Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy

NCT00485355 | Completed

• 1 other identifier: 07-150
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Fibroids, Menorrhagia, Endometriosis

Keywords

hysterectomy; Laparoscopy; robotics

Outcome Measures

Primary Outcomes (1)

• 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.

  Intra-operative time

Secondary Outcomes (1)

• Peri-operative complications; comparison of costs; qualify of life issues; post-operative pain and narcotic use; return to normal activity

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Conventional Laparoscopic Hysterectomy

Procedure: conventional laparoscopic hysterectomy

2

ACTIVE COMPARATOR

Robotic Assisted Laparoscopic Hysterectomy

Procedure: robotic assisted laparoscopic hysterectomy

Interventions

conventional laparoscopic hysterectomy PROCEDURE

Total laparoscopic hysterectomy

1

robotic assisted laparoscopic hysterectomy PROCEDURE

Robotic assisted laparoscopic hysterectomy with DaVinci robot

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 23395927 RESULT

MeSH Terms

Conditions

Leiomyoma; Menorrhagia; Endometriosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Marie FR Paraiso, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 12, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 19, 2014

Record last verified: 2013-08

Locations

US (1)