The Clavien-Dindo classification of surgical complications: five-year experience.
Pierre A Clavien, Jeffrey Barkun, Michelle L de Oliveira...
https://pubmed.ncbi.nlm.nih.gov/19638912Actively Recruiting
Led by University of Cyprus · Updated on 2026-03-31
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
U
University of Cyprus
Lead Sponsor
N
Nicosia General Hospital
Collaborating Sponsor
Emergency laparotomy carries a high risk of complications and death after surgery, especially among older adults who often have reduced physical strength, frailty, and multiple health issues. This trial studies the impact of a structured physiotherapy program after emergency laparotomy in patients aged 65 and older, aiming to improve their recovery and overall clinical outcomes. Participants will be randomly assigned to one of two groups after surgery once they are stable. One group will receive a five-day structured physiotherapy program that includes progressively increasing mobilization, supervised therapeutic exercises, and respiratory training every two hours, supported by a booklet and family involvement. The other group will receive the usual postoperative care, which involves general mobilization and basic breathing instructions without structured progression or monitoring. During the study, participants will have their functional recovery evaluated at hospital discharge and at 30 and 90 days after discharge using validated measures. Additional assessments include handgrip strength, sit-to-stand performance, frailty, nutritional risk, postoperative complications, respiratory complications, hospital length of stay, mortality at 30 days, and quality of life via telephone follow-up. The study monitors adherence through exercise logs and family support, with the total participation lasting through hospital stay and follow-up periods.
CONDITIONS
Physiotherapy After Emergency Laparotomy in the Elderly
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo emergency laparotomy surgery.
1 visit (in-person)
Duration - 5 days
Participants randomized to either a structured five-day postoperative physiotherapy program with progressive mobilization and respiratory exercises, or standard postoperative care with general mobilization and basic breathing instruction.
Daily visits during postoperative hospitalization
Duration - 6 to 15 days postoperatively
Participants remain hospitalized for recovery and undergo assessments including functional status, handgrip strength, sit-to-stand performance, and monitoring of postoperative complications.
Multiple visits during hospitalization
Duration - Up to 90 days after discharge
Participants are followed up to assess functional recovery, health-related quality of life, and mortality at 30 and 90 days after hospital discharge.
2 follow-up visits via telephone at 30 and 90 days after discharge
Total: 1 location
1
Nicosia General Hospital
Nicosia, Cyprus, 2031
Actively Recruiting
P
Polyxeni Michael Vargiamidou, PT
D
Dr. Nikolaos Gouvas, M.D, Ph.D
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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