Parenteral NutritionNCT06573632
Perioperative TPN Improves Surgical Outcomes
An observational study of Parenteral Nutrition and Major Surgery, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
Trial summary
Preoperative optimization of patients is a well known concept. Not all patients can tolerate feeds and as such TPN is given. TPN given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parenteral Nutrition, Major Surgery, Malnutrition
- What is being tested?
- TPN-N7 Baxter
- How many people
- 150 participants
- Where
- 1 siteNepal
- Study dates
- 1 Oct 2022to 1 Jan 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presenting to the Surgery department at Nepal Medical College teaching hospital and having malnutrition.
Who may be able to join
- 1. All patients who underwent major gastrointestinal surgery and received perioperative TPN or postoperative TPN
Who cannot join
- Perioperative TPN administration that did not follow the study protocol
- TPN given for reasons other than malnutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Perioperative Parenteral Nutrition Affect Outcome in Patients Undergoing Major Abdominal Surgeries
Preoperative optimization of patients is a well known concept. Not all patients can tolerate feeds and as such TPN is given. TPN given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. So the investigators aim to find the impact of TPN in malnutritional surgical patients.
Read the detailed description
Any patient who is at risk of malnutrition as well as already malnutritioned were given preoperative TPN for 5 days. After 5 days, elective surgery was done and TPN was continued postoperatively until patient could consume 50% of their daily requirements orally. Patients who underwent emergency surgeries were also enrolled in this study as these patients could receive TPN only postoperatively.
Daily patient charting with Clavien Dindo Classification, length of stay and mortality were mentioned and verified by the operating surgical team.
Data was maintained electronically by the surgical team. Data was also entered in MS-EXCEL at the time of patient discharge. Since data was maintained on everyday basis till patient discharge and does not include follow-ups, there are no missing data.
Upon completion of study, all data will be exported to SPSS and analyzed accordingly using means, SDs, Chi-square and Fisher exact test.
- Conditions
- Parenteral Nutrition, Major Surgery, Malnutrition
- Being tested
- TPN-N7 Baxter
- Keywords
- parenteral nutrition, TPN, major surgery, malnutrition in surgery, clavien-dindo classification
- Medical subject headings
- Hyperphagia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN-N7 BaxterDietary supplement
providing TPN to all malnutrition patients preoperatively as well as postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Malnutrition | All malnutrition patients to received TPN for 5 days preoperatively as applicable and continued postoperatively. Receives: Dietary Supplement: TPN-N7 Baxter |
What is being measured
The primary outcome is the main question the study is designed to answer.
studying the effects of TPN on length of hospital stay
comparison of perioperative and postoperative TPN in terms of mean length of stay in days
Measured: through study completion, an average of 5years
studying the effects of TPN on mortality
comparison of perioperative and postoperative TPN in terms of number of mortality cases
Measured: through study completion, an average of 5years
studying the effects of TPN on complications using grades
comparison of perioperative and postoperative TPN in terms of Clavien-Dindo classification grades
Measured: through study completion, an average of 5years
studying the effect of albumin levels on length of hospital stay
comparison of low and normal albumin levels in terms of mean length of stay in days
Measured: through study completion, an average of 5years
studying the effect of albumin levels on mortality
comparison of low and normal albumin levels in terms of number of mortality cases
Measured: through study completion, an average of 5years
studying the effect of albumin levels on complication using grades
comparison of low and normal albumin levels in terms of Clavien-Dindo Classification grades
Measured: through study completion, an average of 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Oct 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parenteral NutritionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepal Medical College and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabin Pokharel, Nepal Medical College and Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573632
- Sponsor's protocol ID
- 26-079/080
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen GL, Mirtallo J, Compher C, Dhaliwal R, Forbes A, Grijalba RF, Hardy G, Kondrup J, Labadarios D, Nyulasi I, Castillo Pineda JC, Waitzberg D; International Consensus Guideline Committee. Adult starvation and disease-related malnutrition: a proposal for etiology-based diagnosis in the clinical practice setting from the International Consensus Guideline Committee. JPEN J Parenter Enteral Nutr. 2010 Mar-Apr;34(2):156-9. doi: 10.1177/0148607110361910.
PubMed 20375423Thomas MN, Kufeldt J, Kisser U, Hornung HM, Hoffmann J, Andraschko M, Werner J, Rittler P. Effects of malnutrition on complication rates, length of hospital stay, and revenue in elective surgical patients in the G-DRG-system. Nutrition. 2016 Feb;32(2):249-54. doi: 10.1016/j.nut.2015.08.021. Epub 2015 Sep 25.
PubMed 26688128Lakananurak N, Gramlich L. The Role of Preoperative Parenteral Nutrition. Nutrients. 2020 May 6;12(5):1320. doi: 10.3390/nu12051320.
PubMed 32384662Zhao XF, Wu N, Zhao GQ, Liu JF, Dai YF. Enteral nutrition versus parenteral nutrition after major abdominal surgery in patients with gastrointestinal cancer: a systematic review and meta-analysis. J Investig Med. 2016 Jun;64(5):1061-74. doi: 10.1136/jim-2016-000083. Epub 2016 Apr 25.
