Colorectal ResectionNCT02036346
Electrolyte Profile, Nutritional Status and Ileostomy Formation.
A study testing Oral Ηydration Solution, Advise on calculated oral fluid requirements and No nutritional advice will be given in people with Colorectal Resection and Ileostomy, run by Larissa University Hospital at 1 site in Greece.
Trial summary
One of the main reasons for hospital readmission in ileostomy patients is fluid and electrolyte abnormalities. Prospective observational studies have suggested an occurrence rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium and fluid through their stoma effluent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Resection, Ileostomy
- What is being tested?
- Oral Ηydration Solution, Advise on calculated oral fluid requirements and No nutritional advice will be given
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2013to Jan 2018
- 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
- Male of female patients of more than 18 years of age
- Patients who have undergone a rectosigmoidectomy procedure resulting or not in an ileostomy formation
Who cannot join
- Short Bowel Syndrome
- Diabetic ketoacidosis
- Chronic Renal failure
- Hepatic/Cardiac failure
- Diabetes insipidus
- Diuretic Medication
- Corticosteroid Medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ileostomy Formation on Nutritional Status and Electrolyte Profile in Rectosigmoidectomy Patients: a Prospective Randomized Trial.
One of the main reasons for hospital readmission in ileostomy patients is fluid and electrolyte abnormalities. Prospective observational studies have suggested an occurrence rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium and fluid through their stoma effluent. In addition studies have shown that ileostomy construction is a risk factor for renal impairment, occurring secondary to dehydration.
Encouraging patients to increase total fluid intake seems to be a common mistake in clinical practice as this can dilute sodium levels even more, causing greater sodium depletion. In terms of addressing the problem a few small studies have used isotonic drinks of various compositions showing increased electrolyte absorption.
Read more
Other dietary complications sometimes include hypomagnesaemia and decreased absorption of B-12 and folic acid, however due to the integrity of the small intestine other nutrient malabsorption is unlikely to occur. As far as body composition is concerned obesity has been shown to be a risk factor for peri- and postoperative complications in colorectal surgery (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining measures that can prevent readmission for dehydration and other nutritional considerations related to this group of patients is definitely required.
Hypothesis:
The administration of an oral rehydration solution will allow a significant decrease in dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.
- Conditions
- Colorectal Resection, Ileostomy
- Being tested
- Oral Ηydration Solution, Advise on calculated oral fluid requirements, No nutritional advice will be given
- Keywords
- ileostomy, colorectal resection, dehydration, nutritional status
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Ηydration SolutionDietary supplement
Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water.
Advise on calculated oral fluid requirementsOther
No nutritional advice will be givenOther
| Study group | Role | What they receive |
|---|---|---|
| Oral rehydration solution | Experimental | Patients who have undergone colorectal resection surgery resulting in an ileostomy creation Receives: Dietary Supplement: Oral Ηydration Solution |
| No intervention | Experimental | Patients who have undergone colorectal resection surgery resulting in an ileostomy creation Receives: Other: Advise on calculated oral fluid requirements |
| Colorectal resection without an ileostomy | Active comparator | Patients who have undergone colorectal resection surgery without an ileostomy creation Receives: Other: No nutritional advice will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum electrolyte levels
sodium (mmol/l)
Measured: up to 20-40 days postoperatively
Serum electrolyte levels
potassium (mmol/l)
Measured: up to 20-40 days postoperatively
Serum electrolyte levels
magnesium (mg/dl)
Measured: up to 20-40 days postoperatively
Serum electrolyte levels
chloride (mmol/l)
Measured: up to 20-40 days postoperatively
Secondary outcomes (11)
Physical findings of dehydration
