Esophagectomy Enhanced Recovery After Surgery Protocol

NCT ID: NCT04750096

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-31

Brief Summary

Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in esophagectomy reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.

With the aim of improving morbimortality in patients undergoing esophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.

Detailed Description

Esophageal carcinoma is the sixth leading cause of cancer death worldwide and the main treatment still remains oesophagectomy, a technique associated with a high morbidity and mortality rate. Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in these patients reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery.

With the aim of improving morbimortality in patients undergoing oesophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.

The secondary objectives are to analyse the changes produced in terms of morbimortality after the implementation of the protocol and the repercussion of these changes on the length of stay in the Resuscitation Unit.

To carry out this project, data obtained in the first instance from patients operated before the implementation of the enhanced recovery after surgery protocol will be compared with data obtained prospectively after the implementation of the protocol.

The data will be collected from the computerised and digitalised medical records of the patients on Orion Clinic® and Interspace intelligence Critical Care and Anesthesia, Philips ®. Patients operated on between 19 October 2020 and 19 October 2021 will be included consecutively. Prior to the operation, patients must sign an informed consent form to authorize the monitoring of their data during the first 30 days after the operation. These data will include:

• Days of stay
• Development or not of respiratory failure on initial admission, as well as the ventilatory therapy used (non-invasive and invasive) and days of mechanical ventilation
• Fluid balance at 24 hours
• Adequate completion of the protocol on a post-operative basis. The items of the protocol completed during the postoperative period will be detailed, taking into account the following points:

1. Use of epidural analgesia

2. Adequate pain control

3. Realisation of neutral or negative balances

4. Introduction of enteral nutrition by jejunostomy

5. Performance of respiratory physiotherapy

6. Use of high-flow nasal glasses with a minimum flow of 40 litres.

7. Start of sedation on the second post-operative day

8. Antithrombotic prophylaxis

• The need or not for new drains and the reason for their installation will also be collected in order to evaluate the effectiveness of the transhiatal drains included in our protocol.

Data regarding re-entry will be collected on

• Reason for re-entry
• Evolutionary day after surgery when readmission took place (day 1 being counted as the day of esophagectomy)
• Days in the Critical Care Unit
• Development or not of respiratory insufficiency, and in positive cases, requirement of invasive or non-invasive mechanical ventilation and days of therapy with it.

Finally, the morbidity and mortality variables will be collected:

• Respiratory complications: pleural effusion, atelectasis, pneumothorax, pneumonia, adult respiratory distress syndrome (ARDS).
• The development of complications other than respiratory ones.
• The need for reintervention and the underlying cause.
• If exits occur, as well as the cause of death in hospital or in the first 30 days after surgery.

The data will be analysed using Statistical Package for the Social Sciences software ® (version 12).

Conditions

Esophagectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Esophagectomy post enhanced recovery after surgery

Patients undergoing esophagectomy due to oesophageal cancer under Enhanced Recovery After Surgery protocol.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients undergone esophagectomy due to neoplastic causes
• Ages between 18 and 90
• Programmed surgery

Exclusion Criteria

• Caustic esophagitis
• Esophagectomy for stomach cancer
• Congenital oesophageal malformations

• Respiratory failure at the time of surgery
• Re-interventions of esophagectomy
• Unexpected intraoperative surgical problems

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Raquel Ferrandis Comes

OTHER

Sponsor Role: lead

Responsible Party

Raquel Ferrandis Comes

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

La Fe University and Polytechnic Hospital

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Silvia Polo, Medical specialist

Role: CONTACT

silpomar@mail.ucv.es

+34 690 85 39 26

Silvia Polo, Medical Specialist

Role: CONTACT

silpomar@mail.ucv.es

+ 34 690 85 39 26

Facility Contacts

Silvia Polo, Medical specialist

Role: primary

silpomar@mail.ucv.es

+ 34 690 85 39 26

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Other Identifiers

ERASE 001

Identifier Type: -

Identifier Source: org_study_id