Nurse-Led Early Mobilization After Colorectal Surgery

NCT07374380 | Not Yet Recruiting

• 1 other identifier: 25-12T/49
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the effectiveness of a nurse-led early mobilization protocol on postoperative recovery outcomes in patients undergoing elective colorectal surgery. The outcomes assessed include walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, incidence of postoperative complications, and length of hospital stay. Research Question: In patients undergoing colorectal surgery (P), does a nurse-led early mobilization protocol (I), compared with standard mobilization practices (C), improve postoperative recovery outcomes (O), including walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, postoperative complication rates, and length of hospital stay?

Conditions

Colorectal Surgery; Early Mobilization; Postoperative Care; Postoperative Recovery

Keywords

colorectal surgery; early mobilization; Nurse-Led Intervention

Outcome Measures

Primary Outcomes (4)

• Mobility level assessed

  Patient-reported / Observer-rated Mobility Scale The Patient Mobility Scale is used to assess pain and perceived exertion experienced during the postoperative period while performing four activities: turning from one side to the other in bed, sitting at the bedside, standing up at the bedside, and walking in the patient's room. Permission to use the scale was obtained from the responsible authors. The Observer Mobility Scale evaluates the degree of patient dependence/independence during mobilization activities. Blood pressure, heart rate, and respiratory rate are measured by the observer two minutes before and after mobilization. Furthermore, the Patient- and Observer-rated Mobility Scales will be administered on postoperative days 1, 2, and 3, and the results will be documented in the monitoring form.

  between postoperative day 0 and postoperative day 3

• Total walking distance (measured by pedometer)

  Mobilization will be monitored using the Mobilization Monitoring Form and step counts obtained from the pedometer will be recorded at the end of each day.

  between postoperative day 0 and postoperative day 3

• Time to first flatus (hours postoperatively)

  The time interval (in hours) from the end of surgery to the first passage of flatus reported by the patient.

  From the end of surgery until the patient-reported first postoperative passage of flatus (within the first 72 hours postoperatively)

• Time to first defecation (hours postoperatively)

  The time interval (in hours) from the end of surgery to the patient's first defecation will be determined and recorded based on patient self-report.

  From the end of surgery until the patient-reported first postoperative passage of defecation (within the first 72 hours postoperatively)

Secondary Outcomes (4)

• Postoperative nausea and vomiting (PONV)

  during the first 3 postoperative days

• Fatigue level

  researcher during the first 3 postoperative days

• Comfort level

  Patients will be assessed on postoperative days 0, 1, 2, and 3.

• Patient satisfaction

  on postoperative day 3

Study Arms (2)

Nurse-Led Early Mobilization Protocol

EXPERIMENTAL

Participants in the intervention group will receive a structured nurse-led early mobilization protocol, developed in accordance with evidence-based guidelines and current literature, in addition to standard postoperative care. As part of the protocol, patients will receive preoperative education regarding the purpose, benefits, and process of early mobilization, along with a postoperative mobilization brochure. In the postoperative period, mobilization will be initiated within the first 6-8 hours in clinically stable patients under nurse supervision. Mobilization activities will progress gradually, including in-bed exercises, sitting, assisted standing, and walking, with daily walking targets increased on postoperative days 0.-3. All mobilization activities will be delivered by nurses and documented using a standardized mobilization monitoring chart.

Other: Nurse-Led Early Mobilization

Standard Mobilization Care

ACTIVE COMPARATOR

Participants in the control group will receive standard postoperative mobilization care routinely provided in the institution. Mobilization activities will be performed according to existing clinical practices, and no structured or protocol-based nurse-led early mobilization program will be implemented. Participants in the control group will continue to receive usual nursing care without any disadvantage or additional risk in terms of patient care.

Other: Standard Mobilization Care

Interventions

Nurse-Led Early Mobilization OTHER

1. Preoperative Period Patients will receive verbal education regarding the purpose, benefits, and process of early mobilization. To support this education, a Postoperative Mobilization Information Brochure prepared by the researchers will be provided to the patient and their caregiver. 2. Postoperative Day 0 Within the first 6-8 hours after surgery, vital signs will be monitored, and mobilization will be initiated in clinically stable patients under nurse supervision. 2.1. In-Bed Activities (Postoperative Hour 5) The following lower-extremity exercises will be performed: Ankle dorsiflexion and plantar flexion Toe movements Leg extension without knee flexion Circular foot movements Each exercise will be performed 5-10 repetitions. The patient will then be positioned in an upright sitting position in bed. 2.2. First Standing and Ambulation (Postoperative Hours 6-8) Vital signs will be assessed. The patient will be assisted to sit at the bedside for 1-2 minutes under nurse

Nurse-Led Early Mobilization Protocol

Standard Mobilization Care OTHER

Participants in the control group will receive standard postoperative mobilization care routinely provided in the institution. Mobilization activities will be performed according to existing clinical practices, and no structured or protocol-based nurse-led early mobilization program will be implemented. Participants in the control group will continue to receive usual nursing care without any disadvantage or additional risk in terms of patient care.

Standard Mobilization Care

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and older
• Scheduled for elective colorectal surgery (e.g., procedures related to
• colorectal cancer, diverticulitis, or inflammatory bowel disease \[IBD\])
• Able to ambulate independently preoperatively
• Medically and cognitively able to participate in a mobilization protocol
• Able to provide written informed consent

You may not qualify if:

• Undergoing emergency colorectal surgery
• Patients requiring postoperative intensive care unit (ICU) admission
• Severe cognitive impairment or psychiatric disorders that may affect participation
• Musculoskeletal or neurological conditions that impair mobility
• Inability to understand study instructions due to language or communication barriers

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

• Xie, J., Luo, C., Du, Q., Zou, W., Li, X., Ma, Z., Wu, X., & Zhang, M. (2023). Factors associated with early mobilization among colorectal cancer patients after surgery: A cross-sectional study. European Journal of Oncology Nursing, 64. https://doi.org/10.1016/j.ejon.2023.102317

  BACKGROUND

Study Officials

• Meryem N., Yavuz van Giersbergen

  Ege University

  STUDY DIRECTOR

Central Study Contacts

Nebihat Tekin

CONTACT

+90 539 748 35 91; tekinebihat94@gmail.com

Meryem Yavuz van Giersbergen

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and care providers is not feasible; however, data analysis will be performed by a statistician blinded to group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse, RN

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 28, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)