Prospective Data Collection to Compare Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy
Study Details
Study Description
Brief Summary
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.
100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System (See Synopsis - Indication A) and are compared to a cohort of 200 patients treated with conventional laparoscopic surgery from a similar ongoing study (Ethics vote: 621 /2018BO1).
100 patients affected by other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery (see Synopsis - Indication B) undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System and are compared to a cohort of 200 patients with indication for other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery (see Synopsis - Indication B) who underwent conventional laparoscopic surgery at the Department of Women's Health in the past.
At the end of patient recruitment, surgical procedure times, 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.
Patients will answer questionnaires (German version of the Short Form-36health survey questionnaire (Medical Outcomes Trust), German version of the female sexual function index (FSFI)) at baseline and at 3 and 6 months of follow-up. A questionnaire for patient satisfaction will be answered one day post procedural, at discharge and at 3 and 6 months follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Senhance Surgical System 100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System |
Procedure: Senhance Surgical System
100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System
|
Outcome Measures
Primary Outcome Measures
- operating time [60 minutes]
time from first incision to skin closure
Secondary Outcome Measures
- time under narcosis [60 minutes]
- console time [60 minutes]
- 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
- conversion to other surgical procedures (e. g. open) [60 minutes]
- time to discharge [60 minutes]
- intraoperative complications [60 minutes]
(occurring during the surgical procedure)
- perioperative complications [24 hours]
(occurring less than 24h after the surgical procedure)
- postoperative complications [6 months]
(occurring more than 24h after the surgical procedure up to 6 months after surgical procedure)
- German version of the Short Form-36health survey questionnaire (Medical Outcomes Trust) [at baseline, and at 3 and 6 months of follow-up]
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 [at baseline, and at 3 and 6 months of follow-up]
female sexual function index: a multidimensional self-report instrument for the assessment of female sexual function
- Questionnaire for patient satisfaction [at one day post procedural, at discharge and at 3 and 6 months follow-up]
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥18 years
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BMI ≤40 kg/m2
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indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
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indication for radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for cervical cancer
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indication for modified radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for endometrial cancer
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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
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size of uterus and vagina allows for retrieval by the vaginal route in cancer patients
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written informed consent
Exclusion Criteria:
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known extensive intra-abdominal adhesions
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anaesthesiological contraindications to laparoscopy
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women with pacemaker or other implants where electrosurgery is to be avoided
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women with known defects of the hemostasis
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pregnancy
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other internal or anatomical criteria that preclude a minimal invasive approach
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inability to understand patient information
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Tuebingen, Department of Women's Health | Tübingen | Germany | 72076 |
Sponsors and Collaborators
- University Hospital Tuebingen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MT_Asensus_Register