Trials / Recruiting
RecruitingNCT07504185
Physiotherapy After Emergency Laparotomy in the Elderly
Effect of Postoperative Physiotherapy on Postoperative Outcomes of Elderly Patients Undergoing Emergency Laparotomy
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- University of Cyprus · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Experimental (Structured postoperative physiotherapy) | 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 | Standard postoperative care | Standard postoperative physiotherapy according to usual hospital practice, including general mobilization and basic breathing instruction without structured progression or monitoring. |
Timeline
- Start date
- 2025-07-13
- Primary completion
- 2027-12-31
- Completion
- 2028-05-31
- First posted
- 2026-03-31
- Last updated
- 2026-03-31
Locations
1 site across 1 country: Cyprus
Source: ClinicalTrials.gov record NCT07504185. Inclusion in this directory is not an endorsement.