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NCT Number: NCT07486622

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Uterine Fibroids Adenomyosis Enlarged Uterus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Urogenital Diseases Uterine Diseases

Age range

38 year–52 year

Sex eligibility

Female

Study type

Observational

Primary location

China-Japan Friendship Hospital

Beijing, No. 2, Xinghua East Street, Chaoyang District, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Containment bag integrity

    Time frame: Immediately after specimen extraction

    Integrity of the specimen containment bag assessed using methylene blue leakage testing following specimen extraction

Secondary outcomes

  1. Specimen extraction time

    Time frame: Periprocedurally

    Duration required to complete transvaginal in-bag electromechanical morcellation and removal of the uterine specimen, measured in minutes.

  2. Total operative time

    Time frame: Immediately after surgery

    Total duration of surgery measured from skin incision to completion of wound closure.

  3. Estimated intraoperative blood loss

    Time frame: During surgery

    Estimated blood loss recorded during the surgical procedure.

  4. Postoperative complications

    Time frame: Up to 30 days postoperatively

    Incidence of postoperative complications including infection, fever, or organ injury.

  5. Length of postoperative hospital stay

    Time frame: Up to 7 days postoperatively

    Number of days from surgery until hospital discharge.

Sponsors and collaborators

Lead sponsor

Chang Zhou

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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