NCT02118974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

April 16, 2014

Last Update Submit

January 18, 2017

Conditions

MenorrhagiaPelvic PainHysterectomy

Keywords

HysterectomyRobot-assistedLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Operative Time

    The primary end point is difference in operative time

    Intra operative

Secondary Outcomes (1)

  • Complications

    up to 6 weeks following intervention

Study Arms (2)

Robot-assisted

EXPERIMENTAL

Robot-assisted hysterectomy

Procedure: Hysterectomy

Laparoscopic Hysterectomy

EXPERIMENTAL

Laparoscopic Hysterectomy

Procedure: Hysterectomy

Interventions

HysterectomyPROCEDURE

Hysterectomy

Laparoscopic HysterectomyRobot-assisted

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing Hysterectomy
  • Able to consent to the procedure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • 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.

    PMID: 28099699DERIVED

MeSH Terms

Conditions

MenorrhagiaPelvic Pain

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow Minimally Invasive GYN Surgery

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)