Effect of Voluven on postoperative morbidity after gynaecological surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004720-37-BE

Enrollment

Registered

2006-09-12

Start date

2006-12-11

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Healthy female patients (American Society of Anaesthesiologists score I or II) programmed for elective gynaecological surgery and at least 18 years old MedDRA version: 8.1 Level: LLT Classification code 10054182 Term: Perioperative nausea and vomiting prophylaxis

Interventions

Trade Name: Voluven Product Name: Voluven Pharmaceutical Form: Intravenous infusion Other descriptive name: CORN STARCH Concentration unit: % percent Concentration type: equal Concentration number: 6-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I or II female patients for elective gynaecological surgery and at least 18 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergic reaction to Voluven Caesarean

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the incidence of postoperative nausea and vomiting after gynaecological surgery;Secondary Objective: To evaluate time before realimentation - incidence of allergic reactions - incidence of prurit - wellness - time of first standing;Primary end point(s): Incidence of nausea and vomiting	—

Countries

Belgium

Outcome results

None listed

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