Confirmed by surgical records/nursing notes. |
| Intraoperative conversion (caused by the stapler and/or cartridge) | the investigation sites will be collected from January 2023 to September 2024. | Surgical records confirm the intraoperative conversion, and determine whether the intraoperative conversion is caused by the investigational devices according to the description. |
| Length of hospitalization | the investigation sites will be collected from January 2023 to September 2024. | Records were collected for the patient's date of surgery and date of discharge . Length of hospitalization(days) = date of discharge - date of surgery |
| All-cause re-hospitalization rate (within 6 months) | From the date of surgery to six months after the surgery | Re-hospitalization data of patients within 6 months after surgery were collected. Postoperative all-cause re-hospitalization rate = number of all-cause re-hospitalization cases/total cases ×100% |
| Operation time | The investigation sites will be collected from January 2023 to September 2024. | Confirmed by surgical records and anesthesia sheets. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | From the date of surgery to six months after the surgery | Incidence of serious adverse events = Number of serious adverse events/number of enrolled cases ×100% |
| Device deficiencies | From the date of surgery to six months after the surgery | Inadequacy of medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. |
| Adverse events | From the date of surgery to six months after the surgery | Common adverse events due to the device and treatment were: anastomotic leakage, bleeding, stenosis, fistula, infection, etc. |
Countries
China
Contacts
Primary ContactKe Zhou
Outcome results
None listed