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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Disorders Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Interventional Pilot Study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional group

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

Group Type EXPERIMENTAL

First-day discharge protocol

Intervention Type PROCEDURE

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

Interventions

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First-day discharge protocol

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No