An interventional study of Enhanced recovery after surgery (ERAS) protocol in Urinary Incontinence, Cystocele and Rectocele, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Treatment
Enhanced recovery after surgery (ERAS) has been shown to improve postoperative outcomes in a variety of surgical conditions. However, data regarding its role in urogynecologic surgery is limited. This study aimed to investigate the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.
Enhanced recovery after surgery (ERAS) or in other words "fast-track" protocol roughly purposes to improve patient satisfaction, reduce complications and shorten the hospital stay. Chronic diseases, nutrition, and any volume depletion are corrected prior to surgery and less invasive surgical techniques are utilized to this end The impact of ERAS protocols in decreasing length of stay (LOS), reducing postoperative pain, improving early ambulation and decreasing the rate of potentially serious medical complications have been studied in patients undergoing colorectal, urologic, gastric and pancreatic surgery previously. However, data regarding the role of ERAS protocol in improving postoperative outcomes and postoperative compliance in patients undergoing urogynecological surgery is limited.
The present study purposes to clarify the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's enrollment of 125 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 225 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
A standardized ERAS protocol is applied to the ERAS group based on the latest guidelines. Smoking and alcohol consumption is stopped 4 weeks before the surgery. Preoperative anemia is corrected with intravenous iron supplementation. Prolonged fasting, bowel preparation, and premedication are avoided in this group. Clear fluids are allowed up to 2 h and solids rich in carbohydrate up to 6 h hours prior to induction of anesthesia. Warmed up intravenous fluids are administered to maintain normothermia intraoperatively. This group of subjects receives general anesthesia. Volume and salt overload and drain usage are avoided to the utmost. Intravenous paracetamol is administered for postoperative analgesia before the completion of the surgical procedure. Nasogastric tube placement is avoided and catheters are removed as soon as possible. Nonopioid oral analgesics and NSAIDs are utilized for postoperative pain medication.
Procedure: Enhanced recovery after surgery (ERAS) protocol
This group will receive conventional pre-and postoperative care.
Preoperative: 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: Use of short-acting anesthetic agents Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids) Postoperative: Refraining from the 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
Time to ambulation
Hours
Time frame: Up to 1 week
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Dec 2019, 4 months.
Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 4 months is below that.
Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Kanuni Sultan Suleyman Training and Research Hospital →