Actively Recruiting
Comparison of Endoscopic Tissue Cutting and Abdominal Extraction Device With Conventional Cold Scalpel for Laparoscopic Hysterectomy
Led by Ege University · Updated on 2025-11-14
84
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new endoscopic tissue cutting and abdominal extraction device designed to remove large tissue masses safely and efficiently during laparoscopic hysterectomy surgeries. This study compares the new device with the conventional cold scalpel for removing uterine tissue. The goal is to improve the process of tissue removal, which is challenging due to the small size of surgical incisions compared to the larger size of tissues that need to be extracted. Participants will receive one of two treatments during their laparoscopic hysterectomy: tissue removal using the new endoscopic cutting device or tissue removal using the standard cold scalpel. The device is designed to cut tissue without rotational movement and keep the pieces contained, aiming to reduce the risk of tissue spreading in the abdomen. The study will measure the time it takes to remove tissue and monitor for possible complications. During the study, participants will be assessed on how long the tissue removal process takes from placing the uterus in a retrieval bag until complete removal. Additionally, sexual function will be evaluated before surgery and six months afterward using the Female Sexual Function Index (FSFI). Researchers will also monitor for any complications related to the procedures. The study period includes treatment and follow-up assessments, with careful monitoring of surgical outcomes and patient well-being.
CONDITIONS
Brief Title
Endoscopic Tissue Cutting and Abdominal Extraction Device vs. Conventional Cold Scalpel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned laparoscopic hysterectomy
- Estimated uterine weight of 500 g or more
- Female aged between 35 and 65 years
- Sexually active
You will not qualify if you...
- Sexual inactivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus hospital stay duration
Participants undergo laparoscopic hysterectomy surgery followed by vaginal tissue morcellation using either the endoscopic tissue cutting and abdominal extraction device or the conventional cold scalpel.
1 surgical procedure visit and hospital stay
Duration - 6 months
Participants are followed for recovery and assessment including evaluation of sexual function 6 months after the operation.
Baseline visit before surgery and 1 follow-up visit at 6 months
Trial Site Locations
Total: 1 location
1
Izmir Bakircay University
Izmir, Turkey (Türkiye), 35665
Actively Recruiting
Research Team
S
Sabahattin A Arı, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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