Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation

Not Applicable

Recruiting

• Conditions: Gynecologic Surgery

• Registration Number: NCT04392674
• Lead Sponsor: Jing Liang

Brief Summary

The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2020-05-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Pre- and Peri-menopausal woman patient age 18-45 years

  • Women with fibroids and indication for laparoscopic myomectomy.
  • Normal Pap smear result within one year
  • MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
  • The body mass index of the patients is 18.5-27.9kg/m2
  • Signed informed consent form

Exclusion Criteria

• • Women with Known or suspected malignancy

  • patients with severe pelvic adhesion found during the operation
  • The body mass index of the patient ≥ 28kg/m2
  • Diameter of a single uterine fibroid>10cm
  • patients during pregnancy and lactation
  • Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
  • Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
  • Patients who are known to have participated in any other clinical trial within 3 months
  • Patients who cannot sign informed consent
  • Patients with acute stage infection of the reproductive system or other sites

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation	approximately two years	The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage; Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.

Secondary Outcome Measures

Name	Time	Method
The probability of failure during in-bag morcellation procedure	approximately two years	Failure is defined as the operator's inability to successfully insert and extract the device.
The Patients' life quality postoperative	approximately two years	The Patients' life quality postoperative be measured by Questionnaire.
Mean procedure time	approximately two years	Mean procedure time will be measured by hour/minutes.
The Surgeon Task Load Index	approximately two years	The Surgeon Task Load Index be measured by designated Questionnaire.
Intra- or post-operative complications	approximately two years	Intra or post complications rate (e.g. urinary, intestinal or nerve injury)
Estimated blood loss during operation	approximately two years	Blood loss during operation will be measured by volume (mL)
Post-operative pain	approximately two years	Post-operative pain will be measured by Visual Analog Score - VAS

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China