thirst, dizziness, lethargy, oliguria, dense urine
Measured: 20 days postoperatively, 40 days postoperatively
Biochemical markers reflecting dehydration and renal function
Urea (mg/dl)
Measured: 20 days postoperativey, 40 days postoperatively
Biochemical markers reflecting dehydration and renal function
Creatinine (mg/dl)
Measured: 20 days postoperativey, 40 days postoperatively
Anthropometric characteristics
weight (kg)
Measured: baseline, 40 days postoperatively
Anthropometric characteristics
height (m)
Measured: baseline, 40 days postoperatively
Anthropometric characteristics
BMI (kg/m2)
Measured: baseline, 40 days postoperatively
Anthropometric characteristics
total body fat (%)
Measured: baseline, 40 days postoperatively
Nutritional Intake
Energy intake assessed through 24hour recalls and analyzed via nutrition analysis software
Measured: baseline, at 20 days and 40 days postoperatively
Nutritional Intake
Macronutrient intake assessed through 24hour recalls and analyzed via nutrition analysis software
Measured: baseline, at 20 days and 40 days postoperatively
Nutritional Intake
Electrolyte intake via diet assessed through 24hour recalls and analyzed via nutrition analysis software
Measured: baseline, at 20 days and 40 days postoperatively
Stoma output (ml/L)
Measured: baseline, at 20 days and 40 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal ResectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, ATHANASIOS MIGDANIS, Larissa University Hospital
- Investigators
- GEORGE TZOVARAS, MD, Study chair, University Hospital of LarissaGEORGE TZOVARAS, MD, Study director, University Hopsital of LarissaGeorgios D Koukoulis, M.D. MSc PhD, Principal investigator, Department of General Surgery, University Hospital of Larisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036346
- Sponsor's protocol ID
- LarissaUH
- Status last verified
- Jul 2018
- First submitted
- 30 Dec 2013
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Kanaki M, Malissiova E, Tzovaras G. Administration of an Oral Hydration Solution Prevents Electrolyte and Fluid Disturbances and Reduces Readmissions in Patients With a Diverting Ileostomy After Colorectal Surgery: A Prospective, Randomized, Controlled Trial. Dis Colon Rectum. 2018 Jul;61(7):840-846. doi: 10.1097/DCR.0000000000001082.
PubMed 29771807Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Vagena X, Malissiova E, Tzovaras G. The effect of a diverting ileostomy formation on nutritional status and energy intake of patients undergoing colorectal surgery. Clin Nutr ESPEN. 2020 Dec;40:357-362. doi: 10.1016/j.clnesp.2020.08.002. Epub 2020 Aug 28.
PubMed 33183563
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ileostomy Formation on Nutritional Status and Electrolyte Profile in Rectosigmoidectomy Patients: a Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT02036346
- Acronym / sponsor ID
- LarissaUH
- Conditions
- Colorectal Resection, Ileostomy
- Keywords
- ileostomy, colorectal resection, dehydration, nutritional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 15 Jan 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.
One of the main reasons for hospital readmission in ileostomy patients is fluid and electrolyte abnormalities. Prospective observational studies have suggested an occurrence rate of around 20%. Due to colonic exclusion ileostomy patients lose large amounts of sodium and fluid through their stoma effluent. In addition studies have shown that ileostomy construction is a risk factor for renal impairment, occurring secondary to dehydration.
Encouraging patients to increase total fluid intake seems to be a common mistake in clinical practice as this can dilute sodium levels even more, causing greater sodium depletion. In terms of addressing the problem a few small studies have used isotonic drinks of various compositions showing increased electrolyte absorption.
Other dietary complications sometimes include hypomagnesaemia and decreased absorption of B-12 and folic acid, however due to the integrity of the small intestine other nutrient malabsorption is unlikely to occur. As far as body composition is concerned obesity has been shown to be a risk factor for peri- and postoperative complications in colorectal surgery (e.g. peristomal dermatitis, stoma stenosis and prolapse). A prospective trial examining measures that can prevent readmission for dehydration and other nutritional considerations related to this group of patients is definitely required.
