Colorectal DisordersNCT06008834
First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery
A study testing First-day discharge protocol in people with Colorectal Disorders and Surgery, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Disorders, Surgery
- What is being tested?
- First-day discharge protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 30 Jul 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pacients who undergo a minimal invasive sigmoidectomy or right colectomy.
- Benign or malignant desease.
- No expected stoma
- ASA ≤ III
- Family support
Who cannot join
- Emergency surgery
- Anticoagulant therapy
- Recent immunosupresor therapy (less than one month)
- Anemia (Male Hb >120 g/L, Female Hb >110 g/L)
- Malnutrition (Albumine >35 g/L)
- Dementia
Show all 9Show fewer
- Moderate or high frailty
- Syncronic neoplasia
- Previous colorectal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study
The enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.
Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.
Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up. Hospital readmission is considered as the primary outcome. A total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies. An independent analysis of both techniques will be performed.
Read the detailed description
Introduction: the enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.
Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.
Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up.
Outcomes:
- Primary: hospital readmission
- Secondary: postoperative complications (Clavien-Dindo), domiciliary follow-up mean time before final postoperative discharge, emergency department re-consulting.
Sample: a total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies.
Analysis: an independent analysis of both techniques will be performed. Pilot study without control branch.
- Conditions
- Colorectal Disorders, Surgery
- Being tested
- First-day discharge protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-day discharge protocolProcedure or surgery
Enhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up Receives: Procedure: First-day discharge protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Hospital readmission after first-day hospital discharge
Measured: 30 days after surgery
Secondary outcomes (3)
Postoperative complications
Postoperative complications after first-day hospital discharge acording to Clavien-Dindo classification
Measured: 30 days after surgery
Emergency Department re-consultation
Emergency Department re-consultation with no readmission after first-day hospital discharge
Measured: 30 days after surgery
Domiciliary Follow-up
Domiciliary follow-up mean time before domiciliary discharge
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Interventional Pilot Study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Pallisera-Lloveras, Corporacion Parc Tauli
- Investigators
- Anna Pallisera-Lloveras, MD, PhD, Principal investigator, Corporacio Parc Tauli. Parc Tauli University HospitalLaura Mora-Lopez, MD, PhD, Study director, Corporacio Parc Tauli. Parc Tauli University HospitalOriol Pino-Perez, MD, Principal investigator, Corporacio Parc Tauli. Parc Tauli University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008834
- Sponsor's protocol ID
- CIR2022020
- Status last verified
- Sep 2023
- First submitted
- 23 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-day Discharge Enhanced Recovery After Surgery Protocol for Minimal Invasive Colorectal Surgery: Pilot Study
- ClinicalTrials.gov ID
- NCT06008834
- Acronym / sponsor ID
- CIR2022020
- Conditions
- Colorectal Disorders, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 24 Aug 2023 (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) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.
Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.
Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up. Hospital readmission is considered as the primary outcome. A total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies. An independent analysis of both techniques will be performed.
Detailed description
Introduction: the enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization. This type of approach has led to an earlier hospital discharge of patients with a low rate of postoperative complications.
Purpose: the aim of this study is to evaluate an ERAS protocol with fist-day hospital discharge and domiciliary follow-up for minimal invasive colectomy.
Method: unicenter pilot study of patients with indication of minimally invasive right colectomy or sigmidectomy who will follow an ERAS protocol according to international guidelines and will be discharged the first day of surgery with a domiciliary follow-up.
Outcomes:
- Primary: hospital readmission
- Secondary: postoperative complications (Clavien-Dindo), domiciliary follow-up mean time before final postoperative discharge, emergency department re-consulting.
Sample: a total sample of 40 cases is considered, with 20 right colectomies and 20 sigmoidectomies.
Analysis: an independent analysis of both techniques will be performed. Pilot study without control branch.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Interventional Pilot Study.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Procedure: First-day discharge protocolPatients who undergo a minimal invasive colorectal surgery and are included in the first-day discharge protocol with domiciliary follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pacients who undergo a minimal invasive sigmoidectomy or right colectomy.
- Benign or malignant desease.
- No expected stoma
- ASA ≤ III
- Family support
Key exclusion criteria (9 listed)
- Emergency surgery
- Anticoagulant therapy
- Recent immunosupresor therapy (less than one month)
- Anemia (Male Hb >120 g/L, Female Hb >110 g/L)
- Malnutrition (Albumine >35 g/L)
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 |
|---|---|---|
| First-day discharge protocolEnhance Recovery after Surgery (ERAS) protocol consisting in perioperative mesures and first-day hospital discharge with domiciliary follow-up | Procedure or surgery | Interventional group |
Primary outcome
Readmission
Time frame: 30 days after surgery
Hospital readmission after first-day hospital discharge
3 secondary outcomes
Postoperative complications
Time frame: 30 days after surgery
Emergency Department re-consultation
Time frame: 30 days after surgery
Domiciliary Follow-up
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
Anna Pallisera-Lloveras, MD, PhD principal investigator
Corporacio Parc Tauli. Parc Tauli University Hospital
Laura Mora-Lopez, MD, PhD study director
Corporacio Parc Tauli. Parc Tauli University Hospital
Oriol Pino-Perez, MD principal investigator
Corporacio Parc Tauli. Parc Tauli University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First-day discharge protocol in people with Colorectal Disorders and Surgery, run by Corporacion Parc Tauli at 1 site in Spain.
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 5 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 13 Sep 2023. 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 Spain. 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 Anna Pallisera-Lloveras, MD, PhD (34-93-723-1010 ext. 21490, apallill@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission (time frame: 30 days after surgery). 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 13 Sep 2023.