An observational study in Uterine Diseases, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University Hospital Tuebingen · Observational
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.
66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.
This study's enrollment of 400 is above the median of 168 across 12 observational studies indexed under Uterine Diseases.
Browse Uterine Diseases studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
primary care clinic
Exclusion Criteria:
Procedure: laparoscopic surgery
Procedure: laparoscopic surgery
patients affected by uterine diseases that undergo treatment
operative time
(minutes from first incision to skin closure)
Time frame: 60 minutes
time under narcosis
Time frame: 60 minutes
console time
Time frame: 60 minutes
estimated blood loss (milliliters)
using the following formula: ((Hemoglobin concentration preoperative (g/l)) - (Hemoglobin 1st day postoperative (g/l)))/((Hemoglobin preoperative (g/l)) - (Hemoglobin 1st day postoperative (g/l)))/2) × 1000
Time frame: 60 minutes
conversion to other surgical procedures
Time frame: 60 minutes
time to discharge
Time frame: 60 minutes
intraoperative complications
occurring during the surgical procedure
Time frame: 60 minutes
perioperative complications
occurring less than 24h after the surgical procedure, according to the Clavien-Dindo classification of surgical complications
Time frame: 24 hours
postoperative complications
occurring more than 24h after the surgical procedure up to 6 months after surgical procedure, according to the Clavien-Dindo classification of surgical complications
Time frame: 6 months
German version of the Short Form-36health survey questionnaire Medical Outcomes Trust
Medical Outcomes Trust: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.
Time frame: 3 and 6 months
German version of the female sexual function index (FSFI) questionnaire
female sexual function index: a multidimensional self-report instrument for the assessment of female sexual function
Time frame: 3 and 6 months
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Tuebingen