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

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06008834
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
10.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: First-day discharge protocol
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group Interventional Pilot Study.Single Group Interventional Pilot Study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional group

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

Outcome Measures

Primary Outcome Measures

  1. Readmission [30 days after surgery]

    Hospital readmission after first-day hospital discharge

Secondary Outcome Measures

  1. Postoperative complications [30 days after surgery]

    Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification

  2. Emergency Department re-consultation [30 days after surgery]

    Emergency Department re-consultation with no readmission after first-day hospital discharge

  3. Domiciliary Follow-up [30 days after surgery]

    Domiciliary follow-up mean time before domiciliary discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parc Tauli University Hospital Sabadell Barcelona Spain 08208

Sponsors and Collaborators

  • Corporacion Parc Tauli

Investigators

  • Principal Investigator: Anna Pallisera-Lloveras, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital
  • Study Director: Laura Mora-Lopez, MD, PhD, Corporacio Parc Tauli. Parc Tauli University Hospital
  • Principal Investigator: Oriol Pino-Perez, MD, Corporacio Parc Tauli. Parc Tauli University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anna Pallisera-Lloveras, MD, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT06008834
Other Study ID Numbers:
  • CIR2022020
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 31, 2023