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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.

Study Description
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Brief Summary:
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse PONV Drug: Dexamethasone Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
Study Start Date : February 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexamethasone
Dexamethasone
 Drug: Dexamethasone
Dexamethasone 8mg/IV
Placebo Comparator: Placebo
Sterile normal saline solution
 Drug: Placebo
Placebo given IV


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073734


Locations
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United States, Ohio
Triheath
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Study Director: Rachel N Pauls, MD TriHealth Good Samaritan Hospital
Principal Investigator: Rachel N Pauls, MD TriHeath Good Samaritan Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02073734    
Other Study ID Numbers: 12136-12-081
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by TriHealth Inc.:
pelvic organ prolapse surgery
dexamethasone
postoperative nausea and vomiting
peroperative administration
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents