ERAC Protocol in Elective Cesarean Surgery (Erac)

"Evaluation of Elective Cesarean Surgery Within the Scope of ERAC Protocol: Where Are We in Türkiye"

This descriptive prospective study was conducted between 01/12/2021-01/09/2022. The sample of the study consisted of 333 women who underwent elective cesarean section (CS). Nurse observation form, anesthesia follow-up form, patient file and verbal expressions of women were used to collect data. Number, percentage, mean and standard deviation were used as descriptive statistics.

Study Overview

• Status: Completed
• Conditions: Enhanced Recovery After Surgery; Cesrean Delivery
• Intervention / Treatment: Procedure: ERAC protocol

Detailed Description

A descriptive prospective study was conducted in the Gynecology and Obstetrics branch hospital between 01/12/2021-01/09/2022. The universe of the study consisted of pregnant women who underwent elective CS in the relevant hospital. The study sample consisted of 333 patients who underwent elective CS with the sample calculation method when the universe was known (N: Number of individuals in the population (2500), p: Incidence of the investigated event (0.5), q: Incidence of the examined event (0.5), t: Certain theoretical value found in the "t" table at the degree of freedom and the detected error level (1.96), d: Sensitivity to be made according to the incidence of the event (0.05), 0.95 confidence interval, 0.05 margin of error).

The period of the study group was followed from hospitalization to discharge. The data collection form prepared by scanning the literatüre1-6 was used to collect the research data. The data collection form consisted of two parts. In the first part, there were questions about the socio-demographic and obstetric characteristics of the participant, and in the second part, questions about the components of the ERAC protocol. Nurse observation form, anesthesia follow-up form, patient file and verbal expressions of women were used to collect data. In the research, data related to health practices were taken from the file and recorded. Inclusion criteria; women who agreed to participate in the study, who were hospitalized in the CS, and who had elective CS surgery. Women who did not have elective CS and did not accept participation in the study are exclusion criteria.

Ethics committee approval was obtained from the clinical research ethics committee for the study and informed consent was obtained from the participants.

The analysis of the data was done in computer environment with SPSS (Statistical Package for the Social Sciences) 20.0 ready-made statistical program. In the evaluation of the data; number, percentage, mean and standard deviation were used as descriptive statistics.

• Study Type: Observational
• Enrollment (Actual): 333

Contacts and Locations

Study Locations

• Turkey
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06010
      • Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

women who had elective CS surgery in the XX hospital

Description

Inclusion Criteria:

• Inclusion criteria; women who agreed to participate in the study, who were hospitalized in the CS, and who had elective CS surgery

Exclusion Criteria:

• Women who did not have elective CS and did not accept participation in the study are exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

cesarean delivery; women undergoing elective caesarean section

Procedure: ERAC protocol; our study aimed to evaluate pre-peri-post operative practices in women who underwent elective cesarean section (CS) according to the ERAC protocol. In this context, this study aimed to describe the implementation status of the recommendations regarding the ERAC protocol in CS operations, to identify the missing aspects of the ERAC protocol and to raise awareness about its benefits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative applications	Sedative premedication Yes No	from december 2021 to september 2022
Preoperative information	Preoperative IV fluid ......cc	from december 2021 to september 2022
Preoperative information ,	Preoperative LMWH aplication Yes No	from december 2021 to september 2022
Preoperative information	Preoperative antibiotic prophylaxis Yes No	from december 2021 to september 2022
Preoperative information	Bowel preparation Yes No	from december 2021 to september 2022
Preoperative information	Skin cleansing with chlorhexidine Yes No	from december 2021 to september 2022
Preoperative information	ASA classification I, II, III	from december 2021 to september 2022
Preoperative information	Solid food restriction period (hour)....hour	from december 2021 to september 2022
Preoperative information	Liquid food restriction period (hour)....hour	from december 2021 to september 2022
Intraoperative applications	Type of anesthesia General, spinal	from december 2021 to september 2022
Intraoperative applications	NG cathetere application yes No	from december 2021 to september 2022
Intraoperative applications	Urinary catheterization application Yes No	from december 2021 to september 2022
Intraoperative applications	Drain application Yes No	from december 2021 to september 2022
Intraoperative applications	Epidural analgesia administration Yes No	from december 2021 to september 2022
Intraoperative applications	Antiemetic agent administration Yes No	from december 2021 to september 2022
Intraoperative applications	Intraoperative IV fluid amount (cc)......cc	from december 2021 to september 2022
Intraoperative applications	Incision length (cm).......cm	from december 2021 to september 2022
Postoperative applications	Nausea Yes No	from december 2021 to september 2022
Postoperative applications	Heating with a heater Yes No	from december 2021 to september 2022
Postoperative applications	Pain score (VAS)1-10	from december 2021 to september 2022
Postoperative applications	Analgesic administration Yes No	from december 2021 to september 2022
Postoperative applications	Type of analgesic ........	from december 2021 to september 2022
Postoperative applications	Posoperative LMWH application Yes No	from december 2021 to september 2022
Postoperative applications	Gum chewing app yes No	from december 2021 to september 2022
Postoperative applications	Status of providing discharge training Yes No	from december 2021 to september 2022
Postoperative applications	Information on control Yes No	from december 2021 to september 2022
Postoperative applications	Principle time breastfeeding (minute).......minute	from december 2021 to september 2022
Postoperative applications	Time to postoperative gas release (hour)........hour	from december 2021 to september 2022
Postoperative applications	Time to postoperative stool output (hour).......hour	from december 2021 to september 2022
Postoperative applications	Time to mobilization (hour)...........hour later	from december 2021 to september 2022
Postoperative applications	Time to urinary catheter removal (hour)..........hour kater	from december 2021 to september 2022
Postoperative applications	Time to oral initiation (hour)........hour	from december 2021 to september 2022
Postoperative applications	Hospitalization time (hour)........hour	from december 2021 to september 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
socio-demographic characteristics.	data on socio-demographic characteristics	from december 2021 to september 2022

Collaborators and Investigators

• Sponsor: Gonca Karatas Baran
• Investigators: Principal Investigator: gonca Karataş Baran, phd, Etlik Zübeyde Hanım Maternity and Women's Health Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Perioperative; Cesarean section; Enhanced recovery after surgery
• Other Study ID Numbers: gkbaran

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No