ERASNCT06810648
Epidural Analgesia and Intraoperative Fluid Management in Colorectal Surgery
A study testing GDFT, GDFT/ED and CFT in people with ERAS and Colorectal Surgery, run by University of Ioannina at 2 sites in Greece.
Trial summary
The Enhanced Recovery After Surgery (ERAS) protocols have demonstrated their efficacy in expediting recovery and minimizing postoperative complications, especially in patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ERAS, Colorectal Surgery, Goal-directed Fluid Therapy
- What is being tested?
- GDFT, GDFT/ED and CFT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesGreece
- Study dates
- 1 May 2017to 23 Oct 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- elective oncological colorectal surgery
- ASA (American Society of Anesthesiologists physical status classification) I \& II
Who cannot join
- extremes of weight (< 55 kg or > 120 kg)
- known history of arrhythmias
- recent unstable coronary syndrome
- decompensated heart failure
- severe aortic valve stenosis
- impaired renal function (serum creatinine level > 2.0 mg/dL)
- inability to communicate
- refusal to provide consent
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
"Attikon" Hospital
Athens, Attica, 12462
University Hospital of Ioannina
Ioannina, Epirus, 455 00
About this study
Official title: Effect of Epidural Analgesia on Goal-Directed Fluid Therapy Using Stroke Volume Variation in Elective Major Abdominal Surgery Involving Low Risk Patients: A Cohort Study
The Enhanced Recovery After Surgery (ERAS) protocols have demonstrated their efficacy in expediting recovery and minimizing postoperative complications, especially in patients undergoing abdominal surgery. Perioperative hydration is one of the most critical pillars of the ERAS protocols, with goal-directed methods for administering fluids increasingly incorporated into these protocols.
The Goal-Directed Fluid Therapy (GDFT) method is a strategy used in perioperative and critical care settings to optimize fluid administration tailored to a patient's individual needs. Its goal is to maintain adequate tissue perfusion and oxygenation by precisely balancing fluid administration, avoiding both hypovolemia (too little fluid) and fluid overload. Rather than using a "one-size-fits-all" approach, GDFT adjusts fluid delivery based on real-time monitoring of the patient's physiological parameters. GDFT focuses on dynamic hemodynamic indicators, such as stroke volume (SV), stroke volume variation (SVV), and cardiac output (CO), which provide better insight into the patient's fluid responsiveness. Advanced monitoring tools, such as esophageal Doppler, pulse contour analysis, or invasive devices like a pulmonary artery catheter, are used to assess the patient's response to fluid administration. The implementation of such protocols, particularly in colorectal surgery, has proven beneficial, as both overhydration and underhydration in this context can significantly impair organ function and, consequently, affect patient outcomes. Hypovolemia may lead to tissue ischemia at the anastomotic site, potentially causing breakdown. Conversely, fluid overload can have harmful consequences; hyperhydration may cause tissue edema, thereby reducing anastomotic strength. However, these findings have been validated primarily in high-risk patients, with a limited number of studies involving low- to moderate-risk patients undergoing major abdominal surgery.
Read more
Colorectal surgery is routinely managed with epidural analgesia combined with general anaesthesia. However, concerns have been raised that epidurally induced sympathetic blockade and vasoplegia (vasodilation) can cause haemodynamic instability, necessitating fluid and vasopressor administration to an uncertain extent.
In this single-center trial, we aimed to investigate whether epidural analgesia, in addition to general anaesthesia, influences Stroke Volume Variation (SVV)-guided GDFT using the FloTrac/Vigileo monitor during major open abdominal surgery. The study hypothesis was that epidural analgesia may result in fluid overload to compensate for the induced vasoplegia and that this fluid overload, in turn, could lead to gastrointestinal dysfunction and prolong the length of hospital stay.
The primary outcomes were the incidence of postoperative gastrointestinal dysfunction and the length of hospital stay following elective colorectal surgery in patients managed with GDFT, either with or without epidural analgesia. Additionally, patient records of those treated with conventional fluid therapy (CFT), with or without epidural analgesia, were reviewed retrospectively for comparison.
