Colorectal CancerOPTI-NUTRICSNCT06737211
Optimizing Postoperative Nutrition in Colorectal Surgery
A study testing Peripheral Parenteral Nutrition in people with Colorectal Cancer and Inflammatory Bowel Diseases, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Colorectal Cancer, Inflammatory Bowel Diseases, Bowel Ischemia
- What is being tested?
- Peripheral Parenteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2024to 20 Nov 2025
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal resection surgery
- Open or laparoscopic procedures
- Anastomosis, end-stoma or defunctioning stoma formation after colorectal resection
- Elective or emergent procedures
- Diagnosis of colorectal cancer, inflammatory bowel disease, diverticular disease and bowel ischemia
- Small bowel resection combined with colorectal resection
- Age > 18 years old
- Informed consent
Who cannot join
- Small bowel resection without colorectal resection
- End-stoma or defunctioning stoma formation without colorectal resection
- Preoperative parenteral nutrition administration
- Administration of parenteral nutrition after the 4th postoperative day
- Peripheral parenteral nutrition initiation after the 1st postoperative day
- Contraindication for peripheral parenteral nutrition administration
- Age < 18 years old
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Postoperative Nutrition in Colorectal Surgery: a Prospective Randomized Clinical Trial.
Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. Therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. However, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. The energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. However, the conventional way of administration through central venous lines is associated with significant complications. For this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. Therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. Moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.
- Conditions
- Colorectal Cancer, Inflammatory Bowel Diseases, Bowel Ischemia, Malnutrition, Parenteral Nutrition
- Being tested
- Peripheral Parenteral Nutrition
- Keywords
- peripheral parenteral nutrition, postoperative outcomes, colorectal surgery, colorectal cancer, inflammatory bowel disease, bowel ischemia
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases, Malnutrition, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Parenteral NutritionDietary supplement
2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day Receives: Dietary Supplement: Peripheral Parenteral Nutrition |
| Control | No intervention | 1000 mL of 10% glucose saline with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a central or peripheral venous catheter with a rhythm of 80cc/h until the 5th postoperative day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Surgical Stress and Short-term Nutritional Status
Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response.
Measured: 5 postoperative days
Secondary outcomes (6)
Postoperative Morbidity
Complications after surgery and their classification according to Calvin-Dindo score.
Measured: 90 postoperative days
Nasogastric tube removal
Postoperative day of nasogastric tube removal
Measured: 30 postoperative days
Feeding start
Postoperative day of feeding start
Measured: 30 postoperative days
Early mobilization
Postoperative day of mobilization
Measured: 30 postoperative days
Opioid sparing analgesia
Utilization of epidural sparing catheter
Measured: 30 postoperative days
Peripheral Parenteral Nutrition - associated complications
Thrombophlebitis, hyperglycemia, re-feeding syndrome
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Dec 2024
- Primary completion20 Aug 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximos Frountzas, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737211
- Sponsor's protocol ID
- OPTI-NUTRICS study
- Acronym
- OPTI-NUTRICS
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Studer P, Raber G, Ott D, Candinas D, Schnuriger B. Risk factors for fatal outcome in surgical patients with postoperative aspiration pneumonia. Int J Surg. 2016 Mar;27:21-25. doi: 10.1016/j.ijsu.2016.01.043. Epub 2016 Jan 20.
PubMed 26804349Herbert G, Perry R, Andersen HK, Atkinson C, Penfold C, Lewis SJ, Ness AR, Thomas S. Early enteral nutrition within 24 hours of lower gastrointestinal surgery versus later commencement for length of hospital stay and postoperative complications. Cochrane Database Syst Rev. 2019 Jul 22;7(7):CD004080. doi: 10.1002/14651858.CD004080.pub4.
PubMed 31329285Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, Thevathasan T, Pieretti A, Ferrone C, Hoeft A, Scheeren TWL, Thompson BT, Kurth T, Eikermann M. Effects of Intraoperative Fluid Management on Postoperative Outcomes: A Hospital Registry Study. Ann Surg. 2018 Jun;267(6):1084-1092. doi: 10.1097/SLA.0000000000002220.
PubMed 28288059Cardinale F, Chinellato I, Caimmi S, Peroni DG, Franceschini F, Miraglia Del Giudice M, Bernardini R. Perioperative period: immunological modifications. Int J Immunopathol Pharmacol. 2011 Jul-Sep;24(3 Suppl):S3-12. doi: 10.1177/03946320110240s302.
PubMed 22014920Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.
PubMed 26248016Frountzas M, Mela E, Stefanoudakis D, Theodorou P, Gkotsi I, Linardoutsos D, Triantafyllou T, Chamzin A, Manouras I, Smparounis S, Memos N, Theodorou D, Theodoropoulos G, Toutouzas K. Peripheral parenteral nutrition improves short-term nutritional status and inflammatory reaction after colorectal resection surgery: A randomized clinical trial. Surgery. 2026 Jul 18;198:110458. doi: 10.1016/j.surg.2026.110458. Online ahead of print.
PubMed 42561639
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Postoperative Nutrition in Colorectal Surgery: a Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06737211
- Acronym / sponsor ID
- OPTI-NUTRICS / OPTI-NUTRICS study
- Conditions
- Colorectal Cancer, Inflammatory Bowel Diseases, Bowel Ischemia, Malnutrition, Parenteral Nutrition
- Keywords
- peripheral parenteral nutrition, postoperative outcomes, colorectal surgery, colorectal cancer, inflammatory bowel disease, bowel ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 17 Dec 2024 (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.
