Clinical trial NCT05408182: Early Discharge After Robotic Colorectal Surgery (eRCS): a Prospective Observational Study
Official title: Feasibility and Outcomes of an Early Discharge Protocol for Robotic Colorectal Surgery (eRCS): a Prospective Observational Study Open to International Collaboration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Surgery-Complications
Lead sponsor: Ospedale di Camposampiero
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: Days of hospitalization
timeFrame: 30 days
measure: Postoperative pain score
timeFrame: 30 days
Secondary outcomes:
measure: Mobility score
timeFrame: 30 days
measure: Post discharge satisfaction
timeFrame: 30 days
measure: Overall Morbidity
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Camposampiero
country: Italy
facility: Camposampiero Hospital
state: Padova
Study officials:
affiliation: Department of Surgery Hospital Camposampiero Azienda ULSS 6 Euganea
name: Emilio Morpurgo
role: PRINCIPAL_INVESTIGATOR
References: