Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-08-23
Brief Title:
First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery
Sponsor:
Corporacion Parc Tauli
Organization:
Corporacion Parc Tauli
Study Overview
Official Title:
First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None