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Not yet recruiting NCT07374380

Nurse-Led Early Mobilization After Colorectal Surgery

No phase Interventional Colorectal Surgery Early Mobilization Postoperative Care Postoperative Recovery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nurse-Led Early Mobilization, Standard Mobilization Care.
Who it may be relevant to
Registry conditions: Colorectal Surgery, Early Mobilization, Postoperative Care, Postoperative Recovery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of a Nurse-Led Early Mobilization Protocol on Colorectal Surgery Patients: A Randomized Controlled Trial

Overview

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.

Interventions

  • Other Nurse-Led Early Mobilization
    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 Activitie
  • Other Standard Mobilization Care
    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.

Primary outcome measures

  • Mobility level assessed [Time frame: between postoperative day 0 and postoperative day 3]
  • Total walking distance (measured by pedometer) [Time frame: between postoperative day 0 and postoperative day 3]
  • 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)]
  • 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)]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Ege University — Izmir

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. PMID 37187102

Identifiers

NCT: NCT07374380 · 25-12T/49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