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

NCT06008834 | Unknown

• 1 other identifier: CIR2022020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Disorders; Surgery

Outcome Measures

Primary Outcomes (1)

• Readmission

  Hospital readmission after first-day hospital discharge

  30 days after surgery

Secondary Outcomes (3)

• Postoperative complications

  30 days after surgery

• Emergency Department re-consultation

  30 days after surgery

• Domiciliary Follow-up

  30 days after surgery

Study Arms (1)

Interventional group

EXPERIMENTAL

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

Interventions

First-day discharge protocol PROCEDURE

Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up

Interventional group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Parc Tauli University Hospital

Sabadell, Barcelona, 08208, Spain

Location

Study Officials

• Anna Pallisera-Lloveras, MD, PhD

  Corporacio Parc Tauli. Parc Tauli University Hospital

  PRINCIPAL INVESTIGATOR

• Laura Mora-Lopez, MD, PhD

  Corporacio Parc Tauli. Parc Tauli University Hospital

  STUDY DIRECTOR

• Oriol Pino-Perez, MD

  Corporacio Parc Tauli. Parc Tauli University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Pallisera-Lloveras, MD, PhD

CONTACT

34-93-723-1010; apallill@gmail.com

Laura Mora-Lopez, MD, PhD

CONTACT

34-93-723-1010; mora.lopez.laura@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Single Group Interventional Pilot Study.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 24, 2023
• Study Start: October 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

ES (1)