- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008654
Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse
Implementation of ERAS Protocol in Patients Undergoing Surgery for Urinary Incontinence or Pelvic Organ Prolapse
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Please Enter The State Or Province
-
Istanbul, Please Enter The State Or Province, Turkey, 34005
- Kanuni Sultan Suleyman Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse
Exclusion Criteria:
- Insulin dependent diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ERAS group
This groups will receive ERAS protocol
|
Preoperative measures: Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis Avoiding premedication Intraoperative measures: Use of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids) Postoperative: Application of midthoracic, epidural anesthesia/analgesia Refraining from use of nasogastric tube Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization Adherence to the protocol, and auditing results |
Placebo Comparator: Conventional care
This group will not receive the ERAS protocol.
|
This group of patients will not receive the specific ERAS protocol but will receive conventional care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ambulation
Time Frame: Up to 1 week
|
Time to ambulation
|
Up to 1 week
|
Hospital stay
Time Frame: Up to 1month
|
Length of hospital stay
|
Up to 1month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Huseyin2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Ludwig-Maximilians - University of MunichUnknownIncontinence, Overactive Bladder, Stress Urinary IncontinenceGermany
-
San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Copenhagen University Hospital at HerlevZealand University HospitalTerminatedStress Urinary Incontinence | Urge Urinary IncontinenceDenmark
-
ScitonCompletedUrinary Incontinence | Stress Urinary Incontinence | Urge IncontinenceUnited States
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
University of ZurichCompletedStress Urinary Incontinence | Urge Urinary Incontinence
Clinical Trials on ERAS Protocol
-
Children Hospital and Institute of Child Health...Completed
-
University of West AtticaUnknownGynecologic Cancer | Ovarian Cancer | Endometrial Cancer | HysterectomyGreece
-
Wuhan Union Hospital, ChinaRecruitingColorectal Neoplasms | Enhanced Recovery After SurgeryChina
-
West China HospitalCompleted
-
University of Colorado, DenverRecruiting
-
University of Alabama at BirminghamCompleted
-
Alexandria UniversityCompletedSurgery | Lumbar Spine Disease | ERAS | Non Insulin Dependent Diabetes MellitusEgypt
-
Tampere University HospitalTerminatedPancreatic Cancer | Surgery--Complications | Pancreatic Fistula | Delayed Gastric Emptying | Pancreatic HemorrhageFinland
-
University of Milano BicoccaCompletedEnhanced Recovery After Surgery | Emergency SurgeryItaly
-
Johns Hopkins UniversityRecruiting