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A randomized controlled study on the efficacy and safety of tubal ligation via the anterior and posterior fornix approach in transvaginal natural orifice transluminal endoscopic surgery

A randomized controlled study on the efficacy and safety of tubal ligation via the anterior and posterior fornix approach in transvaginal natural orifice transluminal endoscopic surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035732
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

diseases of obstetrics and gynecology

Interventions

Group A:posterior fornix approach for transvaginal natural orifice transluminal endoscopic surgery
Group B:anteriorr fornix approach for transvaginal natural orifice transluminal endoscopic surger

Sponsors

Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 years; 2) Married women who voluntarily request tubal ligation and sterilization; or those who are not suitable for pregnancy due to certain diseases such as heart disease, kidney disease, severe genetic disease, etc.; or those who require tubal ligation due to the failure of assisted reproduction due to hydrosalpinx; 3) The patients were able to understand the protocol and were willing to participate in the study. Written consent was provided.

Exclusion criteria

Exclusion criteria: 1) Pelvic adhesion is serious and transvaginal operation is difficult; 2) Acute infection stage or Body temperature >= 37.5 degrees C twice in 24 hours;; 3) Asexual life history or pregnancy; 4) Patients with severe underlying diseases and unable to tolerate surgery and anesthesia; 5) Participated in other clinical trials within 3 months before participating in this clinical trial; 6) The presence of mental illness or drug abuse that may affect compliance with the trial requirements is known; 7) Other investigators considered it unsuitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Perioperative complications;

Secondary

MeasureTime frame
The amount of bleeding during the operation;;Operation time;Postoperative pain score;The time of exhaust, urination and defecation was recovered after operation;Incidence of postoperative nausea and vomiting;Hospitalization days;Patient satisfaction;Hospitalization expenses;Sexual life;

Countries

China

Contacts

Public ContactYonghong Lin

Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China

linyh.2007@aliyun.com+86 13808031895

Outcome results

None listed

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