Read the detailed description
Existing evidence regarding the implementation of Enhanced Recovery After Surgery (ERAS) protocols highlights their benefits in accelerating the recovery process and reducing hospital stay durations. Additionally, postoperative morbidity, mortality, and rehospitalization rates are lower in patients following these protocols. A key component of ERAS protocols is perioperative fluid management, which is critical for gastrointestinal recovery after major abdominal surgery. Both overhydration and underhydration can significantly impair organ function and, consequently, affect patient outcomes.
Goal-directed fluid therapy (GDFT), utilizing dynamic volume measurements, enables balanced fluid administration. Numerous studies support the implementation of such protocols, particularly in major abdominal surgeries. Colonic anastomotic leakage is one of the most serious complications following colorectal surgery, with a reported incidence of up to 20%. Anastomotic breakdown is associated with increased morbidity and mortality, resulting in prolonged hospitalization, depletion of healthcare resources, and elevated costs. Hypovolemia can lead to tissue ischemia at the anastomotic site, causing breakdown. Conversely, fluid overload may have harmful consequences; hyperhydration can lead to tissue edema, thereby reducing anastomotic strength. These findings underscore the importance of maintaining euvolemia during colorectal surgeries, supporting the inclusion of GDFT as an essential component of the anesthetic protocol. However, the benefits of GDFT in abdominal surgery have been predominantly investigated and validated in high-risk patients. Only a limited number of studies involve low- to moderate-risk patients undergoing major abdominal surgery.
Epidural analgesia, combined with general anaesthesia, is considered the gold standard anaesthetic regimen for major abdominal surgery. However, the resulting sympathetic blockade and vasoplegia can cause haemodynamic instability, affecting fluid administration and vasopressor requirements to an uncertain extent. Various clinical and laboratory markers have been employed to monitor the effects of perioperative fluid management. Evidence suggests that B-type Natriuretic Peptide (BNP) levels are associated with fluid balance, morbidity and mortality at 30 days or even 180 days after non-cardiac surgery, and length of hospital stay. However, the concept of using risk predictors such as BNP in surgeries involving significant fluid loss and redistribution, such as colorectal surgeries, remains insufficiently studied.
This single-center trial was conducted to investigate whether epidural analgesia, in addition to general anaesthesia, influences Stroke Volume Variation (SVV) guided GDFT using the FloTrac/Vigileo monitor in major open abdominal surgery. The study hypothesis was that epidural analgesia may result in overhydration to compensate for the induced vasoplegia, thereby affecting gastrointestinal function and length of hospital stay. The primary outcome was the effect of epidural analgesia on the incidence of postoperative gastrointestinal dysfunction and the length of hospital stay in low- to moderate-risk patients undergoing open major abdominal surgery managed with intraoperative GDFT. Secondary outcomes included the total volume of fluids administered, assessment of proBNP levels as a marker of fluid balance, incidence of postoperative adverse events, and all-cause in-hospital mortality. Additionally, patients' records treated with conventional fluid therapy (CFT) with or without epidural analgesia were reviewed retrospectively for comparison.
- Conditions
- ERAS, Colorectal Surgery, Goal-directed Fluid Therapy, Conventional Fluid Therapy, Epidural Analgesia
- Being tested
- GDFT, GDFT/ED, CFT, CFT/ED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDFTProcedure or surgery
Also called Prospective group
Hydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was provided with intravenous analgesics.
GDFT/EDProcedure or surgery
Also called Prospective group
Hydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was administered via epidural analgesics.
CFTProcedure or surgery
Also called Retrospective group
Patients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was provided with intravenous analgesics.
CFT/EDProcedure or surgery
Also called Retrospective group
Patients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was administered via epidural analgesics.
| Study group | Role | What they receive |
|---|---|---|
| GDFT group | Experimental | Patients in the GDFT group were managed perioperatively using goal-directed fluid administration and continuous intravenous analgesia. Receives: Procedure: GDFT |
| GDFT/ED group | Experimental | Patients in the GDFT/ED group were managed perioperatively using goal-directed fluid administration and epidural analgesia. Receives: Procedure: GDFT/ED |
| CFT | Experimental | Patients in the CFT group were managed perioperatively using conventional fluid administration and continuous intravenous analgesia. Receives: Procedure: CFT |
| CFT/ED | Experimental | Patients in the CFT group were managed perioperatively using conventional fluid administration and epidural analgesia. Receives: Procedure: CFT/ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal dysfunction
Postoperative ileus, anastomotic leak, anastomotic breakdown, gastrointestinal bleeding.
Measured: From day of surgery untill 30 days after surgery.
Length of hospital stay
Duration (days) from admission to hospital discharge
Measured: From day of admission to day of discharge, an average of 30 days.
Secondary outcomes (8)
Total fluids
Total volume of fluids administered intraoperatively.
Measured: From beginning of surgery until PACU (post anaesthesia care unit) discharge, an average of 5 hours.
proBNP levels
Measurement of proBNP (pro B-type natriuretic peptide) blood levels at two time points: pre- and postoperatively.
Measured: From 20-24 hours before surgery to 20-24 hours after surgery.
All-cause in hospital mortality
Total number of deaths that occur within a hospital setting, regardless of the underlying cause.
Measured: From day of admission to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Postoperative pulmonary complications
Respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, acute respiratory distress syndrome [ARDS], pulmonary edema, exacerbation of pre-existing lung disease, and pulmonary embolism.
Measured: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Major adverse cardiovascular events
Stroke, myocardial infarction, cardiovascular death
Measured: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Acute kidney injury
Postoperative injury to the kidneys is reflected by at least a twofold increase in baseline serum creatinine.
Measured: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Reoperation
Need for reoperation and return to the theater after PACU (post anaesthesia care unit) discharge.
Measured: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
ICU admission
Unplanned ICU (intensive care medicine) admission after surgery.
Measured: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 May 2017
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly allocated into four groups based on different anesthetic modalities for intraoperative fluid management and analgesic strategy: The GDFT group received goal-directed fluid therapy and continuous intravenous analgesia, the GDFT/ED group received goal-directed fluid therapy and epidural analgesia, the CFT group received conventional fluid administration and continuous intravenous analgesia, and the CFT/ED group received conventional fluid administration and epidural analgesia. Data for the GDFT and GDFT/ED groups were collected prospectively, while data for the CFT and CFT/ED groups were collected retrospectively
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agathi Karakosta, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810648
- Sponsor's protocol ID
- 06-15/09/2016
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 5 Feb 2025
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Analgesia on Goal-Directed Fluid Therapy Using Stroke Volume Variation in Elective Major Abdominal Surgery Involving Low Risk Patients: A Cohort Study
- ClinicalTrials.gov ID
- NCT06810648
- Acronym / sponsor ID
- 06-15/09/2016
- Conditions
- ERAS, Colorectal Surgery, Goal-directed Fluid Therapy, Conventional Fluid Therapy, Epidural Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 5 Feb 2025 (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 have demonstrated their efficacy in expediting recovery and minimizing postoperative complications, especially in patients undergoing abdominal surgery. Perioperative hydration is one of the most critical pillars of the ERAS protocols, with goal-directed methods for administering fluids increasingly incorporated into these protocols.
The Goal-Directed Fluid Therapy (GDFT) method is a strategy used in perioperative and critical care settings to optimize fluid administration tailored to a patient's individual needs. Its goal is to maintain adequate tissue perfusion and oxygenation by precisely balancing fluid administration, avoiding both hypovolemia (too little fluid) and fluid overload. Rather than using a "one-size-fits-all" approach, GDFT adjusts fluid delivery based on real-time monitoring of the patient's physiological parameters. GDFT focuses on dynamic hemodynamic indicators, such as stroke volume (SV), stroke volume variation (SVV), and cardiac output (CO), which provide better insight into the patient's fluid responsiveness. Advanced monitoring tools, such as esophageal Doppler, pulse contour analysis, or invasive devices like a pulmonary artery catheter, are used to assess the patient's response to fluid administration. The implementation of such protocols, particularly in colorectal surgery, has proven beneficial, as both overhydration and underhydration in this context can significantly impair organ function and, consequently, affect patient outcomes. Hypovolemia may lead to tissue ischemia at the anastomotic site, potentially causing breakdown. Conversely, fluid overload can have harmful consequences; hyperhydration may cause tissue edema, thereby reducing anastomotic strength. However, these findings have been validated primarily in high-risk patients, with a limited number of studies involving low- to moderate-risk patients undergoing major abdominal surgery.
