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

March 18, 2026 updated by: Chang Zhou
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • No. 2, Xinghua East Street, Chaoyang District
      • Beijing, No. 2, Xinghua East Street, Chaoyang District, China
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women undergoing total laparoscopic hysterectomy for enlarged uteri at a single tertiary medical center. Participants include patients with uterine fibroids or adenomyosis and uterine size greater than 12 weeks gestational size who are suitable for transvaginal specimen extraction.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Transvaginal In-Bag Morcellation Group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Zhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

March 1, 2026

Study Completion (Estimated)

March 10, 2026

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-LM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to institutional data protection policies and the potential risk of participant identification in a single-center surgical study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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