Sign in

NCT03271749Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 21 Dec 2020 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
29 Aug 2017
Start date
1 Jul 2021
Primary completion date
1 Dec 2025
Lead sponsor
Igor Renato Louro Bruno de Abreu
Diseases
Lung cancer
NCT number
NCT03271749

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 Jul 2021 to the primary completion date, 1 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • allergy to latex
  • patients with a history of allergy to any of the drugs used in anesthesia for PROSM
  • severe cardiac dysfunction (cardiac failure)

Other

  • 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

Who the study is looking for

  • patients with elective pulmonary resections (segmentectomies, lobectomies or pneumonectomies) to treat neoplastic lung diseases.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ambulatório de Nódulos e Massas Pulmonares H Santa Marcelina
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.