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

NCT ID: NCT05408182

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-01-01

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.

Detailed Description

This is a prospective observational study open to collaboration with international centers with expertise in robotic colorectal surgery. 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. Patient will be followed-up clinically through pain scores, mobility scores, satisfaction and postoperative outcomes (e.g., surgical site infections, leaks, ileus, readmissions) to assess their recovery within the first 30 days postoperatively. The subgroup of patients which will be discharged on postoperative day 1 (POD 1) will form the 24h surgery group. These patients will also be closely followed-up virtually and through the outpatient department for blood samples and clinical examination.

All data on patients including follow-up data will be recorded in an encrypted Excel database. Patient will be followed-up according to the above plan up to 30 days postoperatively, when they will be asked to fill in a questionnaire to assess patient reported experience (VAS score, mobility score and satisfaction rate). Postoperative complications and readmissions will be recorded.

Main outcomes:

• Postoperative day of discharge (early 1, intermediate 2, standard 3-5)
• Patient reported outcomes: pain score (VAS), mobility score, nausea score, food tolerance score, satisfaction rate during admission, on day of discharge, on days 2, 4 and 7 for patient discharged on POD 1 and for all patients at POD 30
• Postoperative complications: surgical site infection, urinary infection, other source of sepsis, ileus, intraabdominal sepsis, anastomotic leak, cardiovascular complications, respiratory complications
• Readmission rate, reintervention rate

Conditions

Colorectal Cancer; Surgery-Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Robotic colorectal resection with ERAS (or eRCS) perioperative care

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ospedale di Camposampiero

OTHER

Sponsor Role: lead

Responsible Party

Stefan Morarasu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilio Morpurgo

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery Hospital Camposampiero Azienda ULSS 6 Euganea

Locations

Camposampiero Hospital

Camposampiero, Padova, Italy

Countries

Italy

Central Contacts

Emilio Morpurgo, Dr

Role: CONTACT

emilio.morpurgo@aulss6.veneto.it

00393386018891

Stefan Morarasu, Dr

Role: CONTACT

morarasu.stefan@gmail.com

0040754490870

Facility Contacts

Emilio Morpurgo

Role: primary

emilio.morpurgo@aulss6.veneto.it

Stefan Morarasu

Role: backup

morarasu.stefan@gmail.com

Other Identifiers

OCamposampiero

Identifier Type: -

Identifier Source: org_study_id