First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Readmission
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
- •Moderate or high frailty
- •Syncronic neoplasia
- •Previous colorectal surgery
Outcomes
Primary Outcomes
Readmission
Time Frame: 30 days after surgery
Hospital readmission after first-day hospital discharge
Secondary Outcomes
- Postoperative complications(30 days after surgery)
- Emergency Department re-consultation(30 days after surgery)
- Domiciliary Follow-up(30 days after surgery)
Investigators
Anna Pallisera-Lloveras
MD, PhD
Corporacion Parc Tauli