Clinical trial NCT03861195: Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
Official title: Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Diseases
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility 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
* 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

Primary outcomes:
measure: operative time
timeFrame: 60 minutes
measure: time under narcosis
timeFrame: 60 minutes
measure: console time
timeFrame: 60 minutes
measure: estimated blood loss (milliliters)
timeFrame: 60 minutes
measure: conversion to other surgical procedures
timeFrame: 60 minutes
measure: time to discharge
timeFrame: 60 minutes
measure: intraoperative complications
timeFrame: 60 minutes
measure: perioperative complications
timeFrame: 24 hours
measure: postoperative complications
timeFrame: 6 months
measure: German version of the Short Form-36health survey questionnaire Medical Outcomes Trust
timeFrame: 3 and 6 months
measure: German version of the female sexual function index (FSFI) questionnaire
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Women's Health
Study officials:
References: