Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Postoperative Complications | — | UNRESOLVED | — |
| Postoperative Nausea | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PROSM guidelines for preoperative, anesthesia and postoperative care for lung resections | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Conventional
- description
- The participants of this arm will receive the convencional pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms
- type
- EXPERIMENTAL
- label
- PROSM interventional
- description
- The participants of this arm will receive the PROSM protocol pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms
- interventionNames
- Other: PROSM guidelines for preoperative, anesthesia and postoperative care for lung resections
Primary outcomes (2)
- measure
- length of hospitalization in days
- timeFrame
- 1825 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with elective pulmonary resections (segmentectomies, lobectomies or pneumonectomies) to treat neoplastic lung diseases. Exclusion Criteria: * 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 * allergy to latex * patients with a history of allergy to any of the drugs used in anesthesia for PROSM * patients with renal dysfunction * liver dysfunction * severe cardiac dysfunction (cardiac failure)
References
Publications (7)
- BACKGROUNDDong Q, Zhang K, Cao S, Cui J. Fast-track surgery versus conventional perioperative management of lung cancer-associated pneumonectomy: a randomized controlled clinical trial. World J Surg Oncol. 2017 Jan 13;15(1):20. doi: 10.1186/s12957-016-1072-5. PMID 28086896
- BACKGROUNDWolk S, Meissner T, Linke S, Mussle B, Wierick A, Bogner A, Sturm D, Rahbari NN, Distler M, Weitz J, Welsch T. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1. PMID 28222805
- BACKGROUNDJones NL, Edmonds L, Ghosh S, Klein AA. A review of enhanced recovery for thoracic anaesthesia and surgery. Anaesthesia. 2013 Feb;68(2):179-89. doi: 10.1111/anae.12067. Epub 2012 Nov 5. PMID 23121400
- BACKGROUNDKomatsu T, Kino A, Inoue M, Sowa T, Takahashi K, Fujinaga T. Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery. Int J Surg. 2014;12(9):936-9. doi: 10.1016/j.ijsu.2014.07.272. Epub 2014 Aug 1. PMID 25091399
- BACKGROUNDDas-Neves-Pereira JC, Bagan P, Coimbra-Israel AP, Grimaillof-Junior A, Cesar-Lopez G, Milanez-de-Campos JR, Riquet M, Biscegli-Jatene F. Fast-track rehabilitation for lung cancer lobectomy: a five-year experience. Eur J Cardiothorac Surg. 2009 Aug;36(2):383-91; discussion 391-2. doi: 10.1016/j.ejcts.2009.02.020. Epub 2009 Mar 26. PMID 19324571
- BACKGROUNDChen L, Sun L, Lang Y, Wu J, Yao L, Ning J, Zhang J, Xu S. Fast-track surgery improves postoperative clinical recovery and cellular and humoral immunity after esophagectomy for esophageal cancer. BMC Cancer. 2016 Jul 11;16:449. doi: 10.1186/s12885-016-2506-8. PMID 27401305
- BACKGROUNDAsteriou C, Lazopoulos A, Rallis T, Gogakos AS, Paliouras D, Barbetakis N. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study. J Minim Access Surg. 2016 Jul-Sep;12(3):209-13. doi: 10.4103/0972-9941.183483.