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

Uterine Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861195
• Other study ID #: MT_SOS I
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uterine Diseases

Intervention

Procedure:
• laparoscopic surgery
patients affected by uterine diseases that undergo treatment

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Department of Women's Health	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	(minutes from first incision to skin closure)	60 minutes
Primary	time under narcosis		60 minutes
Primary	console time		60 minutes
Primary	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
Primary	conversion to other surgical procedures		60 minutes
Primary	time to discharge		60 minutes
Primary	intraoperative complications	occurring during the surgical procedure	60 minutes
Primary	perioperative complications	occurring less than 24h after the surgical procedure, according to the Clavien-Dindo classification of surgical complications	24 hours
Primary	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
Primary	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
Primary	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