Actively Recruiting

Phase Not Applicable
Age: 35Years - 65Years
FEMALE
ID07226375

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

Age: 35Years - 65Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Sexual inactivity

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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