Comparison of Three Robotic Platforms for Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-04

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hysterectomy is the most common procedure in gynaecology after a cesarean section. In recent years, the laparoscopic approach has become preferred given the different advantages over the traditional laparotomic approach, and both conventional laparoscopy and robotic-assisted laparoscopy have become the standard approach for hysterectomy. To date, robotic-assisted laparoscopic hysterectomy has been performed using one robotic platform and only recently, two new robotic platforms have been introduced in clinical practice. Although all three are registered for human use and available for clinical practice, there are currently not enough clinical experiences and data in the literature to evaluate the efficacy, safety and relationship between cost and efficacy of the new platforms available for the robotic-assisted laparoscopic hysterectomy. For this reason, the investigators will conduct an exploratory clinical study on a Post Market Clinical Follow up (PMCF) medical device aimed at performing a preliminary assessment of the global performance of the ITL procedure implemented using the three robotic platforms currently available.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics

NCT01761721

Endometrial Cancer Treatment by Robotic Assisted Laparoscopy Hysterectomy

COMPLETED

Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access

NCT03373513

Activity, Motor Pain Wound

WITHDRAWN NA

Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

NCT03577613

Surgery--Complications

COMPLETED

Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

NCT01258413

Cervical Cancer Postoperative Pain

COMPLETED PHASE3

Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy

NCT02118974

Menorrhagia Pelvic Pain Hysterectomy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hysterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)

Women who undergo robotic-assisted hysterectomy by da Vinci X surgical system, model IS4200 (INTUITIVE)

Robotic-assisted hysterectomy

Intervention Type PROCEDURE

Robotic-assisted hysterectomy following usual surgical technique

Robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)

Women who undergo robotic-assisted hysterectomy by VERSIUS ® surgical system (ROBOTIC SURGICAL SYSTEM)

Robotic-assisted hysterectomy

Intervention Type PROCEDURE

Robotic-assisted hysterectomy following usual surgical technique

Robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)

Women who undergo robotic-assisted hysterectomy by HUGO ™ Robotic Assisted Surgery System (RAS) (MEDTRONIC)

Robotic-assisted hysterectomy

Intervention Type PROCEDURE

Robotic-assisted hysterectomy following usual surgical technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic-assisted hysterectomy

Robotic-assisted hysterectomy following usual surgical technique

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing elective total laparoscopic hysterectomy surgery
* Age \> 18 years
* Signature of the informed consent

Exclusion Criteria

* Patients undergoing emergency surgery
* Patients who are candidates for hysterectomy for a non-gynaecological indication
* Patients undergoing previous radiation therapy
* Patients unable to express adequate informed consent to participate in the study

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No