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

Corporacion Parc Tauli

Status: Not yet enrolling

Conditions: Surgery; Colorectal Disorders

Treatments: Procedure: First-day discharge protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06008834

CIR2022020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Interventional group

Experimental group

Description:

Patients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up

Treatment:

Procedure: First-day discharge protocol