Hypothesis:
The administration of an oral rehydration solution will allow a significant decrease in dehydration and electrolyte abnormality rates in patients with a temporary ileostomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral rehydration solution | Experimental | Dietary Supplement: Oral Ηydration SolutionPatients who have undergone colorectal resection surgery resulting in an ileostomy creation |
| No intervention | Experimental | Other: Advise on calculated oral fluid requirementsPatients who have undergone colorectal resection surgery resulting in an ileostomy creation |
| Colorectal resection without an ileostomy | Active comparator | Other: No nutritional advice will be givenPatients who have undergone colorectal resection surgery without an ileostomy creation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male of female patients of more than 18 years of age
- Patients who have undergone a rectosigmoidectomy procedure resulting or not in an ileostomy formation
Key exclusion criteria (7 listed)
- Short Bowel Syndrome
- Diabetic ketoacidosis
- Chronic Renal failure
- Hepatic/Cardiac failure
- Diabetes insipidus
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 |
|---|---|---|
| Oral Ηydration SolutionOral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water. | Dietary supplement | Oral rehydration solution |
| Advise on calculated oral fluid requirements | Other | No intervention |
| No nutritional advice will be given | Other | Colorectal resection without an ileostomy |
Primary outcome
Serum electrolyte levels
Time frame: up to 20-40 days postoperatively
sodium (mmol/l)
Serum electrolyte levels
Time frame: up to 20-40 days postoperatively
potassium (mmol/l)
Serum electrolyte levels
Time frame: up to 20-40 days postoperatively
magnesium (mg/dl)
Serum electrolyte levels
Time frame: up to 20-40 days postoperatively
chloride (mmol/l)
11 secondary outcomes
Physical findings of dehydration
Time frame: 20 days postoperatively, 40 days postoperatively
Biochemical markers reflecting dehydration and renal function
Time frame: 20 days postoperativey, 40 days postoperatively
Biochemical markers reflecting dehydration and renal function
Time frame: 20 days postoperativey, 40 days postoperatively
Anthropometric characteristics
Time frame: baseline, 40 days postoperatively
Anthropometric characteristics
Time frame: baseline, 40 days postoperatively
Anthropometric characteristics
Time frame: baseline, 40 days postoperatively
Anthropometric characteristics
Time frame: baseline, 40 days postoperatively
Nutritional Intake
Time frame: baseline, at 20 days and 40 days postoperatively
Nutritional Intake
Time frame: baseline, at 20 days and 40 days postoperatively
Nutritional Intake
Time frame: baseline, at 20 days and 40 days postoperatively
Stoma output (ml/L)
Time frame: baseline, at 20 days and 40 days postoperatively
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 3 Jul 2018.
- Background: PubMed 29771807Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Kanaki M, Malissiova E, Tzovaras G. Administration of an Oral Hydration Solution Prevents Electrolyte and Fluid Disturbances and Reduces Readmissions in Patients With a Diverting Ileostomy After Colorectal Surgery: A Prospective, Randomized, Controlled Trial. Dis Colon Rectum. 2018 Jul;61(7):840-846. doi: 10.1097/DCR.0000000000001082.
- Derived from this study: PubMed 33183563Migdanis A, Koukoulis G, Mamaloudis I, Baloyiannis I, Migdanis I, Vagena X, Malissiova E, Tzovaras G. The effect of a diverting ileostomy formation on nutritional status and energy intake of patients undergoing colorectal surgery. Clin Nutr ESPEN. 2020 Dec;40:357-362. doi: 10.1016/j.clnesp.2020.08.002. Epub 2020 Aug 28.
- Related InfoLink provided by the sponsor.
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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.
GEORGE TZOVARAS, MD study chair
University Hospital of Larissa
GEORGE TZOVARAS, MD study director
University Hopsital of Larissa
Georgios D Koukoulis, M.D. MSc PhD principal investigator
Department of General Surgery, University Hospital of Larisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Ηydration Solution, Advise on calculated oral fluid requirements and No nutritional advice will be given in people with Colorectal Resection and Ileostomy, run by Larissa University Hospital at 1 site 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 2 inclusion and 7 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 3 Jul 2018. 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 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?
Serum electrolyte levels (time frame: up to 20-40 days postoperatively). The study lists 4 primary outcomes in all. 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 NCT02036346, which also lists 2 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 3 Jul 2018.