Clinical trial NCT02118974: Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
Official title: Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Pelvic Pain
Hysterectomy
Keywords: Hysterectomy
Robot-assisted
Laparoscopy
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.

Detailed description: The proposed study will be a non-blinded randomized control trial. Patients will be randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data collection will occur during the following points of patient interaction: pre-operative appointment, the surgical procedure, the patient's hospitalization, first post-operative appointment, and final post-operative appointment.

The care for the patients enrolled in this study will not deviate from the standard care of patients who are currently undergoing laparoscopic and robot-assisted laparoscopic hysterectomy. The patients who present to the office for pre-operative history and physical examination for laparoscopic hysterectomy will be counseled about participation in this study. Basic data collection will commence at the pre-operative visiting, including: patient demographics, past medical history, past surgical history, physical exam findings, and imaging results. The pre-operative appointment will occur between one to thirty days prior to surgery. Intra-operative and immediate post-operative data will be collected by the surgical assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and complications.

Eligibility criteria: Inclusion Criteria:

* Undergoing Hysterectomy
* Able to consent to the procedure

Exclusion Criteria:

1. Medical conditions not allowing for pneumoperitoneum
2. Medical conditions not allowing proper ventilation during anesthesia
3. Pelvic organ prolapse amendable to a vaginal approach
4. Pregnant women
5. Patients undergoing planned combined procedures including bowel resection (other than coincidental appendectomy) or major urologic procedures.

Primary outcomes:
measure: Operative Time
timeFrame: Intra operative
Secondary outcomes:
measure: Complications
timeFrame: up to 6 weeks following intervention
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
References:
citation: Deimling TA, Eldridge JL, Riley KA, Kunselman AR, Harkins GJ. Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy. Int J Gynaecol Obstet. 2017 Jan;136(1):64-69. doi: 10.1002/ijgo.12001. Epub 2016 Nov 3.