Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
- Conditions
- Uterine Diseases
- Interventions
- Procedure: laparoscopic surgery
- Registration Number
- NCT03861195
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
- age ≥18 years
- BMI ≤40 kg/m2
- indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
- indication for radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for cervical cancer
- indication for modified radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for endometrial cancer
- size of uterus and vagina allows for retrieval by the vaginal route in cancer patients
- written informed consent
- known extensive intra-abdominal adhesions
- anaesthesiological contraindications to laparoscopy
- women with pacemaker or other implants where electrosurgery is to be avoided
- women with known defects of the hemostasis
- pregnancy
- other internal or anatomical criteria that preclude a minimal invasive approach
- inability to understand patient information
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Da Vinci Robotic Surgical System laparoscopic surgery - conventional laparoscopic surgery laparoscopic surgery -
- Primary Outcome Measures
Name Time Method console time 60 minutes German version of the Short Form-36health survey questionnaire Medical Outcomes Trust 3 and 6 months 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.
German version of the female sexual function index (FSFI) questionnaire 3 and 6 months female sexual function index: a multidimensional self-report instrument for the assessment of female sexual function
time to discharge 60 minutes intraoperative complications 60 minutes occurring during the surgical procedure
postoperative complications 6 months occurring more than 24h after the surgical procedure up to 6 months after surgical procedure, according to the Clavien-Dindo classification of surgical complications
operative time 60 minutes (minutes from first incision to skin closure)
estimated blood loss (milliliters) 60 minutes 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
perioperative complications 24 hours occurring less than 24h after the surgical procedure, according to the Clavien-Dindo classification of surgical complications
time under narcosis 60 minutes conversion to other surgical procedures 60 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Tuebingen, Department of Women's Health
🇩🇪Tuebingen, Germany