Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

Endometriosis Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01581905
• Other study ID #: 38824
• Status: Terminated
• Phase: N/A
• First received: February 24, 2012
• Last updated: January 19, 2017
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has also shown the complication rates for laparoscopic cases are similar to open procedures in the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to decrease the learning curve and increase the availability of minimally invasive surgery to patients. A current review of the literature reveals no randomized trials evaluating the efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to address this void.

The primary objective of this study is to determine whether Robot-Assisted Laparoscopic Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to operative time, blood loss, and hospital stay. The investigator's secondary objective was to assess the cost, morbidity, and mortality of each procedure.

Description:

See Above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individuals recruited into this study will be patients presenting to the Urogynecology and Minimally Invasive Surgical Group for consultation for hysterectomy.

Exclusion Criteria:Individuals who are not candidates for laparoscopic surgery

• Medical Condition that does not allow pneumoperitoneum

• Medical Condition that does not allow proper ventilation during anesthesia

• Uterine size precluding access to the uterine artery

• Pelvic Organ Prolapse amendable to a vaginal approach

Related Conditions & MeSH terms

• Dysfunctional Uterine Bleeding
• Endometriosis
• Leiomyoma
• Menorrhagia
• Metrorrhagia
• Pelvic Pain
• Uterine Hemorrhage

Intervention

Procedure:
• Conventional Laparoscopic Hysterectomy (LH)
Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
• Robot Assisted Hysterectomy
Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Pasic RP, Rizzo JA, Fang H, Ross S, Moore M, Gunnarsson C. Comparing robot-assisted with conventional laparoscopic hysterectomy: impact on cost and clinical outcomes. J Minim Invasive Gynecol. 2010 Nov-Dec;17(6):730-8. doi: 10.1016/j.jmig.2010.06.009. — View Citation

Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008. — View Citation

Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. — View Citation

Sarlos D, Kots LA. Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr Opin Obstet Gynecol. 2011 Aug;23(4):283-8. doi: 10.1097/GCO.0b013e328348a26e. Review. — View Citation

Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating Time		Operating time is measured on the day of surgery after completing the procedure.
Secondary	Estimated Blood Loss		Estimated blood loss will be measured on the day of surgery after completing the procedure.
Secondary	Intraoperative Complications	Intraoperative complications include: injury to bladder, ureters, bowel, blood vessels,and nerves AND hemorrhage	Intraoperative complications will be measured on the day of surgery after completing the procedure.
Secondary	Perioperative Complications	Perioperative complications include: urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE)	Perioperative complications will be measured on the date of discharge from the hospital.
Secondary	Early Postoperative Complications	Early postoperative complications include: pulmonary, renal, and cerebrovascular morbidity, wound and vault complications (infection, breakdown, and dehiscence); septicemia, and thromboembolic complications (DVT, PE)	Early postoperative complications will be measured on the date of discharge from the hospital until two weeks after surgery, assessed up to 14 days post-operativley.
Secondary	Delayed Post-Operative Complications	Delayed post-operative complications include: incisional hernia formation, re-operation, vaginal evisceration	Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively.
Secondary	Costs	Costs will include the costs of pre-operative care, surgery, post-operative care, and any post-operative complications.	Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively.