Early Discharge After Robotic Colorectal Surgery (eRCS): a Prospective Observational Study

NCT05408182 | Unknown

• 1 other identifier: OCamposampiero
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The enhanced recovery after surgery (ERAS) scheme has improved recovery of patients by addressing the surgical stress and enabling a proactive perioperative care which has proven to decrease postoperative complications and reduce hospital stay. ERAS had a major beneficial effect in open colorectal surgery, while in laparoscopic surgery the additional benefit was somewhat less. Also, current literature is not clear if ERAS can improve operative outcomes of robotic colorectal surgery. Starting from the already proven ERAS protocol, we aim to build a selective enhanced recovery scheme and a standardized early follow-up pathway enabling early safe discharge of low-risk patients after robotic colorectal surgery. This observational study will also design and assess the feasibility and clinical outcomes of an Early discharge Colorectal Surgery (eRCS) protocol which may be used to discharge patients in postoperative day 1 after robotic colorectal resections through close virtual and outpatient follow-up.

Conditions

Colorectal Cancer; Surgery-Complications

Outcome Measures

Primary Outcomes (2)

• Days of hospitalization

  The length of stay in hospital will be recorded in number of days

  30 days

• Postoperative pain score

  Level of postoperative pain will be recorded through the Visual Assessment Scale (VAS). Patient will score level of pain from 1 (no pain) to 10 (worst pain ever felt). Pain will be recorded on postoperative days 1, 2, 3, 5, 7 and 30. Pain score will be measured at rest and when patient is mobilizing.

  30 days

Secondary Outcomes (4)

• Mobility score

  30 days

• Post discharge satisfaction

  30 days

• Overall Morbidity

  30 days

• Readmission rate

  30 days

Interventions

Robotic colorectal resection with ERAS (or eRCS) perioperative care PROCEDURE

All patients will undergo robotic colorectal resections using the Da Vinci xi system. All common colorectal procedures will be included: right/left colectomy, sigmoid colectomy, anterior resection with PME/TME/TaTME. Patient will undergo an enhanced recovery pathway perioperatively ensuring prompt recovery and early discharge. Most ERAS guidelines will be followed including preoperative nutrition, behavioral training, avoidance of drains, NG tubes, catheters, opioids, patient based volume repletion, wound local anesthetic infiltration, early mobilization, early postoperative feeding, spirometry and physiotherapy.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort will include adult patients, categorized as low risk based on the inclusion criteria which will undergo elective colorectal surgery under the governance of ERAS to enable early discharge.

You may qualify if:

• Age less than 75yo
• ASA grade I and II
• Not on anticoagulation
• Elective colorectal resections
• Does not require stoma
• No intraoperative complications (surgical team happy with procedure)
• Patient/Caregiver thoroughly counselled about the aim and each step of the protocol (for patients which will be discharged on POD 1)
• Patient/Caregiver understands what to expect and knows how to manage possible issues (for patients which will be discharged on POD 1)
• Patient/Caregiver has a direct line to the Nurse Practitioner/Surgical team member (for patients which will be discharged on POD 1)
• Able to attend virtual and clinic follow-up in the first 10 days postoperatively (transport to hospital available - for patients which will be discharged on POD 1)

You may not qualify if:

• Age more than 75yo
• ASA grade III
• Patient on anticoagulation
• Emergency surgery
• Requires stoma
• Intraoperative complications: iatrogenic injuries, significant bleeding, anaesthetic issues, new significant pathology encountered, complicated procedure, conversion to open surgery
• Patient/Caregiver refuses early discharge
• Caregiver not available to support patient at home (for patients which will be discharged on POD 1)
• Cannot attend virtual or/and clinical follow-up if discharged on POD 1

Sponsors & Collaborators

• Ospedale di Camposampiero: lead

Study Sites (1)

Camposampiero Hospital

Camposampiero, Padova, 35012, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Perioperative Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Emilio Morpurgo

  Department of Surgery Hospital Camposampiero Azienda ULSS 6 Euganea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio Morpurgo, Dr

CONTACT

00393386018891; emilio.morpurgo@aulss6.veneto.it

Stefan Morarasu, Dr

CONTACT

0040754490870; morarasu.stefan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

IT (1)