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

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03861195
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Diseases	Procedure: laparoscopic surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
• Actual Study Start Date: Mar 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Da Vinci Robotic Surgical System	Procedure: laparoscopic surgery; patients affected by uterine diseases that undergo treatment
conventional laparoscopic surgery	Procedure: laparoscopic surgery; patients affected by uterine diseases that undergo treatment

Outcome Measures

Primary Outcome Measures

1. operative time [60 minutes]

   (minutes from first incision to skin closure)

2. time under narcosis [60 minutes]

3. console time [60 minutes]

4. 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

5. conversion to other surgical procedures [60 minutes]

6. time to discharge [60 minutes]

7. intraoperative complications [60 minutes]

   occurring during the surgical procedure

8. perioperative complications [24 hours]

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

9. postoperative complications [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 [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 [3 and 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Tuebingen, Department of Women's Health	Tuebingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03861195
• Other Study ID Numbers: MT_SOS I
• First Posted: Mar 4, 2019
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Diseases

Study Results

No Results Posted as of Jun 23, 2021