Clinical trial NCT06138197: Comparison of Three Robotic Platforms for Hysterectomy
Official title: Comparative Evaluation of Three Surgical Robotic Platforms for the Laparoscopic Hysterectomy Procedure: Post Market Clinical Follow Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Keywords: Hysterectomy
Gynecologic pathology
Robotic-assisted laparoscopy
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women undergoing robotic-assisted elective total laparoscopic hysterectomy

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Textbook outcome satisfaction
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Intraoperative complications
timeFrame: During surgery
measure: Postoperative complications
timeFrame: 30 and 90 days after surgery
measure: Operative time
timeFrame: During surgery
measure: Intraoperative blood loss
timeFrame: During surgery
measure: Sexual function
timeFrame: 90 and 180 days after surgery
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Study officials:
affiliation: Universita di Verona
name: Stefano Uccella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Simone Garzon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Pier Carlo Zorzato, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.