Comparison of Endoscopic Tissue Cutting and Abdominal Extraction Device With Conventional Cold Scalpel

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of the study is to compare the surgical tissue removal success of the endoscopic tissue cutting device, which was designed by the conductor and developed with the support of TUBITAK-1512 project and for which Turkish and European patent applications were made, with the conventional cold scalpel. Laparoscopic surgeries are performed through incisions ranging from 0.5 cm to 1 cm. After the operation, much larger masses need to be removed from the abdomen compared to these incisions. Currently, in laparoscopic surgery, masses are removed from the abdomen by cutting them into pieces with a scalpel, using electrical devices called power morcellators that are used to cut the tissue/mass with rotational movement and remove it from the abdomen, and directly removing the mass from the abdomen through an incision made as large as the size of the mass. Trying to remove large tissues/mass by dissecting them with a scalpel through incisions that are 1.5-2 cm wide and limit the surgeon's range of motion is quite laborious, tiring, time-consuming and risky. In the use of Power Morcellator disintegrator devices, there is a risk of the pieces of the mass spreading into the abdomen while cutting and separating the tissue/mass that is being removed into small pieces due to the rotational movement in the working principle. In operations where the Power Morcellator device is used, if the removed tissue is malignant (cancerous), the patient faces the risk of metastasis spreading to the entire abdomen. Due to these risks, the use of power morcellator devices has been completely banned in the United States, and in European Union countries, it has been required that the device be operated in protective bags. The invention is a medical device that will allow large masses to be removed quickly, safely and easily through small incisions in closed surgeries. The device offers an effective solution to the problems of the current technique. Within the scope of the study, the morcellator scissors and the scalpel, which are designed and started to be mass-produced, will be compared in the morcellation (removal by separating into pieces) process to be performed during the removal of the mass from the vagina after laparoscopic hysterectomy surgeries, and the morcellation time, possible complications and the possible effects of the device to be used on the case will be investigated.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: f
View:

• Planned laparoscopic hysterectomy

• Estimated uterine weight of 500 g or more

Locations
Other Locations
Turkey
Izmir Bakircay University
RECRUITING
Izmir
Contact Information
Primary
Sabahattin A Arı, Associate Professor
s.anil.ari.md@gmail.com
+905547139994
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2026-12-17
Participants
Target number of participants: 84
Treatments
Experimental: Endoscopic Tissue Cutting and Abdominal Extraction Device
In the cases included in the group, vaginal morcellation will be performed with an endoscopic tissue cutting and removal device after laparoscopic hysterectomy.
Active_comparator: Conventional Cold Scalpel
In the cases included in the group, vaginal morcellation will be performed with a cold scalpel after laparoscopic hysterectomy.
Related Therapeutic Areas
Sponsors
Leads: Ege University

This content was sourced from clinicaltrials.gov