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

Study Overview
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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.

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.

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

Conditions
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Surgery, Colorectal Disorders

Intervention / Treatment
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* Procedure: First-day discharge protocol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Interventional Pilot Study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>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<br>* Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up<br>|

What is the study measuring?
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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 |