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

Not Applicable

Not yet recruiting

• Conditions: Surgery; Colorectal Disorders
• Interventions: Procedure: First-day discharge protocol

• Registration Number: NCT06008834
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Study Start: 2023-10-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional group	First-day discharge protocol	Patients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up

Primary Outcome Measures

Name	Time	Method
Readmission	30 days after surgery	Hospital readmission after first-day hospital discharge

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days after surgery	Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification
Emergency Department re-consultation	30 days after surgery	Emergency Department re-consultation with no readmission after first-day hospital discharge
Domiciliary Follow-up	30 days after surgery	Domiciliary follow-up mean time before domiciliary discharge

Trial Locations

Locations (1)

Parc Tauli University Hospital; 🇪🇸 Sabadell, Barcelona, Spain