Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse

NCT04008654 | Completed

• 1 other identifier: Huseyin2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

ERAS protocols have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS protocol on time to mobilization and length of hospital stay in patients undergoing surgery for urinary incontinence and pelvic prolapse.

Conditions

Urinary Incontinence; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Ambulation

  Time to ambulation

  Up to 1 week

• Hospital stay

  Length of hospital stay

  Up to 1month

Study Arms (2)

ERAS group

ACTIVE COMPARATOR

This groups will receive ERAS protocol

Behavioral: ERAS Protocol

Conventional care

PLACEBO COMPARATOR

This group will not receive the ERAS protocol.

Behavioral: Conventional care

Interventions

ERAS Protocol BEHAVIORAL

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

ERAS group

Conventional care BEHAVIORAL

This group of patients will not receive the specific ERAS protocol but will receive conventional care.

Conventional care

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse

You may not qualify if:

• Insulin dependent diabetes

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Study Officials

• Huseyin Kiyak, MD

  Kanuni Sultan Suleyman Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: June 30, 2019
• First Posted: July 5, 2019
• Study Start: July 5, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 20, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)