Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07486622

Enrollment

Registered

2026-03-20

Start date

2025-03-01

Completion date

2026-03-10

Last updated

2026-03-20

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

Conditions

Adenomyosis, Enlarged Uterus, Uterine Fibroids

Keywords

Uterine Fibroids, Adenomyosis, Enlarged Uterus

Brief summary

This study evaluates the feasibility, safety, and efficiency of transvaginal in-bag electromechanical morcellation for specimen extraction in patients undergoing total laparoscopic hysterectomy for large uteri.

Detailed description

This single-center prospective study investigates a novel transvaginal specimen extraction technique using a sealed containment bag combined with electromechanical morcellation. The procedure aims to improve specimen extraction efficiency while preventing tissue dissemination during laparoscopic hysterectomy for uteri larger than 12-week gestational size.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

38 Years to 52 Years

Healthy volunteers

Inclusion criteria

Female patients aged 38 to 52 years Planned to undergo total laparoscopic hysterectomy Uterine size greater than 12 weeks gestational size based on preoperative imaging Eligible for transvaginal specimen extraction Able and willing to provide written informed consent

Exclusion criteria

Advanced gynecologic malignancy Severe pelvic obliteration preventing transvaginal access Contraindication to laparoscopic surgery Pregnancy Inability or unwillingness to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
Containment bag integrity	Immediately after specimen extraction	Integrity of the specimen containment bag assessed using methylene blue leakage testing following specimen extraction

Secondary

Measure	Time frame	Description
Specimen extraction time	Periprocedurally	Duration required to complete transvaginal in-bag electromechanical morcellation and removal of the uterine specimen, measured in minutes.
Total operative time	Immediately after surgery	Total duration of surgery measured from skin incision to completion of wound closure.
Estimated intraoperative blood loss	During surgery	Estimated blood loss recorded during the surgical procedure.
Postoperative complications	Up to 30 days postoperatively	Incidence of postoperative complications including infection, fever, or organ injury.
Length of postoperative hospital stay	Up to 7 days postoperatively	Number of days from surgery until hospital discharge.

Countries

China

Outcome results