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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06008834
• Other study ID #: CIR2022020
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: September 2023
• Source: Corporacion Parc Tauli
• Contact: Anna Pallisera-Lloveras, MD, PhD
• Phone: 34-93-723-1010
• Email: apallill[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Disorders
• Surgery

Intervention

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

Locations

Country	Name	City	State
Spain	Parc Tauli University Hospital	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission	Hospital readmission after first-day hospital discharge	30 days after surgery
Secondary	Postoperative complications	Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification	30 days after surgery
Secondary	Emergency Department re-consultation	Emergency Department re-consultation with no readmission after first-day hospital discharge	30 days after surgery
Secondary	Domiciliary Follow-up	Domiciliary follow-up mean time before domiciliary discharge	30 days after surgery