Postoperative ComplicationsPhase 4NCT02313519
Probiotics in the Prevention of Complications After Colorectal Surgery
A Phase 4 study testing Probiotics in people with Postoperative Complications, run by Evangelos J. Giamarellos-Bourboulis, M.D..
Trial summary
Based on the need of large-scale, trials to explore the use of probiotics to reduce post-operative complication rate, a randomized controlled trial is designed to investigate the impact of a probiotics treatment protocol on postoperative morbidity in an open elective colonic surgery cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Aug 2014
- Phase
- Phase 4
- 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
- Written informed consent
- Acceptable nutritional status and programmed for open surgery for colorectal cancer.
- Operation by the same consultant either as surgeon or as the primary assistant.
Who cannot join
- Inability to provide written informed consent
- The need only for emergency or palliative surgery
- American Society of Anaesthesiologists (ASA) class of IV
- Pregnancy or lactation
- Inflammatory bowel disease
- Use of antibiotics during the last 10 days before surgery
- Recent steroid therapy or preoperative neoadjuvant chemotherapy or radiotherapy
- Pre-existing signs of bacterial [white cell count, body temperature] or viral infection [hepatitis B or C, human immunodeficiency virus, cytomegalovirus].
About this study
Official title: A Randomized Clinical Study of the Efficacy of a Formulation of Four Probiotics for the Prevention of Post-operative Complications in Patients Undergoing Colorectal Surgery
Based on the need of large-scale, trials to explore the use of probiotics to reduce post-operative complication rate, a randomized controlled trial is designed to investigate the impact of a probiotics treatment protocol on postoperative morbidity in an open elective colonic surgery cohort. The major objective is reduction of post-operative complications after 30 days.
Read the detailed description
Major colorectal surgery, i.e. surgery involving a wide colon resection and/or a very low anastomosis, remains problematic, despite great advances in medico-pharmaceutical treatment, improvement in surgical techniques, and sophisticated postoperative management. Such surgery is still accompanied by an unacceptably high morbidity of 15% to 23.2% leading to an increase in the number of ventilatory support days, prolongation of total hospital stay, significantly higher medical costs, patient suffering, and, unfortunately mortality. Worse than this, nowadays, infections and sepsis are by far the most common morbidities, either as initial cause or as a consequence of another complication, such as anastomotic leakage. Ongoing clinical studies have reported probiotic therapies to be beneficial in elective surgery cases, since they have been shown to successfully modulate the GI flora in a plethora of medical settings and in critically ill and trauma patients. More precisely, recent randomized controlled studies and meta-analyses in elective surgery and abdominal surgery patients have demonstrated that the perioperative use of probiotics is safe and reduces both the incidence of postoperative wound infections, sepsis, post-operative pneumonia and other infections, and the necessary duration of hospital stay and length of antibiotic therapy. However, there exist few controlled, large-scale, trials comparing the current standard treatment with the probiotic concept and showing the superiority of the latter in colonic surgery with regard to a reduced complication rate. Therefore, the investigators decided to conduct a randomized controlled trial to investigate the impact of a probiotics treatment protocol on postoperative morbidity in an open elective colonic surgery cohort. The major objective is to evidence a reduction in 30-day infectious, surgery-related morbidity: any surgical site infection; organ specific infections; systemic infections and anastomotic leakage. Minor objectives related to the reduction in other non-infectious complications, as well as the assessment of outcome indicators such as the number of days in postoperative ileus, on mechanical ventilation, stay in ICU, total hospitalization and mortality in the 30-day post-operative period.
