Colorectal SurgeryNCT07374380
Nurse-Led Early Mobilization After Colorectal Surgery
A study testing Nurse-Led Early Mobilization and Standard Mobilization Care in people with Colorectal Surgery and Early Mobilization, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Early Mobilization, Postoperative Care
- What is being tested?
- Nurse-Led Early Mobilization and Standard Mobilization Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 29 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meryem Yavuz van Giersbergen contact
About this study
Official title: Effect of a Nurse-Led Early Mobilization Protocol on Colorectal Surgery Patients: A Randomized Controlled Trial
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?
Read the detailed description
Colorectal surgery is a commonly performed procedure in general surgery clinics and requires intensive postoperative nursing care. Despite advances in surgical techniques, postoperative complications such as anastomotic leakage, wound infection, paralytic ileus, and pulmonary complications remain significant challenges in patients undergoing colorectal surgery.
Enhanced Recovery After Surgery (ERAS) protocols have been developed to reduce the metabolic impact of surgical stress, accelerate recovery, and decrease postoperative complications. Early mobilization is a key component of ERAS pathways and is strongly recommended within the first 24 hours following elective colorectal surgery. Early mobilization has been shown to improve gastrointestinal function, reduce postoperative fatigue, shorten hospital length of stay, and enhance overall recovery.
However, the implementation of early mobilization in routine clinical practice is often inconsistent. Institutional constraints, patient-related physical and psychological barriers, lack of knowledge, and negative beliefs regarding mobilization may delay postoperative activity, particularly in patients undergoing colorectal surgery.
Nurses play a central role in postoperative care and are well positioned to lead, coordinate, and monitor early mobilization activities. Nurse-led, structured mobilization protocols may facilitate early mobilization by providing systematic patient education, clear activity goals, and continuous monitoring during the postoperative period.
Although nurse-led mobilization protocols have been evaluated in limited randomized controlled trials across various surgical populations, evidence specifically focused on patients undergoing colorectal surgery remains scarce.
This randomized controlled trial aims to evaluate the effectiveness of a nurse-led early mobilization protocol compared with standard mobilization practices in patients undergoing elective colorectal surgery. The study focuses on postoperative recovery outcomes, including mobility, gastrointestinal function, patient comfort, fatigue, postoperative complications, patient satisfaction, and length of hospital stay. The findings of this study are expected to provide evidence to support the integration of nurse-led early mobilization protocols into routine colorectal surgical care.
- Being tested
- Nurse-Led Early Mobilization, Standard Mobilization Care
- Keywords
- colorectal surgery, early mobilization, Nurse-Led Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Early MobilizationOther
- 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.
- 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
Standard Mobilization CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Mobilization Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Postoperative nausea and vomiting will be assessed based on patient self-report and will be recorded by the researcher as a binary outcome (presence or absence) without using a standardized scale during the first three postoperative days.
Measured: during the first 3 postoperative days
Fatigue level
Modified Borg Scale Fatigue was assessed using the Modified Borg Scale, an 11-point scale ranging from 0 (no fatigue) to 10 (very, very hard). Patients' fatigue levels were evaluated on postoperative days 0, 1, 2, and 3.
Measured: researcher during the first 3 postoperative days
Comfort level
The Visual Analog Scale (VAS) is a valid, reliable, and practical measurement tool widely used to quantify subjective experiences that cannot be directly measured numerically. In this study, patient satisfaction will be assessed using the VAS (0-10). Higher VAS scores indicate greater levels of comfort.
Measured: Patients will be assessed on postoperative days 0, 1, 2, and 3.
Patient satisfaction
The Visual Analog Scale (VAS) is a valid, reliable, and practical measurement tool widely used to quantify subjective experiences that cannot be directly measured numerically. In this study, patient satisfaction will be assessed using the VAS (0-10). Scores ranged from 0 (low satisfaction) to 10 (high satisfaction)
Measured: on postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nebihat Tekin, Ege University
- Investigators
- Meryem N., Yavuz van Giersbergen, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374380
- Sponsor's protocol ID
- 25-12T/49
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie J, Luo C, Du Q, Zou W, Li X, Ma Z, Wu X, Zhang M. Factors associated with early mobilization among colorectal cancer patients after surgery: A cross-sectional study. Eur J Oncol Nurs. 2023 Jun;64:102317. doi: 10.1016/j.ejon.2023.102317. Epub 2023 Apr 7. No abstract available.