Colorectal surgery is routinely managed with epidural analgesia combined with general anaesthesia. However, concerns have been raised that epidurally induced sympathetic blockade and vasoplegia (vasodilation) can cause haemodynamic instability, necessitating fluid and vasopressor administration to an uncertain extent.
In this single-center trial, we aimed to investigate whether epidural analgesia, in addition to general anaesthesia, influences Stroke Volume Variation (SVV)-guided GDFT using the FloTrac/Vigileo monitor during major open abdominal surgery. The study hypothesis was that epidural analgesia may result in fluid overload to compensate for the induced vasoplegia and that this fluid overload, in turn, could lead to gastrointestinal dysfunction and prolong the length of hospital stay.
The primary outcomes were the incidence of postoperative gastrointestinal dysfunction and the length of hospital stay following elective colorectal surgery in patients managed with GDFT, either with or without epidural analgesia. Additionally, patient records of those treated with conventional fluid therapy (CFT), with or without epidural analgesia, were reviewed retrospectively for comparison.
Detailed description
Existing evidence regarding the implementation of Enhanced Recovery After Surgery (ERAS) protocols highlights their benefits in accelerating the recovery process and reducing hospital stay durations. Additionally, postoperative morbidity, mortality, and rehospitalization rates are lower in patients following these protocols. A key component of ERAS protocols is perioperative fluid management, which is critical for gastrointestinal recovery after major abdominal surgery. Both overhydration and underhydration can significantly impair organ function and, consequently, affect patient outcomes.
Goal-directed fluid therapy (GDFT), utilizing dynamic volume measurements, enables balanced fluid administration. Numerous studies support the implementation of such protocols, particularly in major abdominal surgeries. Colonic anastomotic leakage is one of the most serious complications following colorectal surgery, with a reported incidence of up to 20%. Anastomotic breakdown is associated with increased morbidity and mortality, resulting in prolonged hospitalization, depletion of healthcare resources, and elevated costs. Hypovolemia can lead to tissue ischemia at the anastomotic site, causing breakdown. Conversely, fluid overload may have harmful consequences; hyperhydration can lead to tissue edema, thereby reducing anastomotic strength. These findings underscore the importance of maintaining euvolemia during colorectal surgeries, supporting the inclusion of GDFT as an essential component of the anesthetic protocol. However, the benefits of GDFT in abdominal surgery have been predominantly investigated and validated in high-risk patients. Only a limited number of studies involve low- to moderate-risk patients undergoing major abdominal surgery.
Epidural analgesia, combined with general anaesthesia, is considered the gold standard anaesthetic regimen for major abdominal surgery. However, the resulting sympathetic blockade and vasoplegia can cause haemodynamic instability, affecting fluid administration and vasopressor requirements to an uncertain extent. Various clinical and laboratory markers have been employed to monitor the effects of perioperative fluid management. Evidence suggests that B-type Natriuretic Peptide (BNP) levels are associated with fluid balance, morbidity and mortality at 30 days or even 180 days after non-cardiac surgery, and length of hospital stay. However, the concept of using risk predictors such as BNP in surgeries involving significant fluid loss and redistribution, such as colorectal surgeries, remains insufficiently studied.
