Comparison of Three Robotic Platforms for Hysterectomy

Hysterectomy Clinical Trial

— COMPAR-HYST  

Official title:

Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138197
• Other study ID #: COMPAR-HYST
• Status: Recruiting
• Start date: January 4, 2024
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Universita di Verona
• Contact: Stefano Uccella, MD, PhD
• Phone: 0039 045 812 2720
• Email: stefano.uccella[@]univr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• Robotic-assisted hysterectomy
Robotic-assisted hysterectomy following usual surgical technique

Locations

Country	Name	City	State
Italy	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5. — View Citation

Lawrie TA, Liu H, Lu D, Dowswell T, Song H, Wang L, Shi G. Robot-assisted surgery in gynaecology. Cochrane Database Syst Rev. 2019 Apr 15;4(4):CD011422. doi: 10.1002/14651858.CD011422.pub2. — View Citation

Monterossi G, Pedone Anchora L, Gueli Alletti S, Fagotti A, Fanfani F, Scambia G. The first European gynaecological procedure with the new surgical robot Hugo RAS. A total hysterectomy and salpingo-oophorectomy in a woman affected by BRCA-1 mutation. Facts Views Vis Obgyn. 2022 Mar;14(1):91-94. doi: 10.52054/FVVO.14.1.014. — View Citation

Nobbenhuis MAE, Gul N, Barton-Smith P, O'Sullivan O, Moss E, Ind TEJ; Royal College of Obstetricians and Gynaecologists. Robotic surgery in gynaecology: Scientific Impact Paper No. 71 (July 2022). BJOG. 2023 Jan;130(1):e1-e8. doi: 10.1111/1471-0528.17242. Epub 2022 Jul 17. — View Citation

Torpy JM, Lynm C, Glass RM. JAMA patient page. Hysterectomy. JAMA. 2004 Mar 24;291(12):1526. doi: 10.1001/jama.291.12.1526. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Textbook outcome satisfaction	Robotic-assisted hysterectomy performed without laparotomy conversion, intraoperative complications, postoperative complications (Clavien-Dindo classification =2), the performance of postoperative imaging excluding transvaginal ultrasound, reoperation, length of stay after day of surgery >2 days, readmission within 90 days, mortality, surgery length greater than 120 minutes, or intraoperative blood loss greater than 100mL. The Textbook outcome will be considered fulfilled if all conditions are met.	90 days after surgery
Secondary	Intraoperative complications	Intraoperative complications graded based on the Clavien-Dindo classification	During surgery
Secondary	Postoperative complications	Postoperative complications graded based on the Clavien-Dindo classification	30 and 90 days after surgery
Secondary	Operative time	Time between first incision and skin closure	During surgery
Secondary	Intraoperative blood loss	Total blood aspirate during the surgical procedure	During surgery
Secondary	Sexual function	The female sexual function index (FSFI) consists of 19 multiple-choice items that assess female sexual functioning based on 6 domains: desire, arousal, orgasm, pain, sexual satisfaction, and lubrication. The total score ranges from 0 to 36, with 26.55 as the cut-off suggesting the presence of sexual dysfunction. The higher the score, the better the sexual function.	90 and 180 days after surgery