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Clinical Trials/NCT06008834
NCT06008834
Not yet recruiting
Not Applicable

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

Corporacion Parc Tauli1 site in 1 country40 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Disorders
Sponsor
Corporacion Parc Tauli
Enrollment
40
Locations
1
Primary Endpoint
Readmission
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
July 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

Anna Pallisera-Lloveras

MD, PhD

Corporacion Parc Tauli

Eligibility Criteria

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)
  • Moderate or high frailty
  • Syncronic neoplasia
  • Previous colorectal surgery

Outcomes

Primary Outcomes

Readmission

Time Frame: 30 days after surgery

Hospital readmission after first-day hospital discharge

Secondary Outcomes

  • Postoperative complications(30 days after surgery)
  • Emergency Department re-consultation(30 days after surgery)
  • Domiciliary Follow-up(30 days after surgery)

Study Sites (1)

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