Physiotherapy After Emergency Laparotomy in the Elderly
ConditionEmergency Abdominal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Cyprus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥ 65 years
Undergoing emergency laparotomy with or without stoma creation (adhesiolysis, right hemicolectomy, total colectomy, Hartmann's procedure, cholecystectomy, abscess drainage).
Disqualifiers
Patients with Dementia (Abbreviated Mental Test Score < 6)
Pre-existing severe disabilities affecting mobility
Patients with contraindications to physiotherapy (e.g., severe cardiopulmonary instability)
Patients transferred postoperatively from other hospitals
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental (Structured postoperative physiotherapy)
BehavioralA 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.
Standard postoperative care
Other interventionStandard postoperative physiotherapy according to usual hospital practice, including general mobilization and basic breathing instruction without structured progression or monitoring.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Intervention - 5-Day ProtocolExperimental treatment 1 intervention
Group B: Arm 2: Standard careOther 1 intervention
Trial outcomes
Primary outcomes
1
Functional Status
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), and at 30 and 90 days after discharge.Secondary outcomes
1
Handgrip strength (dynamometry),
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)2
sit-to-stand performance,
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
At hospital discharge (6-15 days postoperatively on average).3
frailty (mFI-11),
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 randomization4
nutritional risk (MUST),
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
Baseline: within 24 hours of hospital admission (or, if not feasible, within 24 hours of arrival to the surgical ward postoperatively), prior to randomizationSponsors and contacts
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Source ClinicalTrials.gov