First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery

First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study

The enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.

Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.

Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up. Hospital readmission is considered as the primary outcome. A total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies. An independent analysis of both techniques will be performed.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Colorectal Disorders
• Intervention / Treatment: Procedure: First-day discharge protocol

Detailed Description

Introduction: the enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.

Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.

Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up.

Outcomes:

• Primary: hospital readmission
• Secondary: postoperative complications (Clavien-Dindo), domiciliary follow-up mean time before final postoperative discharge, emergency department re-consulting.

Sample: a total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies.

Analysis: an independent analysis of both techniques will be performed. Pilot study without control branch.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Pallisera-Lloveras, MD, PhD; Phone Number: 21490 34-93-723-1010; Email: apallill@gmail.com
• Study Contact Backup: Name: Laura Mora-Lopez, MD, PhD; Phone Number: 21490 34-93-723-1010; Email: mora.lopez.laura@gmail.com

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Parc Taulí University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pacients who undergo a minimal invasive sigmoidectomy or right colectomy.
• Benign or malignant desease.
• No expected stoma
• ASA ≤ III
• Family support

Exclusion Criteria:

• Emergency surgery
• Anticoagulant therapy
• Recent immunosupresor therapy (less than one month)
• Anemia (Male Hb >120 g/L, Female Hb >110 g/L)
• Malnutrition (Albumine >35 g/L)
• Dementia
• Moderate or high frailty
• Syncronic neoplasia
• Previous colorectal surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; Patients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up	Procedure: First-day discharge protocol; Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission	Hospital readmission after first-day hospital discharge	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification	30 days after surgery
Emergency Department re-consultation	Emergency Department re-consultation with no readmission after first-day hospital discharge	30 days after surgery
Domiciliary Follow-up	Domiciliary follow-up mean time before domiciliary discharge	30 days after surgery

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Anna Pallisera-Lloveras, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital; Study Director: Laura Mora-Lopez, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital; Principal Investigator: Oriol Pino-Perez, MD, Corporacio Parc Tauli. Parc Tauli University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CIR2022020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No