This single-center trial was conducted to investigate whether epidural analgesia, in addition to general anaesthesia, influences Stroke Volume Variation (SVV) guided GDFT using the FloTrac/Vigileo monitor in major open abdominal surgery. The study hypothesis was that epidural analgesia may result in overhydration to compensate for the induced vasoplegia, thereby affecting gastrointestinal function and length of hospital stay. The primary outcome was the effect of epidural analgesia on the incidence of postoperative gastrointestinal dysfunction and the length of hospital stay in low- to moderate-risk patients undergoing open major abdominal surgery managed with intraoperative GDFT. Secondary outcomes included the total volume of fluids administered, assessment of proBNP levels as a marker of fluid balance, incidence of postoperative adverse events, and all-cause in-hospital mortality. Additionally, patients' records treated with conventional fluid therapy (CFT) with or without epidural analgesia were reviewed retrospectively for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Patients were randomly allocated into four groups based on different anesthetic modalities for intraoperative fluid management and analgesic strategy: The GDFT group received goal-directed fluid therapy and continuous intravenous analgesia, the GDFT/ED group received goal-directed fluid therapy and epidural analgesia, the CFT group received conventional fluid administration and continuous intravenous analgesia, and the CFT/ED group received conventional fluid administration and epidural analgesia. Data for the GDFT and GDFT/ED groups were collected prospectively, while data for the CFT and CFT/ED groups were collected retrospectively
| Arm | Type | Receives |
|---|---|---|
| GDFT group | Experimental | Procedure: GDFTPatients in the GDFT group were managed perioperatively using goal-directed fluid administration and continuous intravenous analgesia. |
| GDFT/ED group | Experimental | Procedure: GDFT/EDPatients in the GDFT/ED group were managed perioperatively using goal-directed fluid administration and epidural analgesia. |
| CFT | Experimental | Procedure: CFTPatients in the CFT group were managed perioperatively using conventional fluid administration and continuous intravenous analgesia. |
| CFT/ED | Experimental | Procedure: CFT/EDPatients in the CFT group were managed perioperatively using conventional fluid administration and epidural analgesia. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults
- elective oncological colorectal surgery
- ASA (American Society of Anesthesiologists physical status classification) I \& II
Key exclusion criteria (8 listed)
- extremes of weight (< 55 kg or > 120 kg)
- known history of arrhythmias
- recent unstable coronary syndrome
- decompensated heart failure
- severe aortic valve stenosis
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 |
|---|---|---|
| GDFTAlso: Prospective groupHydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was provided with intravenous analgesics. | Procedure or surgery | GDFT group |
| GDFT/EDAlso: Prospective groupHydration was goal-directed and guided by Stroke Volume Variation (SVV) using the FloTrac/Vigileo monitor, while analgesia was administered via epidural analgesics. | Procedure or surgery | GDFT/ED group |
| CFTAlso: Retrospective groupPatients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was provided with intravenous analgesics. | Procedure or surgery | CFT |
| CFT/EDAlso: Retrospective groupPatients received conventional fluid therapy (based on heart rate, urine output and mean arterial pressure) and analgesia was administered via epidural analgesics. | Procedure or surgery | CFT/ED |
Primary outcome
Gastrointestinal dysfunction
Time frame: From day of surgery untill 30 days after surgery.
Postoperative ileus, anastomotic leak, anastomotic breakdown, gastrointestinal bleeding.
Length of hospital stay
Time frame: From day of admission to day of discharge, an average of 30 days.
Duration (days) from admission to hospital discharge
8 secondary outcomes
Total fluids
Time frame: From beginning of surgery until PACU (post anaesthesia care unit) discharge, an average of 5 hours.
proBNP levels
Time frame: From 20-24 hours before surgery to 20-24 hours after surgery.
All-cause in hospital mortality
Time frame: From day of admission to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Postoperative pulmonary complications
Time frame: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Major adverse cardiovascular events
Time frame: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Acute kidney injury
Time frame: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Reoperation
Time frame: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
ICU admission
Time frame: From day of surgery to day of discharge from the hospital or day of death during hospitalization, whichever comes first, an average of 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDFT, GDFT/ED and CFT in people with ERAS and Colorectal Surgery, run by University of Ioannina at 2 sites in Greece.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal dysfunction (time frame: From day of surgery untill 30 days after surgery.). 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 5 Feb 2025.