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

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04008654

Collaborator

(none)

120

Enrollment

Location

Arms

7.6

Actual Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence Pelvic Organ Prolapse	Behavioral: ERAS Protocol Behavioral: Conventional care	N/A

Detailed Description

ERAS protocols containing several preoperative, intraoperative and postoperative measures have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay in patients undergoing surgery. However, data concerning the role of ERAS protocols in urogynecological surgery is limited. The present study, therefore, aimed to address the role of ERAS protocols in patients undergoing surgery for urinary incontinence and pelvic prolapse.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Implementation of ERAS Protocol in Patients Undergoing Surgery for Urinary Incontinence or Pelvic Organ Prolapse

Actual Study Start Date :

Jul 5, 2019

Actual Primary Completion Date :

Feb 15, 2020

Actual Study Completion Date :

Feb 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ERAS group This groups will receive ERAS protocol	Behavioral: 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.	Behavioral: Conventional care This group of patients will not receive the specific ERAS protocol but will receive conventional care.

Arm

Intervention/Treatment

Active Comparator: ERAS group

This groups will receive ERAS protocol

Behavioral: 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.

Behavioral: Conventional care

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

Outcome Measures

Primary Outcome Measures

Ambulation [Up to 1 week]
Time to ambulation
Hospital stay [Up to 1month]
Length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Insulin dependent diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul	Please Enter The State Or Province	Turkey	34005

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Principal Investigator: Huseyin Kiyak, MD, Kanuni Sultan Suleyman Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huseyin Kiyak, Principal Investigator, M.D., Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04008654

Other Study ID Numbers:

Huseyin2

First Posted:

Jul 5, 2019

Last Update Posted:

Feb 20, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Feb 20, 2020