Minimally Invasive Benign Hysterectomy

Uterine Fibroids Clinical Trial

Official title:

Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865929
• Other study ID #: LundKK
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.

Description:

Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.

Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer

• size of uterus and vagina allows for retrieval by the vaginal route

• maximum uterine size equivalent to 16 weeks of pregnancy

• informed consent

Exclusion Criteria:

• malignant disease

• known extensive intra-abdominal adhesions

• anaesthesiological contraindications to laparoscopic surgery

• women with pacemaker or other implants where electrosurgery is to be avoided

• immunoincompetent women

• simultaneous need for prolapse surgery

• women with known defects of the hemostasis

• allergies towards metronidazole and doxycycline

• inability to understand patient information

Related Conditions & MeSH terms

• Cervical Dysplasia
• Leiomyoma
• Menorrhagia
• Metrorrhagia
• Uterine Cervical Dysplasia
• Uterine Fibroids

Intervention

Device:
• Robotic hysterectomy
Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy

Procedure:
• Vaginal or laparoscopic hysterectomy
Benign hysterectomy performed by traditional minimal invasive procedures.

Locations

Country	Name	City	State
Sweden	Department of Obstetrics and Gynecology, Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social cost	The length of postoperative sick leave and reasons for extending sick leave and cost thereof.	4 months
Primary	Cost of surgery	The cost of surgery includes the actual surgery (anaesthesia, OR-nurse, circulating nurse, doctors and use of the OR) as well as the length of the inpatient stay. The cost for conversions to open surgery, reoperations, readmissions, and any additional cost associated with additional procedures or medical interventions such as radiological examinations and blood transfusions. Based on the estimated cost of surgical material, use of the operating room and cost of anaesthesia each benign hysterectomy performed with robotic surgery would need to be 50 minutes shorter than other minimal invasive procedures to compensate for the additional cost.	4 months
Secondary	Patient outcome	The number of patients in whom an intraoperative or postoperative complication occurs as well as the seriousness of the complication which occurs and what this entails for the patient in question. This includes conversions to open surgery as well as the need for reoperation and readmission.	4 months