A prospective, multicenter clinical study to evaluate the safety profile of the FlexiSurge Adhesion Barrier for the prevention of intra-abdominal adhesion formation after laparotomy

A prospective, multicenter clinical study to evaluate the safety profile of the FlexiSurge Adhesion Barrier for the prevention of intra-abdominal adhesion formation after laparotomy - FlexiSurge Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40303

Enrollment

Registered

2014-02-24

Start date

2014-06-20

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

vorming van adhesies na buikchirurgie adhesion formation postoperative adhesions

Interventions

All patients will receive the standard of care before and after laparotomy. In addition, the patients will receive the FlexiSurge medical device as anti-adhesion barrier.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: elective colectomy elective colectomy with temporary stoma placement, followed by elective stoma reversal elective liver first surgery, followed by elective surgical colectomy ASA score 1-3

Exclusion criteria

Exclusion criteria: previous surgery through abdominal incision patients with a known history of adhesiolysis BMI =35

Design outcomes

Primary

Measure	Time frame
Evaluation of Adverse Events reported during the study	—

Secondary

Measure	Time frame
Time to discharge; post discharge follow up; implant handling and macroscopical features of the FlexiSurge Adhesion Barrier; Incidence, severity and extent of the adhesions formed	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)