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Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy

NCT03861195 · University Hospital Tuebingen · Updated 16 May 2024

What is being tested
laparoscopic surgery
For
Uterine Diseases
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 400 people. The full rules are on the registry page.
Where
Germany
When
Starts or started 1 March 2019, ends 30 June 2023. Registered 4 March 2019.
Results
None posted yet.

In the researchers' words

This is a prospective, randomized, single-center, observational clinical trial at the Department of Women's Health of the University Clinic Tübingen. Four hundred patients affected by uterine diseases that undergo treatment with robotic assisted laparoscopic procedures using the Da Vinci Robotic Surgical System (200 patients) or conventional laparoscopic surgery (200 patients) will be recruited. In addition retrospective data of 200 patients that underwent conventional laparoscopic surgery in the past will be documented. At the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the robotic assisted treatment /conventional laparoscopic surgery to multiple access and/or to a laparotomic (open) approach will be documented.
ClinicalTrials.gov, NCT03861195

Sites

  • University Hospital Tuebingen, Department of Women's HealthTübingen, Germany