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NCT Number: NCT03861195

Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy

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.

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Key information

Conditions

Uterine Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic surgery

Procedure

patients affected by uterine diseases that undergo treatment

Primary outcomes

  1. operative time

    Time frame: 60 minutes

    (minutes from first incision to skin closure)

  2. time under narcosis

    Time frame: 60 minutes

  3. console time

    Time frame: 60 minutes

  4. estimated blood loss (milliliters)

    Time frame: 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

  5. conversion to other surgical procedures

    Time frame: 60 minutes

  6. time to discharge

    Time frame: 60 minutes

  7. intraoperative complications

    Time frame: 60 minutes

    occurring during the surgical procedure

  8. perioperative complications

    Time frame: 24 hours

    occurring less than 24h after the surgical procedure, according to the Clavien-Dindo classification of surgical complications

  9. postoperative complications

    Time frame: 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

  10. German version of the Short Form-36health survey questionnaire Medical Outcomes Trust

    Time frame: 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.

  11. German version of the female sexual function index (FSFI) questionnaire

    Time frame: 3 and 6 months

    female sexual function index: a multidimensional self-report instrument for the assessment of female sexual function

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2019
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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