Major surgical operations of the gastrointestinal tract, such as colorectal resections due to several diseases, lead to significant burden on the human body, which is expressed during the first postoperative hours with an intense inflammatory reaction and consumption of a large amount of energy, increasing nutritional requirements of the patients. Therefore, specific protocols have been implemented for the early initiation of oral feeding in patients undergoing colorectal resections. However, it is not feasible for every patient to meet them due to several reasons, such as old age and associated pathophysiological changes, use of opioid drugs for the management of postoperative pain, which is associated with postoperative ileus or nausea, as well as open resection which lead to gastrointestinal impairment during the first postoperative days. The energy deficit that occurs during the early postoperative period, which appears to be associated with adverse clinical outcomes, can be counterbalanced by the administration of parenteral nutrition. However, the conventional way of administration through central venous lines is associated with significant complications. For this reason, administration of parenteral nutrition through a peripheral venous catheter could be used alternatively, which avoids morbidity and has been also effective in maintaining the patients' energy balance, even during the first postoperative hours. Therefore, the main purpose of the present study is to investigate the efficacy of the administration of peripheral parenteral nutrition on the postoperative outcomes of patients undergoing colorectal resections. Moreover, the correlation of the administration of peripheral parenteral nutrition with the reaction to post-operative stress and with the nutritional status of the patients post-operatively, which are determining factors for the clinical course of these patients, will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Peripheral Parenteral Nutrition2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day |
| Control | No intervention | –1000 mL of 10% glucose saline with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a central or peripheral venous catheter with a rhythm of 80cc/h until the 5th postoperative day |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Colorectal resection surgery
- Open or laparoscopic procedures
- Anastomosis, end-stoma or defunctioning stoma formation after colorectal resection
- Elective or emergent procedures
- Diagnosis of colorectal cancer, inflammatory bowel disease, diverticular disease and bowel ischemia
Key exclusion criteria (8 listed)
- Small bowel resection without colorectal resection
- End-stoma or defunctioning stoma formation without colorectal resection
- Preoperative parenteral nutrition administration
- Administration of parenteral nutrition after the 4th postoperative day
- Peripheral parenteral nutrition initiation after the 1st postoperative day
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 |
|---|---|---|
| Peripheral Parenteral Nutrition2000 mL of peripheral parenteral nutrition with electrolytes (20 mL 7.45% KCl, 10 mL 20% MgSO4 and 20 mL 8.7% Na3PO4) will be administered via a peripheral venous catheter with a rhythm of 80cc/h from the time they will leave the operation room and will be transferred to the ward or the critical care unit (CCU) until the 5th postoperative day | Dietary supplement | Intervention |
Primary outcome
Postoperative Surgical Stress and Short-term Nutritional Status
Time frame: 5 postoperative days
Serum nutritional markers and acute phase proteins indicating postoperative surgical stress response.
6 secondary outcomes
Postoperative Morbidity
Time frame: 90 postoperative days
Nasogastric tube removal
Time frame: 30 postoperative days
Feeding start
Time frame: 30 postoperative days
Early mobilization
Time frame: 30 postoperative days
Opioid sparing analgesia
Time frame: 30 postoperative days
Peripheral Parenteral Nutrition - associated complications
Time frame: 30 postoperative 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 6 Jan 2026.
- Background: PubMed 26804349Studer P, Raber G, Ott D, Candinas D, Schnuriger B. Risk factors for fatal outcome in surgical patients with postoperative aspiration pneumonia. Int J Surg. 2016 Mar;27:21-25. doi: 10.1016/j.ijsu.2016.01.043. Epub 2016 Jan 20.
- Background: PubMed 31329285Herbert G, Perry R, Andersen HK, Atkinson C, Penfold C, Lewis SJ, Ness AR, Thomas S. Early enteral nutrition within 24 hours of lower gastrointestinal surgery versus later commencement for length of hospital stay and postoperative complications. Cochrane Database Syst Rev. 2019 Jul 22;7(7):CD004080. doi: 10.1002/14651858.CD004080.pub4.
- Background: PubMed 28288059Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, Thevathasan T, Pieretti A, Ferrone C, Hoeft A, Scheeren TWL, Thompson BT, Kurth T, Eikermann M. Effects of Intraoperative Fluid Management on Postoperative Outcomes: A Hospital Registry Study. Ann Surg. 2018 Jun;267(6):1084-1092. doi: 10.1097/SLA.0000000000002220.
- Background: PubMed 22014920Cardinale F, Chinellato I, Caimmi S, Peroni DG, Franceschini F, Miraglia Del Giudice M, Bernardini R. Perioperative period: immunological modifications. Int J Immunopathol Pharmacol. 2011 Jul-Sep;24(3 Suppl):S3-12. doi: 10.1177/03946320110240s302.
- Background: PubMed 26248016Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.
- Derived from this study: PubMed 42561639Frountzas M, Mela E, Stefanoudakis D, Theodorou P, Gkotsi I, Linardoutsos D, Triantafyllou T, Chamzin A, Manouras I, Smparounis S, Memos N, Theodorou D, Theodoropoulos G, Toutouzas K. Peripheral parenteral nutrition improves short-term nutritional status and inflammatory reaction after colorectal resection surgery: A randomized clinical trial. Surgery. 2026 Jul 18;198:110458. doi: 10.1016/j.surg.2026.110458. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Parenteral Nutrition in people with Colorectal Cancer and Inflammatory Bowel Diseases, run by National and Kapodistrian University of Athens 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 8 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 6 Jan 2026. 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?
Postoperative Surgical Stress and Short-term Nutritional Status (time frame: 5 postoperative 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 NCT06737211, which also lists 6 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 6 Jan 2026.