- Conditions
- Postoperative Complications
- Being tested
- Probiotics, Placebo
- Keywords
- Infections, anastomotic leakage
- Medical subject headings
- Postoperative Complications, Infections, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Lactobacillus, Bifidobacterium and Saccharomyces boulardii
Probiotics are prepared in capsule form
PlaceboDietary supplement
Also called Placebo capsules
Glucose powder
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules of powdered glucose polymer given one capsule every 12 hours for 15 days Receives: Dietary Supplement: Placebo |
| Probiotics | Active comparator | Capsules containing Lactobacillus acidophilus LA-5 [1.75x10^9 cfu], Lactobacillus plantarum [0.5x10^9 cfu], Bifidobacterium lactis BB-12 [1.75x10^9cfu], and Saccharomyces boulardii [1.5x10^9] per capsule. One capsule is given every 12 hours for 15 days Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The total of postoperative complications observes in each study group. These comprise: any anastomotic leakage; abdominal wound infection and dehiscence; organ specific infections, such as pneumonia, urinary tract and central vein port-site infections, and systemic infections [bacteraemia, fungal infections] as regularly defined by positive cultures, radiograms, increased white blood cell count or purulent material discharge; sepsis and septic shock
Measured: 30 days
Secondary outcomes (3)
Minor complications
Rate of minor events in each group. These comprise peripheral vein thrombosis or pulmonary embolism and cardio-pulmonary or renal insufficiency. Moreover, the number of days on mechanical ventilation, in postoperative ileus, of total hospitalization, as well as 30-day mortality is taken into account.
Measured: 30 days
Cytokine levels
Measurement of serum cytokines in subgroups of patients
Measured: 4 days
Cytokine gene transcripts
Measurement of gene transcripts in whole blood in subgroups of patients
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelos J. Giamarellos-Bourboulis, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Sponsor-investigator, Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens
- Investigators
- Katerina Kotxampassi, MD, PhD, Study chair, AXEPA University of Thessaloniki, 1st Department of Propedeutic Surgery, Thessaloniki, GreeceEvangelos Giamarellos-Bourboulis, MD, PhD, Principal investigator, University of Athens, 4th Department of Internal Medicine, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313519
- Sponsor's protocol ID
- LACT002
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2014
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giamarellos-Bourboulis EJ, Bengmark S, Kanellakopoulou K, Kotzampassi K. Pro- and synbiotics to control inflammation and infection in patients with multiple injuries. J Trauma. 2009 Oct;67(4):815-21. doi: 10.1097/TA.0b013e31819d979e.
PubMed 19820590Kotzampassi K, Giamarellos-Bourboulis EJ, Voudouris A, Kazamias P, Eleftheriadis E. Benefits of a synbiotic formula (Synbiotic 2000Forte) in critically Ill trauma patients: early results of a randomized controlled trial. World J Surg. 2006 Oct;30(10):1848-55. doi: 10.1007/s00268-005-0653-1.
PubMed 16983476Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.
PubMed 25894405
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of the Efficacy of a Formulation of Four Probiotics for the Prevention of Post-operative Complications in Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02313519
- Acronym / sponsor ID
- LACT002
- Conditions
- Postoperative Complications
- Keywords
- Infections, anastomotic leakage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Evangelos J. Giamarellos-Bourboulis, M.D.University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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.
Based on the need of large-scale, trials to explore the use of probiotics to reduce post-operative complication rate, a randomized controlled trial is designed to investigate the impact of a probiotics treatment protocol on postoperative morbidity in an open elective colonic surgery cohort. The major objective is reduction of post-operative complications after 30 days.
