Evaluation of Early Mobilization Protocol in Patients Undergoing Gastrointestinal Surgery

November 11, 2024 updated by: Derya Şayır Koksal, Uludag University

Evaluation of the Early Mobilization Protocol Established in Accordance With Enhanced Recovery After Surgery Guidelines in Patients Undergoing Gastrointestinal Surgery

In this study, the investigators aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is an experimental study. The participants in the control group are applied to the mobilization applied in routine clinics. The participants in the intervention group are applied to the mobilization protocol created in accordance with the Enhanced Recovery After Surgery (ERAS) guidelines. It is planned to evaluate the postoperative mobilization process of both groups.

In this study, the researchers aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kütahya, Turkey, 43100
        • Derya Şayır Köksal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being 18 years of age or older
  • Agreeing to participate in the study
  • Being able to understand, speak Turkish or have no obstacle to communication
  • Having undergone open gastrointestinal surgery
  • Having an American Society of Anesthesiologists (ASA) score <IV
  • Being fully independent according to the Modified Barthel Index during the pre-operative period
  • Staying in the hospital for at least 48 hours after the surgery
  • Having a phone
  • Agreeing to download the 'StepsApp Pedometer' application to their phone
  • Agreeing to carry the phone with them during the post-operative mobilization processes

Exclusion Criteria:

  • Being taken into emergency surgery
  • Having had major gastrointestinal surgery before
  • Having a diagnosis that may restrict mobilization (neurological, cardiovascular, respiratory and musculoskeletal comorbidities)
  • High risk of falling in the preoperative period
  • Using medication that may affect mobilization
  • Having a diagnosis of any psychiatric disease
  • Having a Nutritional Risk Score score of ≥3
  • Being in contact isolation
  • Being morbidly obese
  • Being in intensive care for more than 24 hours during the postoperative period
  • Having an intubation period of more than 24 hours during the postoperative period
  • Developing a complication that may prevent mobilization after surgery
  • Withdrawing from participating in the study,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Mobilization Performed in Routine Clinic Group
Participants undergoing gastrointestinal surgery will receive routine clinic mobilization. The investigator will not perform any interventions.
Experimental: Early Mobilization Protocol Created in Enhanced Recovery After Surgery (ERAS) Guidelines Group

Participants undergoing gastrointestinal surgery will watch a video 1 day before surgery that includes information about the importance of mobilization and the process.

The participant will be applied a mobilization protocol created in line with the postoperative mobilization eras (enhanced recovery after surgery) guidelines.
Procedure: Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol
The intervention is applied from the first day after surgery until discharge. (including the day of discharge).
Other Names:
  • Early Mobilization Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the number of steps taken daily after surgery
Time Frame: From admission to discharge, up to 1 week
The number of steps taken by the participant daily after surgery will be measured via a phone pedometer application (StepsApp).
From admission to discharge, up to 1 week
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the distance moved after surgery
Time Frame: From admission to discharge, up to 1 week
The daily distance moved by the participant after surgery will be measured via a phone pedometer application (StepsApp).
From admission to discharge, up to 1 week
The effect of the ERAS early mobilization protocol on the recovery of the gastrointestinal system after surgery
Time Frame: From admission to discharge, up to 1 week
The researcher will record the day the participant first passed gas after surgery and the date of his/her first defecation.
From admission to discharge, up to 1 week
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the level of ability to perform daily living activities after surgery
Time Frame: (From admission to discharge, up to 1 week) and (When he comes for a check-up 1 week after discharge)
The researcher makes the measurement with the Modified Barthel Index scale. Modified Barthel Index: The highest score is 100, the lowest score is 0. The patient is stated as fully dependent in the range of 0-20 points, highly dependent in the range of 21-61 points, moderately dependent in the range of 62-90 points, slightly dependent in the range of 91-99 points, and fully independent in the range of 100 points. Daily evaluations are made until discharge after surgery.
(From admission to discharge, up to 1 week) and (When he comes for a check-up 1 week after discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Principal Investigator: Derya Şayır Köksal, Lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 9, 2025

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UludagU-SBF-DSK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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