Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy

NCT ID: NCT00485355

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to compare two ways of performing laparoscopic hysterectomy - robotic-assisted vs. conventional laparoscopy.

Detailed Description

Compared to abdominal hysterectomy, the advantages of laparoscopic hysterectomy are decreased postoperative intravenous analgesia requirements, shorter length of hospital stay, quicker return to work and daily activities. Longer operating times have been shown to be offset by shorter hospital stays, with similar hospital costs overall. Compared to abdominal hysterectomy, laparoscopic hysterectomy is associated with less blood loss, fewer abdominal wall infections, or febrile episodes. The increased visualization allows for concomitant evaluation and excision of adhesions or endometriosis, as well as facilitating oophorectomy.

Robotic systems were developed in order to facilitate laparoscopy by more ergonomic movements that are easier to perform and more precise. The da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) has endowrist instruments that have seven degrees of movement and mimic the human wrist. It can also filter out tremors and other unintentional hand motions that may result from prolonged holding of instruments. The surgeon seated at a console commands the laparoscope and two laparoscopic surgical instruments.

In the literature, several case series have described the use of robotic-assisted hysterectomy. Two of these series included patients that were undergoing surgery for suspected malignancy, and hence has a different patient population that we are going to enroll.Overall these studies have demonstrated the feasibility of using robot-enhanced technology in order to perform hysterectomy in series of approximately 10-20 patients, with a similar rate of complications compared to classical laparoscopy.

The objective of this study is to conduct a prospective randomized controlled trial of robotic assisted versus traditional hysterectomy in the treatment of patients who have benign indications for hysterectomy, e.g. menorrhagia, symptomatic fibroid uteri, etc. Our primary outcome is operative time from incision to either closure or, in the case of concomitant prolapse or incontinence procedures, the completion of the hysterectomy portion of the case, i.e. closure of vaginal cuff and achievement of hemostasis from the hysterectomy. Secondary outcomes include intra-operative, peri-operative, and post-operative complications; post-operative patient outcomes as measured by the Short Form 36 (SF-36) questionnaire. Patient scores on this questionnaire before and after surgery can be used to calculate the quality adjusted life years (QALYs), which can then be used in the cost utility analysis. Patients' overall narcotic use and quality of life will also be assessed after surgery with diaries at different intervals. The diaries will consist of a daily narcotic/pain medication diary, a weekly assessment of return to normal activity, and assessments at 2, 4, and 6 weeks of surgical pain and ability to perform functional activities.

Conditions

Uterine Fibroids, Menorrhagia, Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Conventional Laparoscopic Hysterectomy

Group Type: ACTIVE_COMPARATOR

conventional laparoscopic hysterectomy

Intervention Type: PROCEDURE

Total laparoscopic hysterectomy

2

Robotic Assisted Laparoscopic Hysterectomy

Group Type: ACTIVE_COMPARATOR

robotic assisted laparoscopic hysterectomy

Intervention Type: PROCEDURE

Robotic assisted laparoscopic hysterectomy with DaVinci robot

Interventions

conventional laparoscopic hysterectomy

Total laparoscopic hysterectomy

Intervention Type: PROCEDURE

robotic assisted laparoscopic hysterectomy

Robotic assisted laparoscopic hysterectomy with DaVinci robot

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• women who are 18 years of age or greater who are to undergo laparoscopic hysterectomy for benign indications. Other concomitant laparoscopic or anti-incontinence procedures (e.g., excision of endometriosis or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.

Exclusion Criteria

• suspected malignancy, medical illness precluding laparoscopy, inability to give informed consent, morbid obesity (BMI>40), or need for concomitant bowel resection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie FR Paraiso, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Paraiso MF, Ridgeway B, Park AJ, Jelovsek JE, Barber MD, Falcone T, Einarsson JI. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. Am J Obstet Gynecol. 2013 May;208(5):368.e1-7. doi: 10.1016/j.ajog.2013.02.008. Epub 2013 Feb 8.

Reference Type: RESULT

PMID: 23395927 (View on PubMed)

Other Identifiers

07-150

Identifier Type: -

Identifier Source: org_study_id