PubMed 27112357
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perioperative Parenteral Nutrition Affect Outcome in Patients Undergoing Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06573632
- Acronym / sponsor ID
- 26-079/080
- Conditions
- Parenteral Nutrition, Major Surgery, Malnutrition
- Keywords
- parenteral nutrition, TPN, major surgery, malnutrition in surgery, clavien-dindo classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nepal Medical College and Teaching HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 27 Aug 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.
Preoperative optimization of patients is a well known concept. Not all patients can tolerate feeds and as such TPN is given. TPN given preoperatively and continued postoperatively in selected group of patients can significantly improve the surgical outcomes and lower the morbidity as well as mortality. So the investigators aim to find the impact of TPN in malnutritional surgical patients.
Detailed description
Any patient who is at risk of malnutrition as well as already malnutritioned were given preoperative TPN for 5 days. After 5 days, elective surgery was done and TPN was continued postoperatively until patient could consume 50% of their daily requirements orally. Patients who underwent emergency surgeries were also enrolled in this study as these patients could receive TPN only postoperatively.
Daily patient charting with Clavien Dindo Classification, length of stay and mortality were mentioned and verified by the operating surgical team.
Data was maintained electronically by the surgical team. Data was also entered in MS-EXCEL at the time of patient discharge. Since data was maintained on everyday basis till patient discharge and does not include follow-ups, there are no missing data.
Upon completion of study, all data will be exported to SPSS and analyzed accordingly using means, SDs, Chi-square and Fisher exact test.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malnutrition | – | Dietary Supplement: TPN-N7 BaxterAll malnutrition patients to received TPN for 5 days preoperatively as applicable and continued postoperatively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting to the Surgery department at Nepal Medical College teaching hospital and having malnutrition.
Key inclusion criteria (1 listed)
- 1. All patients who underwent major gastrointestinal surgery and received perioperative TPN or postoperative TPN
Key exclusion criteria (2 listed)
- Perioperative TPN administration that did not follow the study protocol
- TPN given for reasons other than malnutrition
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 |
|---|---|---|
| TPN-N7 Baxterproviding TPN to all malnutrition patients preoperatively as well as postoperatively. | Dietary supplement | Malnutrition |
Primary outcome
studying the effects of TPN on length of hospital stay
Time frame: through study completion, an average of 5years
comparison of perioperative and postoperative TPN in terms of mean length of stay in days
studying the effects of TPN on mortality
Time frame: through study completion, an average of 5years
comparison of perioperative and postoperative TPN in terms of number of mortality cases
studying the effects of TPN on complications using grades
Time frame: through study completion, an average of 5years
comparison of perioperative and postoperative TPN in terms of Clavien-Dindo classification grades
studying the effect of albumin levels on length of hospital stay
Time frame: through study completion, an average of 5years
comparison of low and normal albumin levels in terms of mean length of stay in days
studying the effect of albumin levels on mortality
Time frame: through study completion, an average of 5years
comparison of low and normal albumin levels in terms of number of mortality cases
studying the effect of albumin levels on complication using grades
Time frame: through study completion, an average of 5years
comparison of low and normal albumin levels in terms of Clavien-Dindo Classification grades
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 27 Aug 2024.
- Background: PubMed 20375423Jensen GL, Mirtallo J, Compher C, Dhaliwal R, Forbes A, Grijalba RF, Hardy G, Kondrup J, Labadarios D, Nyulasi I, Castillo Pineda JC, Waitzberg D; International Consensus Guideline Committee. Adult starvation and disease-related malnutrition: a proposal for etiology-based diagnosis in the clinical practice setting from the International Consensus Guideline Committee. JPEN J Parenter Enteral Nutr. 2010 Mar-Apr;34(2):156-9. doi: 10.1177/0148607110361910.
- Background: PubMed 26688128Thomas MN, Kufeldt J, Kisser U, Hornung HM, Hoffmann J, Andraschko M, Werner J, Rittler P. Effects of malnutrition on complication rates, length of hospital stay, and revenue in elective surgical patients in the G-DRG-system. Nutrition. 2016 Feb;32(2):249-54. doi: 10.1016/j.nut.2015.08.021. Epub 2015 Sep 25.
- Background: PubMed 32384662Lakananurak N, Gramlich L. The Role of Preoperative Parenteral Nutrition. Nutrients. 2020 May 6;12(5):1320. doi: 10.3390/nu12051320.
- Background: PubMed 27112357Zhao XF, Wu N, Zhao GQ, Liu JF, Dai YF. Enteral nutrition versus parenteral nutrition after major abdominal surgery in patients with gastrointestinal cancer: a systematic review and meta-analysis. J Investig Med. 2016 Jun;64(5):1061-74. doi: 10.1136/jim-2016-000083. Epub 2016 Apr 25.
- Individual participant dataSharing planned: No
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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?
An observational study of Parenteral Nutrition and Major Surgery, run by Nepal Medical College and Teaching Hospital at 1 site in Nepal.
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 1 inclusion and 2 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 27 Aug 2024. 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 Nepal. 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?
studying the effects of TPN on length of hospital stay (time frame: through study completion, an average of 5years). The study lists 6 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 NCT06573632, which also lists 4 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 27 Aug 2024.