- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05408182
Early Discharge After Robotic Colorectal Surgery (eRCS): a Prospective Observational Study (eRCS)
Feasibility and Outcomes of an Early Discharge Protocol for Robotic Colorectal Surgery (eRCS): a Prospective Observational Study Open to International Collaboration
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Emilio Morpurgo, Dr
- Phone Number: 00393386018891
- Email: emilio.morpurgo@aulss6.veneto.it
Study Contact Backup
- Name: Stefan Morarasu, Dr
- Phone Number: 0040754490870
- Email: morarasu.stefan@gmail.com
Study Locations
-
-
Padova
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Camposampiero, Padova, Italy, 35012
- Camposampiero Hospital
-
Contact:
- Emilio Morpurgo
- Email: emilio.morpurgo@aulss6.veneto.it
-
Contact:
- Stefan Morarasu
- Email: morarasu.stefan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of hospitalization
Time Frame: 30 days
|
The length of stay in hospital will be recorded in number of days
|
30 days
|
Postoperative pain score
Time Frame: 30 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility score
Time Frame: 30 days
|
Level of mobility will be recorded at postoperative days 1, 2, 3 and day of discharge (if > 72h).
Mobility scale: 0 = not mobilizing; 1 = able to walk with assistance; 2 = able to walk without assistance; 3 = caring for himself with assistance; 4 = caring for himself independently; 5 = fully independent, but not as before the operation; 6 = fully independent, similar to before the operation
|
30 days
|
Post discharge satisfaction
Time Frame: 30 days
|
Patient reported satisfaction with treatment will be measured on the 3rd day after discharge (if patient was discharged before postoperative day 3) and/or at 30 days postoperatively. Satisfaction scale at initial post discharge assessment: 1 = unhappy with current plan/requests readmission; 2 = feels should have stayed longer in hospital, but will manage at home; 4 = now he is happy with plan/early discharge, but initially unhappy; 5 = happy with plan/early discharge Satisfaction scale at 30 days postoperatively: 1 = unhappy with care; 2 = unhappy, feels should have stayed longer in hospital; 4 = unhappy, feels should have been more closely followed-up; 5 = initially was unhappy, but now feels management plan was appropriate; 6 = happy with care received |
30 days
|
Overall Morbidity
Time Frame: 30 days
|
Overall morbidity will be recorded considering surgical complications (surgical site infection, anastomotic leak, abdominal sepsis, ileus, postoperative bowel obstruction, bleeding)
|
30 days
|
Readmission rate
Time Frame: 30 days
|
Readmissions in the first 30 days postoperatively will be recorded.
Duration of inpatient stay during readmission and type of management (e.g., reintervention, invasive procedure such as interventional radiology, medical care) will be described.
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emilio Morpurgo, Department of Surgery Hospital Camposampiero Azienda ULSS 6 Euganea
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCamposampiero
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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