Bovine Reinforcement in Stomach, Colorectal and Lung Operation

ConditionsRectal Cancer Stage III Lung Cancer Stage III

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai Cingularbio Co. Ltd

About this trial

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement

Subjects willing to accept informed consent and willing to attend the follow up

Disqualifiers

Subjects who have significant intraoperative hypotension or cardiac events.

Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values).

Subjects have uncontrolled intra-abdominal infection

Trial design

Design model

Parallel

Treatments tested in this trial

Bioabsorbable Staple Line Reinforcemen
Device
cingular Bioabsorbable Staple Line Reinforcement

Treatment groups

172 Participants

are divided into 2 treatment groups

Group A: Bioabsorbable Staple Line Reinforcement configured for circular staplersExperimental treatment 1 intervention

Group B: anastomotic staple line without reinforcementActive comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of Subjects Who Experience a hemorrage

The primary endpoint for the study is the proportion of subjects who experience a hemorrage through 10 min post procedure.

Time frame

10 min

Secondary outcomes

Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak

The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 1-3 months post procedure.

Time frame

1-3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Cingularbio Co. Ltd

Lead sponsor

RenJi Hospital

Collaborator

Source ClinicalTrials.gov

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