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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06008834
Enrollment
40
Registered
2023-08-24
Start date
2023-10-01
Completion date
2024-07-30
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Disorders, Surgery

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.

Interventions

PROCEDUREFirst-day discharge protocol

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

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single Group Interventional Pilot Study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Readmission30 days after surgeryHospital readmission after first-day hospital discharge

Secondary

MeasureTime frameDescription
Postoperative complications30 days after surgeryPostoperative complications after first-day hospital discharge acording to Clavien-Dindo classification
Emergency Department re-consultation30 days after surgeryEmergency Department re-consultation with no readmission after first-day hospital discharge
Domiciliary Follow-up30 days after surgeryDomiciliary follow-up mean time before domiciliary discharge

Countries

Spain

Contacts

Primary ContactAnna Pallisera-Lloveras, MD, PhD
apallill@gmail.com34-93-723-1010
Backup ContactLaura Mora-Lopez, MD, PhD
mora.lopez.laura@gmail.com34-93-723-1010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026