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Enrolling by invitationNCT06679478Updated Nov 13, 2024

Evaluation of Early Mobilization Protocol in Patients Undergoing Gastrointestinal Surgery

An interventional study of Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol in Gastrointestinal Diseases, sponsored by Uludag University. Enrolling by invitation at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by Uludag University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Gastrointestinal Diseases

Keywords

  • Gastrointestinal Diseases
  • Enhanced Recovery After Surgery
  • Early Ambulation
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In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Uludag University is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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,
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureEnhanced Recovery After Surgery (ERAS) Early Mobilization Protocol

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

    Also known as: Early Mobilization Protocol

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: From admission to discharge, up to 1 week

  2. 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).

    Time frame: From admission to discharge, up to 1 week

  3. 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.

    Time frame: From admission to discharge, up to 1 week

  4. 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.

    Time frame: (From admission to discharge, up to 1 week) and (When he comes for a check-up 1 week after discharge)

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Study locations

1 site
  • Derya Şayır Köksal
    Kütahya, 43100, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06679478
Lead sponsor
Uludag University
Responsible party
Derya Şayır Koksal (lecturer, Uludag University) — Principal investigator
First posted
Nov 7, 2024
Start date
Nov 11, 2024
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 9, 2025 (estimated)
Last update
Nov 13, 2024

Study contacts

Derya Şayır Köksal, Lecturer
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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