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Gerandomiseerde studie naar de effecten van opereren met LigaSure System op het post-operatief herstel en functioneren van de bekkenbodem na abdominale uterus extirpatie.

A randomized controlled trial comparing the effects of electrosurgical bipolar vessel sealing versus conventional suturing in patients undergoing abdominal hysterectomy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20645
Enrollment
48
Registered
2007-10-25
Start date
2005-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Abdominal hysterectomy for benign disease.

Interventions

1. Conventional surgery using suturing and clamps
2. Vessel sealing using LigaSure.

Sponsors

Jan-Paul W.R. Roovers, MD, PhD Department of Obstetrics and Gynaecology Academic Medical Center Amsterdam Room H4-205 PO Box 22660 1105 DD Amsterdam The Netherlands Phone number: +31-20-5663454 Fax number: +31-20-6963489 E-mail: j.p.roovers@amc.uva.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing abdominal hysterectomy.

Exclusion criteria

Exclusion criteria: 1. Indication for hysterectomy is gynaecologic malignancy; 2. Indication is genital prolapse; 3. Patients undergoing concomitant surgical procedures.

Design outcomes

Primary

MeasureTime frame
Postoperative pain.

Secondary

MeasureTime frame
1. Resuming normal daily activities; 2. postoperative pelvic floor function; 3. complications; 4. blood loss; 5. duration of surgery; 6. duration of hospitalisation.

Contacts

Public ContactJan-Paul W.R. Roovers

PO Box 22660

j.p.roovers@amc.uva.nl+31 (0)20 5666429

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)