Tests an accelerated recovery protocol after lung surgery in adults
Tests a faster recovery plan after lung removal surgery in adults with lung cancer.
Plain-language title generated from the registry record
Registry title: Protocol for Accelerated Recovery in Patients Undergoing Thoracic Surgical Procedures (PROSM). Study Randomized Comparative Between the Adoption of the Proposed Guidelines and the Traditional Method Currently Used in the Institution
Key facts
- Where
- São Paulo, BrazilSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who will have planned lung surgery to treat a lung tumour. It compares a faster-recovery care plan with the usual care at the hospital.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Planned (elective) removal of lung tissue (segmentectomy, lobectomy or pneumonectomy) to treat a neoplastic (tumour) lung disease.
Main reasons for not taking part
- Cannot read, understand and sign the informed consent
- ECOG performance status greater than 2
- Body mass below 60 kg (132 lb) or greater than 120 kg (265 lb)
- Allergy to latex or to any of the anaesthesia drugs used in the plan
- Kidney dysfunction, liver dysfunction or severe heart failure
Read by machine on 12 November 2026.
Where in Brazil
- Ambulatório de Nódulos e Massas Pulmonares H Santa MarcelinaSão Paulo, BrazilContact: Igor Renato LB Abreu, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Igor Renato Louro Bruno de Abreu
- Trial code
- NCT03271749
- Record updated
- 21 December 2020
- Original description
Introduction:Read full original descriptionShow less
Protocol for Accelerated Recovery in Patients Undergoing Thoracic Surgical Procedures Adapted to the Conditions of Santa Marcelina - Itaquera Hospital - São Paulo - Brazil (PROSM). Study Randomized Comparative Between the Adoption of the Proposed Guidelines and the Traditional Method Currently Used in the Institution
Introduction:
Aiming at reducing costs and optimizing the use of these financial resources, several postoperative recovery protocols have emerged that aim to reduce the length of hospital stay by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic scenario allied to the existing scientific knowledge on the subject , the investigators developed a protocol that aims to meet this need using resources already available and offered in brazilian public health system. The investigators called this protocol as Protocol of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of accelerated postoperative recovery already used in several European health services.
Goals:
1. To evaluate the impact of PROSM on the length of hospitalization in days and postoperative pain (visual analog pain scale - VAS) in patients submitted to surgical procedures performed by the thoracic surgery team of the Hospital Santa Marcelina de Itaquera. 2. Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment and hospitalization of these patients.
Materials and methods:
A group of 200 patients with elective pulmonary resections (segmentectomies, lobectomies or pneumonectomies) to treat neoplastic lung diseases will be selected by the investigators.
The participants will be randomized into two groups (rate of randomization 1/1).
The first group will be submitted to the standard surgical treatment that is currently used in Santa Marcelina - Itaquera hospital. The second group will be submitted to treatment with the adoption of the PROSM guidelines, which will be detailed later.
Investigators will evaluate in the two groups: surgical time in minutes, intraoperative complications: intraoperative bleeding in mililiters, need for transfusion of blood products, intraoperative clinical complications. Investigators will also evaluate the need for postoperative recovery in Intensive Care Unit (ICU), medications used to maintain the anesthetic plane during the procedure (amount of drugs in milligrams), medications used for postoperative analgesia, length of hospital stay in days, postoperative clinical complications, need for surgical re-boarding, immediate postoperative pain (VAS), postoperative pain at the time of discharge and the first outpatient return (VAS), the need for opioid analgesics at home after discharge.
After the data collection, the investigators will analyze them and make a comparative study of the costs of surgical treatment and hospitalization between the two groups. This data will be obtained from the billing department of the Hospital Santa Marcelina de Itaquera.
Inclusion: patients with elective pulmonary resections (segmentectomies, lobectomies or pneumonectomies) to treat neoplastic lung diseases.
Exclusion: allergy to latex; patients with a history of allergy to any of the drugs used in anesthesia for PROSM; severe cardiac dysfunction (cardiac failure); unable to read, understand and sign informed consent; patients with compromised performance status (ECOG greater than 2); body mass below 60 kg or greater than 120 kg; patients with renal dysfunction; liver dysfunction.