PubMed 37187102
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nurse-Led Early Mobilization Protocol on Colorectal Surgery Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07374380
- Acronym / sponsor ID
- 25-12T/49
- Keywords
- colorectal surgery, early mobilization, Nurse-Led Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Colorectal surgery is a commonly performed procedure in general surgery clinics and requires intensive postoperative nursing care. Despite advances in surgical techniques, postoperative complications such as anastomotic leakage, wound infection, paralytic ileus, and pulmonary complications remain significant challenges in patients undergoing colorectal surgery.
Enhanced Recovery After Surgery (ERAS) protocols have been developed to reduce the metabolic impact of surgical stress, accelerate recovery, and decrease postoperative complications. Early mobilization is a key component of ERAS pathways and is strongly recommended within the first 24 hours following elective colorectal surgery. Early mobilization has been shown to improve gastrointestinal function, reduce postoperative fatigue, shorten hospital length of stay, and enhance overall recovery.
However, the implementation of early mobilization in routine clinical practice is often inconsistent. Institutional constraints, patient-related physical and psychological barriers, lack of knowledge, and negative beliefs regarding mobilization may delay postoperative activity, particularly in patients undergoing colorectal surgery.
Nurses play a central role in postoperative care and are well positioned to lead, coordinate, and monitor early mobilization activities. Nurse-led, structured mobilization protocols may facilitate early mobilization by providing systematic patient education, clear activity goals, and continuous monitoring during the postoperative period.
Although nurse-led mobilization protocols have been evaluated in limited randomized controlled trials across various surgical populations, evidence specifically focused on patients undergoing colorectal surgery remains scarce.
This randomized controlled trial aims to evaluate the effectiveness of a nurse-led early mobilization protocol compared with standard mobilization practices in patients undergoing elective colorectal surgery. The study focuses on postoperative recovery outcomes, including mobility, gastrointestinal function, patient comfort, fatigue, postoperative complications, patient satisfaction, and length of hospital stay. The findings of this study are expected to provide evidence to support the integration of nurse-led early mobilization protocols into routine colorectal surgical care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Early Mobilization Protocol | Experimental | Other: Nurse-Led Early MobilizationParticipants 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. |
| Standard Mobilization Care | Active comparator | Other: Standard Mobilization CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Early Mobilization1. 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 | Other | Nurse-Led Early Mobilization Protocol |
| Standard Mobilization CareParticipants 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 |
Primary outcome
Mobility level assessed
Time frame: between postoperative day 0 and postoperative day 3
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.
Total walking distance (measured by pedometer)
Time frame: between postoperative day 0 and postoperative day 3
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.
Time to first flatus (hours postoperatively)
Time frame: From the end of surgery until the patient-reported first postoperative passage of flatus (within the first 72 hours postoperatively)
The time interval (in hours) from the end of surgery to the first passage of flatus reported by the patient.
Time to first defecation (hours postoperatively)
Time frame: From the end of surgery until the patient-reported first postoperative passage of defecation (within the first 72 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.
4 secondary outcomes
Postoperative nausea and vomiting (PONV)
Time frame: during the first 3 postoperative days
Fatigue level
Time frame: researcher during the first 3 postoperative days
Comfort level
Time frame: Patients will be assessed on postoperative days 0, 1, 2, and 3.
Patient satisfaction
Time frame: on postoperative day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 37187102Xie J, Luo C, Du Q, Zou W, Li X, Ma Z, Wu X, Zhang M. Factors associated with early mobilization among colorectal cancer patients after surgery: A cross-sectional study. Eur J Oncol Nurs. 2023 Jun;64:102317. doi: 10.1016/j.ejon.2023.102317. Epub 2023 Apr 7. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Colorectal Surgery
Not yet recruiting
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meryem Yavuz van Giersbergen contact
Meryem N., Yavuz van Giersbergen study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Early Mobilization and Standard Mobilization Care in people with Colorectal Surgery and Early Mobilization, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nebihat Tekin (+90 539 748 35 91, tekinebihat94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility level assessed (time frame: between postoperative day 0 and postoperative day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.