Detailed description
Major colorectal surgery, i.e. surgery involving a wide colon resection and/or a very low anastomosis, remains problematic, despite great advances in medico-pharmaceutical treatment, improvement in surgical techniques, and sophisticated postoperative management. Such surgery is still accompanied by an unacceptably high morbidity of 15% to 23.2% leading to an increase in the number of ventilatory support days, prolongation of total hospital stay, significantly higher medical costs, patient suffering, and, unfortunately mortality. Worse than this, nowadays, infections and sepsis are by far the most common morbidities, either as initial cause or as a consequence of another complication, such as anastomotic leakage. Ongoing clinical studies have reported probiotic therapies to be beneficial in elective surgery cases, since they have been shown to successfully modulate the GI flora in a plethora of medical settings and in critically ill and trauma patients. More precisely, recent randomized controlled studies and meta-analyses in elective surgery and abdominal surgery patients have demonstrated that the perioperative use of probiotics is safe and reduces both the incidence of postoperative wound infections, sepsis, post-operative pneumonia and other infections, and the necessary duration of hospital stay and length of antibiotic therapy. However, there exist few controlled, large-scale, trials comparing the current standard treatment with the probiotic concept and showing the superiority of the latter in colonic surgery with regard to a reduced complication rate. Therefore, the investigators decided to conduct a randomized controlled trial to investigate the impact of a probiotics treatment protocol on postoperative morbidity in an open elective colonic surgery cohort. The major objective is to evidence a reduction in 30-day infectious, surgery-related morbidity: any surgical site infection; organ specific infections; systemic infections and anastomotic leakage. Minor objectives related to the reduction in other non-infectious complications, as well as the assessment of outcome indicators such as the number of days in postoperative ileus, on mechanical ventilation, stay in ICU, total hospitalization and mortality in the 30-day post-operative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules of powdered glucose polymer given one capsule every 12 hours for 15 days |
| Probiotics | Active comparator | Dietary Supplement: ProbioticsCapsules containing Lactobacillus acidophilus LA-5 [1.75x10^9 cfu], Lactobacillus plantarum [0.5x10^9 cfu], Bifidobacterium lactis BB-12 [1.75x10^9cfu], and Saccharomyces boulardii [1.5x10^9] per capsule. One capsule is given every 12 hours for 15 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Acceptable nutritional status and programmed for open surgery for colorectal cancer.
- Operation by the same consultant either as surgeon or as the primary assistant.
Key exclusion criteria (8 listed)
- Inability to provide written informed consent
- The need only for emergency or palliative surgery
- American Society of Anaesthesiologists (ASA) class of IV
- Pregnancy or lactation
- Inflammatory bowel disease
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 |
|---|---|---|
| ProbioticsAlso: Lactobacillus, Bifidobacterium and Saccharomyces boulardiiProbiotics are prepared in capsule form | Dietary supplement | Probiotics |
| PlaceboAlso: Placebo capsulesGlucose powder | Dietary supplement | Placebo |
Primary outcome
Postoperative complications
Time frame: 30 days
The total of postoperative complications observes in each study group. These comprise: any anastomotic leakage; abdominal wound infection and dehiscence; organ specific infections, such as pneumonia, urinary tract and central vein port-site infections, and systemic infections [bacteraemia, fungal infections] as regularly defined by positive cultures, radiograms, increased white blood cell count or purulent material discharge; sepsis and septic shock
3 secondary outcomes
Minor complications
Time frame: 30 days
Cytokine levels
Time frame: 4 days
Cytokine gene transcripts
Time frame: 4 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 10 Dec 2014.
- Background: PubMed 19820590Giamarellos-Bourboulis EJ, Bengmark S, Kanellakopoulou K, Kotzampassi K. Pro- and synbiotics to control inflammation and infection in patients with multiple injuries. J Trauma. 2009 Oct;67(4):815-21. doi: 10.1097/TA.0b013e31819d979e.
- Background: PubMed 16983476Kotzampassi K, Giamarellos-Bourboulis EJ, Voudouris A, Kazamias P, Eleftheriadis E. Benefits of a synbiotic formula (Synbiotic 2000Forte) in critically Ill trauma patients: early results of a randomized controlled trial. World J Surg. 2006 Oct;30(10):1848-55. doi: 10.1007/s00268-005-0653-1.
- Derived from this study: PubMed 25894405Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.
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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.
Katerina Kotxampassi, MD, PhD study chair
AXEPA University of Thessaloniki, 1st Department of Propedeutic Surgery, Thessaloniki, Greece
Evangelos Giamarellos-Bourboulis, MD, PhD principal investigator
University of Athens, 4th Department of Internal Medicine, Athens, Greece
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotics in people with Postoperative Complications, run by Evangelos J. Giamarellos-Bourboulis, M.D..
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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02313519, which also lists 3 linked publications.
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 10 Dec 2014.