Colorectal Cancer Clinical Trial
— eRCSOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Camposampiero Hospital | Camposampiero | Padova |
Lead Sponsor | Collaborator |
---|---|
Ospedale di Camposampiero |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days of hospitalization | The length of stay in hospital will be recorded in number of days | 30 days | |
Primary | 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 | Mobility score | 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 | |
Secondary | Post discharge satisfaction | 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 | |
Secondary | Overall Morbidity | Overall morbidity will be recorded considering surgical complications (surgical site infection, anastomotic leak, abdominal sepsis, ileus, postoperative bowel obstruction, bleeding) | 30 days | |
Secondary | Readmission rate | 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 |
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