Endoscopic cutting and abdominal extraction device versus conventional scalpel for removing large uterine tissue during laparoscopic hysterectomy
Comparison of Endoscopic Tissue Cutting and Abdominal Extraction Device With Conventional Cold Scalpel
This trial will test whether a new endoscopic cutting and extraction device can remove large uterine tissue faster and with fewer complications than the usual scalpel for people having laparoscopic hysterectomy with an estimated uterine weight of 500 g or more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | Female |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (Izmir) |
| Trial ID | NCT07226375 on ClinicalTrials.gov |
What this trial studies
The trial compares vaginal tissue morcellation using a novel endoscopic cutting and abdominal extraction device to conventional scalpel morcellation in people undergoing planned laparoscopic hysterectomy. Participants meet inclusion criteria including an estimated uterine weight of at least 500 grams and will undergo tissue extraction with one of the two techniques during their operation. Key outcomes include successful tissue removal, extraction time, need to enlarge incisions or convert to open surgery, and surgical complications. The device is a patented design developed with TUBITAK support and the procedure is being performed at an Izmir surgical site affiliated with Ege University.
Who should consider this trial
Good fit: People scheduled for laparoscopic hysterectomy with an estimated uterine weight of 500 g or more who are sexually active and can have their operation at the Izmir site are the intended participants.
Not a fit: People with smaller uteri (under 500 g), those who are sexually inactive, or those unable to travel to Izmir are unlikely to be eligible or benefit from this trial.
Why it matters
Potential benefit: If successful, the device could speed up tissue removal, reduce the need to enlarge incisions or convert to open surgery, and shorten recovery time.
How similar studies have performed: Conventional scalpel morcellation and power morcellators are established but have limitations and risks, while this specific endoscopic extraction device is novel and has limited prior clinical outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned laparoscopic hysterectomy * Estimated uterine weight of 500 g or more Exclusion Criteria: * Sexual inactivity
Where this trial is running
Izmir
- Izmir Bakircay University — Izmir, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sabahattin A Arı, Associate Professor
- Email: s.anil.ari.md@gmail.com
- Phone: +905547139994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.