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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal In-Bag Morcellation Group |
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| Measure | Description | Time Frame |
|---|---|---|
| Containment bag integrity | Integrity of the specimen containment bag assessed using methylene blue leakage testing following specimen extraction | Immediately after specimen extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Specimen extraction time | Duration required to complete transvaginal in-bag electromechanical morcellation and removal of the uterine specimen, measured in minutes. | Periprocedurally |
| Total operative time |
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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
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | No. 2, Xinghua East Street, Chaoyang District | China |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2026 | Mar 14, 2026 |
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Total duration of surgery measured from skin incision to completion of wound closure.
| Immediately after surgery |
| Estimated intraoperative blood loss | Estimated blood loss recorded during the surgical procedure. | During surgery |
| Postoperative complications | Incidence of postoperative complications including infection, fever, or organ injury. | Up to 30 days postoperatively |
| Length of postoperative hospital stay | Number of days from surgery until hospital discharge. | Up to 7 days postoperatively |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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