Endoscopic Tissue Cutting and Abdominal Extraction Device vs. Conventional Cold Scalpel

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-65
SponsorEge University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Planned laparoscopic hysterectomy

Estimated uterine weight of 500 g or more

Disqualifiers

Sexual inactivity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vaginal tissue morcellation with extraction device

    Device

    Vaginal tissue morcellation after laparoscopic hysterectomy with Endoscopic Tissue Cutting and Abdominal Extraction Device

  • Vaginal tissue morcellation with scalpel

    Device

    Vaginal tissue morcellation after laparoscopic hysterectomy with cold scalpel

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Endoscopic Tissue Cutting and Abdominal Extraction DeviceExperimental treatment 1 intervention
Group B: Conventional Cold ScalpelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Morcellation Time

The time required for complete vaginal morcellation of the uterus, measured from the placement of the uterus into the retrieval bag until complete specimen removal. A shorter duration indicates higher procedural efficiency.

Time frame
From placement of uterus in retrieval bag to complete removal of specimen, measured in minutes (approximately 0-30 minutes).

Secondary outcomes

1

Change in Female Sexual Function Index (FSFI) Score

The change in total Female Sexual Function Index (FSFI) score between the preoperative and postoperative periods will be assessed to evaluate the impact of vaginal morcellation technique on sexual function. The FSFI is a validated questionnaire assessing sexual function in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36, with higher scores indicating better sexual function.

Time frame
Baseline (within 1 week before surgery) and 6 months after operation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ege University

Lead sponsor

Izmir Bakircay University

Sponsor institution