Hysteroscopic resection of uterine scar defects (niche) in patients with abnormal bleeding, a randomised controlled trial

Hysteroscopic resection of uterine scar defects (niche) in patients with abnormal bleeding, a randomised controlled trial - HysNiche study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39029

Enrollment

100

Registered

2012-04-04

Start date

2012-07-12

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

CS scar defect Isthmocele

Interventions

The patients allocated for hysteroscopic niche resection will undergo the procedure under spinal or general anaesthesia in lithotomic position. An experienced gynaecologist will asses the niche and

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with post menstrual spotting (more than 2 days or menstruation of at least 10 days) and a large niche(at least 2mm) with a residual myometrium more than 3 mm.

Exclusion criteria

Exclusion criteria: Patients aged below 18 or pregnant. Other causes of postmenstrual spotting ( abnormalities in the uterine cavity) Contraindications for general or spinal anesthesia.

Design outcomes

Primary

Measure	Time frame
Primary: number of days with postmenstrual spotting in the first 6 months after randomization	—

Secondary

Measure	Time frame
Secondary: menstrual pattern (score card) and related pain (VAS) and disturbance (VAS), quality of life (SF36, EuroQol), patient satisfaction, sexual function (FSFI), medical consultation and medication use, complications, sick leave, and costs (diary) after 3, 6 and 12 months after randomization. Characterisitics of the niche (3 months after randomization, size/volume of the niche).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)