Clinical trial NCT06008834: First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery
Official title: First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Disorders
Surgery
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Interventional Pilot Study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Readmission
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days after surgery
measure: Emergency Department re-consultation
timeFrame: 30 days after surgery
measure: Domiciliary Follow-up
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli University Hospital
state: Barcelona
Study officials:
affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
name: Anna Pallisera-Lloveras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
name: Laura Mora-Lopez, MD, PhD
role: STUDY_DIRECTOR
affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
name: Oriol Pino-Perez, MD
role: PRINCIPAL_INVESTIGATOR
References: