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

NCT03271749 | Not Yet Recruiting

• 1 other identifier: 70142917.0.0000.0066
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment and hospitalization of these patients.

Conditions

Postoperative Pain; Postoperative Complications; Postoperative Nausea; Lung Cancer

Keywords

Fast Track surgical recovery; Surgical recovery; Thoracic surgery

Outcome Measures

Primary Outcomes (2)

• length of hospitalization in days

  To evaluate the impact of PROSM on the length of hospitalization in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital

  1825 days

• postoperative pain using visual analog pain scale (VAS)

  To evaluate the impact of PROSM on postoperative pain in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital

  1825 days

Secondary Outcomes (1)

• costs of surgical treatment in US dollars

  1825 days

Study Arms (2)

Conventional

NO INTERVENTION

The participants of this arm will receive the convencional pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms

PROSM interventional

EXPERIMENTAL

The participants of this arm will receive the PROSM protocol pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms

Other: PROSM guidelines for preoperative, anesthesia and postoperative care for lung resections

Interventions

PROSM guidelines for preoperative, anesthesia and postoperative care for lung resections OTHER

The PROSM guidelines is described previously in study description

PROSM interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Igor Renato Louro Bruno de Abreu: lead

Study Sites (1)

Ambulatório de Nódulos e Massas Pulmonares H Santa Marcelina

São Paulo, São Paulo, 08270070, Brazil

Location

Related Publications (7)

• Dong 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 BACKGROUND

• Wolk 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 BACKGROUND

• Jones 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 BACKGROUND

• Komatsu 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 BACKGROUND

• Das-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 BACKGROUND

• Chen 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 BACKGROUND

• Asteriou 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.

  PMID: 27279390 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Postoperative Nausea and Vomiting; Lung Neoplasms

Interventions

Anesthesia; Postoperative Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fernando C Abrão, M.D.

  Coordinating physician of the thoracic surgery team of Santa Marcelina de Itaquera Hospital

  STUDY CHAIR

Central Study Contacts

Igor Renato LB de Abreu, M.D.

CONTACT

55(11)982035629; dr.igor.abreu@gmail.com

Fernando C Abrão, M.D.

CONTACT

55(11) 982255088; torax.santa.marcelina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It's impossible to mask the participants, care providers and investigators, because of the apparent differences in both techniques. For this reason the data analysis will be masked to avoid influences by the other participants during the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant physician of the thoracic surgery team of the Hospital Santa Marcelina de Itaquera

Model Details: Randomized controlled Trial

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: July 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

BR (1)