Physiotherapy After Emergency Laparotomy in the Elderly

University of Cyprus

Status: Enrolling

Conditions: Emergency Abdominal Surgery

Treatments: Other: Standard postoperative care; Behavioral: Experimental (Structured postoperative physiotherapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT07504185

UCY2026-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥ 65 years
• Undergoing emergency laparotomy with or without stoma creation (adhesiolysis, right hemicolectomy, total colectomy, Hartmann's procedure, cholecystectomy, abscess drainage).

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

• 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
• Patients who underwent no intervention during laparotomy (negative laparotomies)
• Patients undergoing palliative procedures and at the end of life

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Arm 1: Intervention - 5-Day Protocol

Experimental group

Description:

Participants will receive a structured five-day postoperative physiotherapy program including progressively increasing mobilization, supervised therapeutic exercises, and respiratory training every two hours. A booklet with detailed exercise instructions and a daily log for recording repetitions will be provided. A family member will be informed to support adherence. Nutritional risk will be assessed and its association with functional recovery will be evaluated

Treatment:

Behavioral: Experimental (Structured postoperative physiotherapy)

Arm 2: Standard care

Other group

Description:

Participants in the control group will receive standard postoperative physiotherapy according to usual hospital practice. This includes general mobilization without a structured or progressively increasing protocol. Instruction in deep breathing exercises and voluntary coughing will be provided only once on the first postoperative day, without further supervision or reinforcement. No lower limb strengthening or muscle pump exercises will be implemented, and no exercise booklet, daily monitoring, or structured adherence tracking will be provided.

Treatment:

Other: Standard postoperative care