Physiotherapy After Emergency Laparotomy in the Elderly

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Functional Status [Time frame: At hospital discharge (6-15 days postoperatively on average), and at 30 and 90 days after discharge.]

Secondary outcome measures (9)

• Handgrip strength (dynamometry), [Time frame: At hospital discharge (6-15 days postoperatively on average)]
• sit-to-stand performance, [Time frame: 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]
• 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]
• postoperative complications (Clavien-Dindo), [Time frame: 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)]
• Hospital length of stay, [Time frame: From admission to hospital discharge (6-15 days postoperatively average)]
• 30-day mortality [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Cyprus · 1 center

• Nicosia General Hospital — Nicosia

Publications

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. PMID 19638912
• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. PMID 3558716
• Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Comp PMID 30181091
• Farhat JS, Velanovich V, Falvo AJ, Horst HM, Swartz A, Patton JH Jr, Rubinfeld IS. Are the frail destined to fail? Frailty index as predictor of surgical morbidity and mortality in the elderly. J Trauma Acute Care Surg. 2012 Jun;72(6):1526-30; discussion 1530-1. doi: 10.1097/TA.0b013e3182542fab. PMID 22695416
• Mehmet H, Yang AWH, Robinson SR. Measurement of hand grip strength in the elderly: A scoping review with recommendations. J Bodyw Mov Ther. 2020 Jan;24(1):235-243. doi: 10.1016/j.jbmt.2019.05.029. Epub 2019 May 24. PMID 31987550
• de Melo TA, Silva Guimaraes F, Lapa E Silva JR. The five times sit-to-stand test: safety, validity and reliability with critical care survivors's at ICU discharge. Arch Physiother. 2022 Dec 18;13(1):2. doi: 10.1186/s40945-022-00156-z. PMID 36597159
• Tafiadis D, Ziavra N, Prentza A, Siafaka V, Zarokanellou V, Voniati L, Konitsiotis S. Validation of the Greek version of the Abbreviated Mental Test Score: Preliminary findings for cognitively impaired patients of different etiology. Appl Neuropsychol Adult. 2022 Sep-Oct;29(5):1003-1014. doi: 10.1080/23279095.2020.1835915. Epub 2020 Oct 29. PMID 33119404
• Kontodimopoulos N, Pappa E, Niakas D, Yfantopoulos J, Dimitrakaki C, Tountas Y. Validity of the EuroQoL (EQ-5D) instrument in a Greek general population. Value Health. 2008 Dec;11(7):1162-9. doi: 10.1111/j.1524-4733.2008.00356.x. Epub 2008 May 16. PMID 18489492

Identifiers

NCT: NCT07504185 · UCY2026-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