Colorectal CancereRCSNCT05408182
Early Discharge After Robotic Colorectal Surgery (eRCS): a Prospective Observational Study
An observational study of Colorectal Cancer and Surgery-Complications, run by Ospedale di Camposampiero at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Surgery-Complications
- What is being tested?
- Robotic colorectal resection with ERAS (or eRCS) perioperative care
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 1 Jan 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Camposampiero Hospital
Camposampiero, Padova, 35012
Emilio Morpurgo, emilio.morpurgo@aulss6.veneto.it
Stefan Morarasu, morarasu.stefan@gmail.com
About this study
Official 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.
Read the 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
- Being tested
- Robotic colorectal resection with ERAS (or eRCS) perioperative care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic colorectal resection with ERAS (or eRCS) perioperative careProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of hospitalization
The length of stay in hospital will be recorded in number of days
Measured: 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.
Measured: 30 days
Secondary outcomes (4)
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
Measured: 30 days
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
Measured: 30 days
Overall Morbidity
Overall morbidity will be recorded considering surgical complications (surgical site infection, anastomotic leak, abdominal sepsis, ileus, postoperative bowel obstruction, bleeding)
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ospedale di Camposampiero
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Morarasu, Ospedale di Camposampiero
- Investigators
- Emilio Morpurgo, Principal investigator, Department of Surgery Hospital Camposampiero Azienda ULSS 6 Euganea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408182
- Sponsor's protocol ID
- OCamposampiero
- Acronym
- eRCS
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Outcomes of an Early Discharge Protocol for Robotic Colorectal Surgery (eRCS): a Prospective Observational Study Open to International Collaboration
- ClinicalTrials.gov ID
- NCT05408182
- Acronym / sponsor ID
- eRCS / OCamposampiero
- Conditions
- Colorectal Cancer, Surgery-Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ospedale di CamposampieroUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Age less than 75yo
- ASA grade I and II
- Not on anticoagulation
- Elective colorectal resections
- Does not require stoma
Key exclusion criteria (9 listed)
- Age more than 75yo
- ASA grade III
- Patient on anticoagulation
- Emergency surgery
- Requires stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic colorectal resection with ERAS (or eRCS) perioperative careAll 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. | Procedure or surgery | – |
Primary outcome
Days of hospitalization
Time frame: 30 days
The length of stay in hospital will be recorded in number of 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.
4 secondary outcomes
Mobility score
Time frame: 30 days
Post discharge satisfaction
Time frame: 30 days
Overall Morbidity
Time frame: 30 days
Readmission rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Morpurgo principal investigator
Department of Surgery Hospital Camposampiero Azienda ULSS 6 Euganea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Surgery-Complications, run by Ospedale di Camposampiero at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilio Morpurgo, Dr (00393386018891, emilio.morpurgo@aulss6.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of hospitalization (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.