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| Name | Class |
|---|---|
| Nicosia General Hospital | OTHER |
| University of Crete | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength (dynamometry), | 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. |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Konstantinos G. Lasithiotakis, M.D., Ph.D | Medical School, University of Crete | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicosia General Hospital | Recruiting | Nicosia | 2031 | Cyprus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19638912 | Background | 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. | |
| 3558716 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Book Chapter (Actual Problems of Emergency Abdominal Surgery) | View IPD |
Individual participant data will not be publicly available due to privacy and confidentiality considerations and institutional data protection policies.
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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.
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No other parties are masked
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| Standard postoperative care | Other | Standard postoperative physiotherapy according to usual hospital practice, including general mobilization and basic breathing instruction without structured progression or monitoring. |
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| At hospital discharge (6-15 days postoperatively on average) |
| sit-to-stand performance, | 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), | 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), | 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), | 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) | 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, | Number of days in Hospital | From admission to hospital discharge (6-15 days postoperatively average) |
| 30-day mortality | Living stadus in 30 Days after discharge | 30 Days after discharge |
| health-related quality of life (EQ-5D at 30 and 90 days) | 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. |
| 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. |
| 30181091 | 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. |
| 22695416 | 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. |
| 31987550 | 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. |
| 36597159 | 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. |
| 33119404 | 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. |
| 18489492 | 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. |
| 37877957 | 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. |
| 22309427 | 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. |
| 29988707 | 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. |
| 23060237 | 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. |
| 38902197 | 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. |
| 3454879 | 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. |
| 22917646 | 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. |
| 27502400 | 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. |
| 36109368 | 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. |
| Result | 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. |