Evaluation of Early Mobilization Protocol in Patients Undergoing Gastrointestinal Surgery

NCT06679478 | Enrolling By Invitation

• 1 other identifier: UludagU-SBF-DSK-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Diseases

Keywords

Gastrointestinal Diseases; Enhanced Recovery After Surgery; Early Ambulation

Outcome Measures

Primary Outcomes (4)

• The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the number of steps taken daily after surgery

  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

  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

  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

  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)

Study Arms (2)

Mobilization Performed in Routine Clinic Group

NO INTERVENTION

Participants undergoing gastrointestinal surgery will receive routine clinic mobilization. The investigator will not perform any interventions.

Early Mobilization Protocol Created in Enhanced Recovery After Surgery (ERAS) Guidelines Group

EXPERIMENTAL

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

Interventions

Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol PROCEDURE

The intervention is applied from the first day after surgery until discharge. (including the day of discharge).

Also known as: Early Mobilization Protocol

Early Mobilization Protocol Created in Enhanced Recovery After Surgery (ERAS) Guidelines Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Derya Şayır Köksal

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Derya Şayır Köksal, Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are not informed of which group they are in. The investigators will not inform the person performing the statistical analysis which group the collected data belongs to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: The participants in the control group are given the mobilization applied in routine clinics. The participants in the intervention group are given the mobilization protocol created in accordance with the enhanced recovery after surgery guidelines.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: November 11, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 9, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)