First-day Discharge Enhanced Recovery After Surgery Proto... | NCT06008834

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

NCT06008834

Sponsor

Corporacion Parc Tauli

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Colorectal Disorders
Surgery

Interventions

First-day discharge protocol

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Estimated

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jul 30, 2024Estimated

First Submitted Date

Aug 23, 2023

First Submission Date that Met QC Criteria

Aug 23, 2023

First Posted Date

Aug 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2023

Last Update Posted Date

Sep 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anna Pallisera-Lloveras, MD, PhD, Corporacion Parc TauliPrincipal Investigator

Lead Sponsor

Corporacion Parc TauliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional group	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
First-day discharge protocol	Procedure	Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Readmission	Hospital readmission after first-day hospital discharge	30 days after surgery

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)
Dementia
Moderate or high frailty
Syncronic neoplasia
Previous colorectal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Pallisera-Lloveras, MD, PhD	Contact	34-93-723-1010	21490	apallill@gmail.com
Laura Mora-Lopez, MD, PhD	Contact	34-93-723-1010	21490	mora.lopez.laura@gmail.com

Overall Officials

Name	Affiliation	Role
Anna Pallisera-Lloveras, MD, PhD	Corporacio Parc Tauli. Parc Tauli University Hospital	Principal Investigator
Laura Mora-Lopez, MD, PhD	Corporacio Parc Tauli. Parc Tauli University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parc Tauli University Hospital		Sabadell	Barcelona	08208	Spain