Comparing robotic and conventional laparoscopic surgery for uterine conditions
Prospective Data Collection to Compare Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy
This study is testing whether robotic surgery is better than traditional laparoscopic surgery for women with uterine conditions by comparing their recovery and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT05613816 on ClinicalTrials.gov |
What this trial studies
This observational clinical trial at the University Hospital Tübingen aims to compare the outcomes of robotic-assisted laparoscopic procedures using the Senhance Surgical System with conventional laparoscopic surgery for patients with uterine diseases. A total of 100 patients undergoing robotic surgery will be compared to 200 patients who have previously undergone conventional surgery for similar conditions. The study will document surgical procedure times, estimated blood loss, complications, and conversion rates to open surgery. Additionally, patients will complete health-related quality of life questionnaires to assess their recovery and satisfaction.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with specific indications for hysterectomy or other uterine/adnexal surgeries.
Not a fit: Patients with extensive intra-abdominal adhesions or contraindications to laparoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the advantages of robotic-assisted surgery over conventional methods, potentially leading to improved surgical outcomes for patients.
How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, suggesting potential benefits, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * indication for other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery: Fibroids, Endometriomas, Cystic masses, Ectopic pregnancies, Sactosalpinx, Inflammatory adnexal disease, Opportunistic salpingectomy as part of hysterectomy or exclusively, Cervico-/Sacrokolpopexy * size of uterus and vagina allows for retrieval by the vaginal route in cancer patients * written informed consent Exclusion Criteria: * 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
Where this trial is running
Tübingen
- University Hospital Tuebingen, Department of Women's Health — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Jürgen Andress, Dr — Department für Frauengesundheit am Universitätsklinikum Tübingen
- Study coordinator: Jürgen Andress, Dr
- Email: Juergen.andress@med.uni-tuebingen.de
- Phone: 07071 29-82211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.