Physiotherapy After Emergency Laparotomy in the Elderly

March 25, 2026 updated by: Polyxeni Michael Vargiamidou, University of Cyprus

Effect of Postoperative Physiotherapy on Postoperative Outcomes of Elderly Patients Undergoing Emergency Laparotomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 2031
        • Recruiting
        • Nicosia General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Polyxeni M Vargiamidou, Physiotherapist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Intervention - 5-Day Protocol
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
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 Names:
  • Treatment Group
Other: Arm 2: Standard care
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.
Other: Standard postoperative care
Standard postoperative physiotherapy according to usual hospital practice, including general mobilization and basic breathing instruction without structured progression or monitoring.
Other Names:
  • Controll Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Status
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).
At hospital discharge (6-15 days postoperatively on average), and at 30 and 90 days after discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength (dynamometry),
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.
At hospital discharge (6-15 days postoperatively on average)
sit-to-stand performance,
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.
At hospital discharge (6-15 days postoperatively on average).
frailty (mFI-11),
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
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 (MUST),
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)
Baseline: within 24 hours of hospital admission (or, if not feasible, within 24 hours of arrival to the surgical ward postoperatively), prior to randomization
postoperative complications (Clavien-Dindo),
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.
From postoperative day 1 through hospital discharge (6-15 days postoperatively average)
Respiratory complications (Melbourne Score)
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.
From postoperative day 1 through hospital discharge (6-15 days postoperatively average)
Hospital length of stay,
Time Frame: From admission to hospital discharge (6-15 days postoperatively average)
Number of days in Hospital
From admission to hospital discharge (6-15 days postoperatively average)
30-day mortality
Time Frame: 30 Days after discharge
Living stadus in 30 Days after discharge
30 Days after discharge
health-related quality of life (EQ-5D at 30 and 90 days)
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.
The tool will be used at 30 and 90 days after discharge via telephone follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cyprus

Collaborators

University of Crete
Nicosia General Hospital

Investigators

  • Study Director: Konstantinos G. Lasithiotakis, M.D., Ph.D, Medical School, University of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCY2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly available due to privacy and confidentiality considerations and institutional data protection policies.

Study Data/Documents

  1. Book Chapter (Actual Problems of Emergency Abdominal Surgery)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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