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

NCT03861195 | Completed

• 1 other identifier: MT_SOS I
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Diseases

Outcome Measures

Primary Outcomes (11)

• operative time

  (minutes from first incision to skin closure)

  60 minutes

• time under narcosis

  60 minutes

• console time

  60 minutes

• estimated blood loss (milliliters)

  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

  60 minutes

• conversion to other surgical procedures

  60 minutes

• time to discharge

  60 minutes

• intraoperative complications

  occurring during the surgical procedure

  60 minutes

• perioperative complications

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

  24 hours

• postoperative complications

  occurring more than 24h after the surgical procedure up to 6 months after surgical procedure, according to the Clavien-Dindo classification of surgical complications

  6 months

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

  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.

  3 and 6 months

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

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

  3 and 6 months

Study Arms (2)

Da Vinci Robotic Surgical System

Procedure: laparoscopic surgery

conventional laparoscopic surgery

Procedure: laparoscopic surgery

Interventions

laparoscopic surgery PROCEDURE

patients affected by uterine diseases that undergo treatment

Da Vinci Robotic Surgical System; conventional laparoscopic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Uterine Diseases

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 4, 2019
• Study Start: March 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-02

Locations

DE (1)