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Whether the using of uterine manipullator in laparoscopic hysteromyomectomy increases infection rate: a randomized, single-blinding, parallel controlled trial

Whether the using of uterine manipullator in laparoscopic hysteromyomectomy increases infection rate: a randomized, single-blinding, parallel controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008018
Enrollment
Unknown
Registered
2016-02-29
Start date
2016-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Myoma of Uterus

Interventions

intervening group:uterine manipulator
control group:without manipulator

Sponsors

International Peace Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Subjects must meet every criteria blew before included: 1. Researchers must get the informed consent of every patient before specified research procedure; 2. The Chinese subjects must be with sexual life history; 3. The patients suspected hysteromyoma with surgical indications prepare to be treated with hysteromyomectomy; 4. Leucorrhea routine examination is normal; 5. The operation is laparoscopic surgery.

Exclusion criteria

Exclusion criteria: Subjects should be excluded when meet every criteria blew: 1. The patient known to be with infection(including every system); 2. The patient who has underwent uterine operations(including diagnostic curettage ,cervical LEEP treatment, hysteroscopy )in 7 days before the hysteromyomectomy; 3. The operation breaks into uterine cavity in the process of hysteromyomectomy; 4. The patient who has used antibiotics in 7 days before the operation.

Design outcomes

Primary

MeasureTime frame
Infection rate;

Secondary

MeasureTime frame
postoperative disease rate;hemorrhage;hospitalisation period;cost-effectiveness;

Countries

China

Contacts

Public ContactRuihong Xue
wfmcxrh@163.com+86 18221719667

Outcome results

None listed

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