Implementing Enhanced Recovery After Surgery (ERAS) Protocol in Patients Undergoing Minimal Invasive Esophagectomy

NCT06243887 | Not Yet Recruiting

• 1 other identifier: Minimal invasive esophegectomy
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Detect impact of enhanced recovery after surgery (ERAS) on the outcomes of oesophageal surgery .

Conditions

Esophageal Diseases; Esophagostomy Complication

Outcome Measures

Primary Outcomes (1)

• Enhanced recovery after surgery (ERAS)

  Detect impact of enhanced recovery after surgery on the outcomes of oesophageal surgery concerning 1. time to out-of-bed activity 2. time to first flatus 3. time to liquid diet 4. postoperative hospital stay 5. ICU length of stay 6. ICU length of stay 7. in-hospital mortality 8. incidence of various postoperative complications

  average 2 years

Secondary Outcomes (1)

• Enhanced recovery after surgery (ERAS)

  average 2 years

Study Arms (2)

Conventional group

OTHER

patients of minimally invasive esophagectomy with standard of care approaches

Other: standard of care approaches in minimal invasive esophagectomy

ERAS group

OTHER

patients of minimally invasive esophagectomy with enhanced recovery after surgery protocol

Other: Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy

Interventions

Enhanced Recovery After Surgery (ERAS) protocol in minimal invasive esophagectomy OTHER

Enhanced Recovery After Surgery (ERAS) refers to patient-centered, evidence-based, multidisciplinary team developed pathways for a surgical specialty and facility culture to reduce the patient's surgical stress response, optimize their physiologic function, and facilitate recovery.

ERAS group

standard of care approaches in minimal invasive esophagectomy OTHER

standard of care approaches other than ERAS

Conventional group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) first detected and endoscopically confirmed esophageal cancer; 2)preoperative evaluation showed no distant metastases and suitable for MIE; 3preoperative clinical stage of I to III

You may not qualify if:

• \) patients had a history of thoracic or abdominal surgery; 2)patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system; 3)patients had other malignancies; 4)patients had missing clinical data

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Puccetti F, Klevebro F, Kuppusamy M, Han S, Fagley RE, Low DE, Hubka M. Analysis of Compliance with Enhanced Recovery After Surgery (ERAS) Protocol for Esophagectomy. World J Surg. 2022 Dec;46(12):2839-2847. doi: 10.1007/s00268-022-06722-7. Epub 2022 Sep 22.

  PMID: 36138318 BACKGROUND

• Shen Y, Chen X, Hou J, Chen Y, Fang Y, Xue Z, D'Journo XB, Cerfolio RJ, Fernando HC, Fiorelli A, Brunelli A, Cang J, Tan L, Wang H; Written on behalf of the AME Thoracic Surgery Collaborative Group. The effect of enhanced recovery after minimally invasive esophagectomy: a randomized controlled trial. Surg Endosc. 2022 Dec;36(12):9113-9122. doi: 10.1007/s00464-022-09385-6. Epub 2022 Jun 30.

  PMID: 35773604 BACKGROUND

MeSH Terms

Conditions

Esophageal Diseases

Interventions

Enhanced Recovery After Surgery; Clinical Protocols

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Khaled Hussein, master

CONTACT

+201098315303; khaledhassaan81@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: February 6, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 22, 2024

Record last verified: 2024-03