Physiotherapy After Emergency Laparotomy in the Elderly

NCT07504185 | Recruiting

• 1 other identifier: UCY2026-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergency Abdominal Surgery

Keywords

postoperative recovery, elderly, emergency abdominal surgery; Physiotherapy intervention

Outcome Measures

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).

  At hospital discharge (6-15 days postoperatively on average), and at 30 and 90 days after discharge.

Secondary Outcomes (9)

• Handgrip strength (dynamometry),

  At hospital discharge (6-15 days postoperatively on average)

• sit-to-stand performance,

  At hospital discharge (6-15 days postoperatively on average).

• frailty (mFI-11),

  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),

  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),

  From postoperative day 1 through hospital discharge (6-15 days postoperatively average)

Study Arms (2)

Arm 1: Intervention - 5-Day Protocol

EXPERIMENTAL

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)

Arm 2: Standard care

OTHER

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

Interventions

Experimental (Structured postoperative physiotherapy) BEHAVIORAL

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.

Also known as: Treatment Group

Arm 1: Intervention - 5-Day Protocol

Standard postoperative care OTHER

Standard postoperative physiotherapy according to usual hospital practice, including general mobilization and basic breathing instruction without structured progression or monitoring.

Also known as: Controll Group

Arm 2: Standard care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cyprus: lead
• Nicosia General Hospital: collaborator
• University of Crete: collaborator

Study Sites (1)

Nicosia General Hospital

Nicosia, 2031, Cyprus

RECRUITING

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.

  PMID: 30181091 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Ferfeli S, Galanos A, Dontas IA, Triantafyllou A, Triantafyllopoulos IK, Chronopoulos E. Reliability and validity of the Greek adaptation of the Modified Barthel Index in neurorehabilitation patients. Eur J Phys Rehabil Med. 2024 Feb;60(1):44-54. doi: 10.23736/S1973-9087.23.08056-5. Epub 2023 Oct 25.

  PMID: 37877957 BACKGROUND

• Hanekom SD, Brooks D, Denehy L, Fagevik-Olsen M, Hardcastle TC, Manie S, Louw Q. Reaching consensus on the physiotherapeutic management of patients following upper abdominal surgery: a pragmatic approach to interpret equivocal evidence. BMC Med Inform Decis Mak. 2012 Feb 6;12:5. doi: 10.1186/1472-6947-12-5.

  PMID: 22309427 BACKGROUND

• Boden I, Sullivan K, Hackett C, Winzer B, Lane R, McKinnon M, Robertson I. ICEAGE (Incidence of Complications following Emergency Abdominal surgery: Get Exercising): study protocol of a pragmatic, multicentre, randomised controlled trial testing physiotherapy for the prevention of complications and improved physical recovery after emergency abdominal surgery. World J Emerg Surg. 2018 Jul 3;13:29. doi: 10.1186/s13017-018-0189-y. eCollection 2018.

  PMID: 29988707 BACKGROUND

• Grams ST, Ono LM, Noronha MA, Schivinski CI, Paulin E. Breathing exercises in upper abdominal surgery: a systematic review and meta-analysis. Rev Bras Fisioter. 2012 Sep-Oct;16(5):345-53. doi: 10.1590/s1413-35552012005000052. Epub 2012 Oct 9.

  PMID: 23060237 BACKGROUND

• Boden I. Physiotherapy management of major abdominal surgery. J Physiother. 2024 Jul;70(3):170-180. doi: 10.1016/j.jphys.2024.06.005. Epub 2024 Jun 19. No abstract available.

  PMID: 38902197 BACKGROUND

• Wender M, Godlewski A, Szczech J. Oligodendroglia of the ageing human brain. Karyometric and cytophotometric studies. Neuropatol Pol. 1987;25(4):461-72. No abstract available.

  PMID: 3454879 BACKGROUND

• Chow WB, Rosenthal RA, Merkow RP, Ko CY, Esnaola NF; American College of Surgeons National Surgical Quality Improvement Program; American Geriatrics Society. Optimal preoperative assessment of the geriatric surgical patient: a best practices guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society. J Am Coll Surg. 2012 Oct;215(4):453-66. doi: 10.1016/j.jamcollsurg.2012.06.017. Epub 2012 Aug 21. No abstract available.

  PMID: 22917646 BACKGROUND

• Tolstrup MB, Watt SK, Gogenur I. Morbidity and mortality rates after emergency abdominal surgery: an analysis of 4346 patients scheduled for emergency laparotomy or laparoscopy. Langenbecks Arch Surg. 2017 Jun;402(4):615-623. doi: 10.1007/s00423-016-1493-1. Epub 2016 Aug 9.

  PMID: 27502400 BACKGROUND

• Lasithiotakis K, Kritsotakis EI, Kokkinakis S, Petra G, Paterakis K, Karali GA, Malikides V, Anastasiadis CS, Zoras O, Drakos N, Kehagias I, Kehagias D, Gouvas N, Kokkinos G, Pozotou I, Papatheodorou P, Frantzeskou K, Schizas D, Syllaios A, Palios IM, Nastos K, Perdikaris M, Michalopoulos NV, Margaris I, Lolis E, Dimopoulou G, Panagiotou D, Nikolaou V, Glantzounis GK, Pappas-Gogos G, Tepelenis K, Zacharioudakis G, Tsaramanidis S, Patsarikas I, Stylianidis G, Giannos G, Karanikas M, Kofina K, Markou M, Chrysos E. The Hellenic Emergency Laparotomy Study (HELAS): A Prospective Multicentre Study on the Outcomes of Emergency Laparotomy in Greece. World J Surg. 2023 Jan;47(1):130-139. doi: 10.1007/s00268-022-06723-6. Epub 2022 Sep 15.

  PMID: 36109368 BACKGROUND

• Kabir MF, Jahan S, Hossain MZ, Chakrovorty SK, Sarker AH, Hossain MA, et al. Effect of chest physiotherapy along with early mobility after abdominal surgery. European Journal of Medical and Health Sciences. 2021 Feb 9;3(1):150-6.

  RESULT

Study Officials

• Konstantinos G. Lasithiotakis, M.D., Ph.D

  Medical School, University of Crete

  STUDY DIRECTOR

Central Study Contacts

Polyxeni Michael Vargiamidou, PT

CONTACT

+35799476613; michael-vargiamidou.p@ucy.ac.cy

Dr. Nikolaos Gouvas, M.D, Ph.D

CONTACT

+35799821132; gouvas.nikolaos@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No other parties are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-blind study conducted at the General Surgery Clinics A and B of Nicosia General Hospital including patients aged ≥65 years undergoing emergency laparotomy. Participants will be randomly assigned in parallel to two groups. The intervention group will receive a structured five-day postoperative physiotherapy program with progressively increasing mobilization, exercises, and respiratory training, while the control group will receive standard postoperative care with basic instruction in respiratory exercises only.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 31, 2026
• Study Start: July 13, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)