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Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073734
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Tracking Information
First Submitted Date  ICMJE April 25, 2013
First Posted Date  ICMJE February 27, 2014
Last Update Posted Date April 21, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2014)		 The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). [ Time Frame: up to 20-24 hours after surgery ]
The QoR-40 is a validated standardized questionnaire that assesses the dimensions of physical functioning, mental health, cognitive functioning, symptoms, role and social functioning, general health perceptions, sleep and energy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2014)		 To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain. [ Time Frame: 20-24 hours after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
Official Title  ICMJE Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
Brief Summary The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.
Detailed Description This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Pelvic Organ Prolapse
  • PONV
Intervention  ICMJE
  • Drug: Dexamethasone
    Dexamethasone 8mg/IV
  • Drug: Placebo
    Placebo given IV
Study Arms  ICMJE
  • Experimental: Dexamethasone
    Dexamethasone
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Placebo
    Sterile normal saline solution
    Intervention: Drug: Placebo
Publications * Pauls RN, Crisp CC, Oakley SH, Westermann LB, Mazloomdoost D, Kleeman SD, Ghodsi V, Estanol MV. Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial. Am J Obstet Gynecol. 2015 Nov;213(5):718.e1-7. doi: 10.1016/j.ajog.2015.05.061. Epub 2015 May 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)		 63
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2014)		 62
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy

Exclusion Criteria:

  • Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
  • Regional anesthesia for surgical procedure
  • Chronic pain requiring opioid treatment daily
  • History of allergy to the study medication
  • Severe renal and liver disease
  • Pregnancy
  • Non English speaking
  • Psychiatric disorder that will preclude completion of questionnaires
  • Minor surgery that does not involve overnight admission
  • Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
  • Hypersensitivity reaction to steroids
  • Evidence of systemic fungal infection
  • Evidence of any systemic infection
  • Uncontrolled diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02073734
Other Study ID Numbers  ICMJE 12136-12-081
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party TriHealth Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE TriHealth Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rachel N Pauls, MD TriHealth Good Samaritan Hospital
Principal Investigator: Rachel N Pauls, MD TriHeath Good Samaritan Hospital
PRS Account TriHealth Inc.
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP