Trial record 9 of 252 for:    hysterectomy

Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00485355
First received: June 11, 2007
Last updated: February 18, 2014
Last verified: August 2013
  Purpose

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


Condition Intervention
Uterine Fibroids, Menorrhagia, Endometriosis
Procedure: conventional laparoscopic hysterectomy
Procedure: robotic assisted laparoscopic hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Conventional vs. Robotic Assisted Laparoscopic Hysterectomy

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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. [ Time Frame: Intra-operative time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peri-operative complications; comparison of costs; qualify of life issues; post-operative pain and narcotic use; return to normal activity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: June 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Conventional Laparoscopic Hysterectomy
Procedure: conventional laparoscopic hysterectomy
Total laparoscopic hysterectomy
Active Comparator: 2
Robotic Assisted Laparoscopic Hysterectomy
Procedure: robotic assisted laparoscopic hysterectomy
Robotic assisted laparoscopic hysterectomy with DaVinci robot

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485355

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Marie FR Paraiso, MD The Cleveland Clinic
  More Information

Publications:
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00485355     History of Changes
Other Study ID Numbers: 07-150
Study First Received: June 11, 2007
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
hysterectomy
Laparoscopy
robotics

Additional relevant MeSH terms:
Endometriosis
Leiomyoma
Menorrhagia
Myofibroma
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Pathologic Processes
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 16, 2014