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

NCT07486622 | Active Not Recruiting

• 1 other identifier: 2026-LM
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids; Adenomyosis; Enlarged Uterus

Keywords

Uterine Fibroids; Adenomyosis; Enlarged Uterus

Outcome Measures

Primary Outcomes (1)

• Containment bag integrity

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

  Immediately after specimen extraction

Secondary Outcomes (5)

• Specimen extraction time

  Periprocedurally

• Total operative time

  Immediately after surgery

• Estimated intraoperative blood loss

  During surgery

• Postoperative complications

  Up to 30 days postoperatively

• Length of postoperative hospital stay

  Up to 7 days postoperatively

Study Arms (1)

Transvaginal In-Bag Morcellation Group

Eligibility Criteria

• Age: 38 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Zhou: lead

Study Sites (1)

China-Japan Friendship Hospital

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

Location

MeSH Terms

Conditions

Leiomyoma; Adenomyosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 10, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)