NCT Number: NCT07504185
Emergency laparotomy is associated with high postoperative morbidity and mortality. This risk is particularly high among elderly patients, who often present with reduced physiological reserve, frailty, and multimorbidity.
The aim of this study is to evaluate the effect of a structured postoperative physiotherapy program in patients aged 65 years and older undergoing emergency laparotomy. The study will assess its impact on functional recovery and clinical outcomes.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Nicosia, 2031, Cyprus
Location status: Recruiting
Dr. Nicolaos Gouvas, Assoc. Professor of Surgery
CONTACT
Polyxeni M Vargiamidou, Physiotherapist
PRINCIPAL_INVESTIGATOR
Polyxeni Michael Vargiamidou, Physiotherapist
CONTACT
This is a multicenter, parallel-group randomized controlled trial evaluating a structured postoperative physiotherapy program in older adults undergoing emergency laparotomy. Participants aged ≥65 years who undergo an index emergency laparotomy will be enrolled at Nicosia General Hospital (Cyprus) and the University Hospital of Heraklion (Greece) and randomized 1:1 to either (a) a standardized, progressive 5-day postoperative physiotherapy package (supervised early mobilization with progressive targets, coached breathing/airway clearance exercises, and supported self-practice with family/caregiver engagement) or (b) usual postoperative care as delivered in routine practice.
Randomization will occur after surgery once the participant is clinically stable on the surgical ward (including after ICU step-down when applicable), using a computer-generated allocation sequence. Functional recovery will be assessed using validated measures at prespecified time points during the index hospitalization and at follow-up (30 and 90 days). Key secondary outcomes include postoperative complications, postoperative pulmonary complications, length of stay, mortality, and health-related quality of life. Analyses will compare groups according to the intention-to-treat principle.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Able to provide informed consent or have a legally authorized representative provide consent.
Able to maintain an upright standing position for at least one minute with minimal or no assistance.
Exclusion criteria
A structured five-day postoperative physiotherapy program including progressively increasing mobilization, supervised therapeutic exercises, and respiratory training every two hours. Participants will receive an exercise booklet and daily log for monitoring adherence.
Other names: Treatment Group
Standard postoperative physiotherapy according to usual hospital practice, including general mobilization and basic breathing instruction without structured progression or monitoring.
Other names: Controll Group
Time frame: At hospital discharge (6-15 days postoperatively on average), and at 30 and 90 days after discharge.
Functional independence measured with the Barthel Index of Activities of Daily Living (ADL), total score 0-100. Higher scores indicate better function/greater independence. Scores will be compared with baseline (preoperative functional level) and reassessed at follow-up (At hospital discharge, and at 30 and 90 days after discharge).
Time frame: At hospital discharge (6-15 days postoperatively on average)
Muscle strength will be assessed using a handgrip dynamometer. The participant will be seated, with the elbow of the dominant hand supported on a stable surface at a 90° angle. The participant will then be instructed to squeeze the dynamometer handle as forcefully as possible.
The test will be repeated three (3) times, and the highest value recorded will be used for analysis. Measurements of <20 kg for women and <30 kg for men will be considered indicative of reduced muscle strength.
Time frame: At hospital discharge (6-15 days postoperatively on average).
Participants attempt to stand from a 47-cm chair without using their arms, completing as many repetitions as possible within 30 seconds. Performance <8 repetitions indicates reduced functional ability.
Time frame: Baseline: within 24 hours of hospital admission (or, if not feasible, within 24 hours of arrival to the surgical ward postoperatively), prior to randomization
Frailty assessed with the 11-item Modified Frailty Index (mFI-11). The score can be reported as a count (0-11) or as a proportion (0.00-1.00) / percentage (0-100%). Higher scores indicate greater frailty and worse prognosis
Time frame: Baseline: within 24 hours of hospital admission (or, if not feasible, within 24 hours of arrival to the surgical ward postoperatively), prior to randomization
Nutritional risk assessed with the Malnutrition Universal Screening Tool (MUST), total score 0-6. Higher scores indicate higher risk of malnutrition (0=low, 1=medium, ≥2=high)
Time frame: From postoperative day 1 through hospital discharge (6-15 days postoperatively average)
A 5-grade classification system used in surgery to standardize the reporting of postoperative complications based on the severity of the intervention required to treat them.
Time frame: From postoperative day 1 through hospital discharge (6-15 days postoperatively average)
The Melbourne Group Scale (MGS) was developed by physiotherapists as an objective tool for the diagnosis of postoperative pulmonary complications (PPCs). It comprises eight standardized clinical criteria, including abnormal breath sounds on auscultation, increased sputum production, fever, hypoxaemia, chest imaging findings consistent with atelectasis or consolidation, elevated white blood cell count, physician diagnosis of pneumonia, and prolonged requirement for high oxygen supplementation.
A postoperative pulmonary complication is diagnosed when four (4) or more of these eight criteria are present within a 24-hour period.
Time frame: From admission to hospital discharge (6-15 days postoperatively average)
Number of days in Hospital
Time frame: 30 Days after discharge
Living stadus in 30 Days after discharge
Time frame: The tool will be used at 30 and 90 days after discharge via telephone follow-up.
The EQ-5D, developed by the EuroQol Group, is a widely validated measure of health-related quality of life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five severity levels, and a visual analogue scale (0-100) for global health. Responses produce a five-digit health state code (e.g., 11111 = best health). A validated Greek version is available.
Contact information is provided by the study sponsor or research team.
Dr. Nikolaos Gouvas, M.D, Ph.D
CONTACT
Polyxeni Michael Vargiamidou, PT
CONTACT
University of Cyprus
Other
Effect of Postoperative Physiotherapy on Postoperative Outcomes of Elderly Patients Undergoing Emergency Laparotomy
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