NCT02049996

Brief Summary

The purpose of this study is to to determine if there is a difference in patient related outcomes of pain and quality of life following vaginal hysterectomy with vaginal prolapse repair compared to robotic-assisted repair. We hypothesize that pain and quality of life following robotic-assisted repair will be similar to that following vaginal reconstruction, when performed in conjunction with vaginal hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

January 28, 2014

Last Update Submit

September 7, 2016

Conditions

Pelvic Organ Prolapse

Keywords

Quality of lifeRobotic surgeryVaginal surgeryProlapse repairVaginal hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Subjective assessment of pain on the morning of post-operative day 1

    Subjective assessment of pain on the morning of post-operative day 1, prior to discharge, on a 150 mm visual analog scale (Surgical Pain Scale) The average pain that day at rest and the WORST pain that day will be the primary outcomes of pain.

    One day (the day after surgery)

Secondary Outcomes (12)

  • Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit

    2 week postoperative visit

  • Subjective assessment of pain at 2 week postoperative visit and 6 week postoperative visit

    6 week postoperative visit

  • Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit

    1 day (Baseline, day of surgery)

  • Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.

    2 week postoperative visit

  • Quality of life at baseline, 2 week postoperative, and 6 week postoperative visit.

    6 week postoperative visit

  • +7 more secondary outcomes

Study Arms (2)

Robotic-assisted prolapse repair

Subjects already scheduled for robotic-assisted prolapse repair in conjunction with vaginal hysterectomy

Vaginal prolapse repair

Subjects already scheduled for vaginal prolapse repair in conjunction with vaginal hysterectomy.

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been scheduled for a vaginal hysterectomy with either vaginal or robot-assisted prolapse repairs with Cincinnati Urogynecology Associates will be approached for participation in the study. Eligible subjects are patients of Cincinnati Urogynecology Associates, aged 18-90, planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse, as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal. All subjects will undergo general anesthesia. Eligible subjects must be able to speak and read English, and be able to understand the informed consent statement.

You may qualify if:

  • patients of Cincinnati Urogynecology Associates
  • aged 18-90
  • planning to undergo a vaginal hysterectomy with robotic or vaginal reconstructive surgery for pelvic organ prolapse as well as a posterior/rectocele repair, with or without a suburethral sling or ovarian removal.
  • undergoing general anesthesia
  • able to speak and read English
  • able to understand the informed consent statement

You may not qualify if:

  • scheduled for repairs not involving a hysterectomy
  • use of mesh in the vaginal prolapse repair
  • obliterative procedures to the vagina
  • concurrent removal of a suburethral sling
  • anterior, posterior or apical vaginal mesh kit at the time of their surgery
  • performance of vaginal 'relaxing incisions' at the time of vaginal surgery
  • concurrent anal incontinence repair such as a sphincteroplasty
  • presence of uterine, cervical or ovarian malignancy
  • use of regional anesthesia for their surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (13)

  • 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. Epub 2008 Mar 6.

    PMID: 18439499BACKGROUND

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

    PMID: 19793478BACKGROUND

  • Orady M, Hrynewych A, Nawfal AK, Wegienka G. Comparison of robotic-assisted hysterectomy to other minimally invasive approaches. JSLS. 2012 Oct-Dec;16(4):542-8. doi: 10.4293/108680812X13462882736899.

    PMID: 23484561BACKGROUND

  • Advincula AP, Xu X, Goudeau S 4th, Ransom SB. Robot-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):698-705. doi: 10.1016/j.jmig.2007.06.008.

    PMID: 17980329BACKGROUND

  • Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.

    PMID: 8694033BACKGROUND

  • McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005 Aug;201(2):245-52. doi: 10.1016/j.jamcollsurg.2005.03.034.

    PMID: 16038823BACKGROUND

  • Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.

    PMID: 9817135BACKGROUND

  • 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. Epub 2010 Mar 5.

    PMID: 20207063RESULT

  • Saceanu S, Cela V, Surlin V, Angelescu CM, Patrascu S, Georgescu I, Genazzani A. Hysterectomy for benign uterine pathology: comparison between robotic assisted laparoscopy, classic laparoscopy and laparotomy. Chirurgia (Bucur). 2013 May-Jun;108(3):346-50.

    PMID: 23790783RESULT

  • Patzkowsky KE, As-Sanie S, Smorgick N, Song AH, Advincula AP. Perioperative outcomes of robotic versus laparoscopic hysterectomy for benign disease. JSLS. 2013 Jan-Mar;17(1):100-6. doi: 10.4293/108680812X13517013317914.

    PMID: 23743379RESULT

  • Robinson BL, Parnell BA, Sandbulte JT, Geller EJ, Connolly A, Matthews CA. Robotic versus vaginal urogynecologic surgery: a retrospective cohort study of perioperative complications in elderly women. Female Pelvic Med Reconstr Surg. 2013 Jul-Aug;19(4):230-7. doi: 10.1097/SPV.0b013e318299a66c.

    PMID: 23797528RESULT

  • Crisp CC, Bandi S, Kleeman SD, Oakley SH, Vaccaro CM, Estanol MV, Fellner AN, Pauls RN. Patient-controlled versus scheduled, nurse-administered analgesia following vaginal reconstructive surgery: a randomized trial. Am J Obstet Gynecol. 2012 Nov;207(5):433.e1-6. doi: 10.1016/j.ajog.2012.06.040. Epub 2012 Jun 20.

    PMID: 22863282RESULT

  • Westermann LB, Crisp CC, Mazloomdoost D, Kleeman SD, Pauls RN. Comparative Perioperative Pain and Recovery in Women Undergoing Vaginal Reconstruction Versus Robotic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):95-100. doi: 10.1097/SPV.0000000000000368.

    PMID: 28067743DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lauren B. Westermann, DO

    TriHealth Good Samaritan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

September 9, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)