Clinical trial · Interventional
Effectiveness of Intensive Perioperative Nutrition Therapy Among Adults Undergoing Gastrointestinal & Oncology Surgery
Intensive Perioperative Nutrition Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Perioperative malnutrition is common in patients undergoing gastrointestinal and oncological surgery and it also associated with longer hospital stays, reduced responses to and increased complications from therapies, increased costs, poorer quality of life and lower survival rate. Evidence has shown that appropriate perioperative nutrition therapy have a significantly improve perioperative outcomes. Current practice emphasises the roles of early nutrition therapy as early intervention in order to combat the post-operative complications of patients and the implementation is now widely adopted. However, there is very limited data to date on the effects of perioperative nutrition therapy in patients before hospital admission, during hospital stay and after discharge to prevent the post-operative complications. Therefore, there is a need to study in this area in order to determine the effects of perioperative nutrition therapy to overcome the post-operative complications in patients undergoing surgery. This is a pragmatic randomized clinical trial will be conducted among sixty eight adults patient undergoing major elective surgery in Hospital Serdang. Participants will be randomized to one of two groups by means of sealed envelope into Intervention Group (SS) or Control Group (NN). All data will be collected during a face to face interview, blood sampling and direct anthropometric measurement with the participants at Hospital Serdang. The effects of intervention between treatment groups on outcome parameters will be carried out by using the SPSS General Linear Model (GLM) for repeated measure procedure. The perioperative nutrition therapy intervention implemented in the study will serve as a baseline data for providing an appropriate nutritional management in patients undergoing surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Perioperative Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Nutrition Support | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supplements Group - SS
- description
- The SS will be received tailored and more intensive and ongoing nutrition support and lifestyle advice as compared with the NN and will be supplemented with ONS, available in 400g/can, providing 226 kcal/serving and 9.6 g protein/serving. Participants will be encouraged to consume the ONS in small, frequent, in between meals. All participants will receive standard post-operative care from clinical and nurse staff with commencement of free fluids and reintroduction of normal diet without interference by the researcher or protocol. The postoperative course will be carefully monitored. While complications will be noted as major or minor by using validated criteria (Buzby et al., 1988).
- interventionNames
- Dietary Supplement: Oral Nutrition Support
- type
- NO_INTERVENTION
- label
- Control Group - NN
- description
- While participants in NN which referred as control group will received the standard care of the clinic without supplemented with ONS. Nutritional advice will be based on a guideline specifically focused on treatment of symptoms such as nausea, vomiting, loss of appetite and diarrhoea, and how to deal with the symptoms through nutritional approaches. Basically, the advice will be given by the oncologist or nurses in the clinic. All participants will receive standard post-operative care from clinical and nurse staff with commencement of free fluids and reintroduction of normal diet without interference by the researcher or protocol. The postoperative course will be carefully monitored. While complications will be noted as major or minor by using validated criteria (Buzby et al., 1988).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Those who receiving elective major surgery treatments * Aged from 18 years old to 80 years old * Malaysian * Able to communicate verbally * MST score ≥ 2 * Provided and signed informed consent Exclusion Criteria: * Those who had received pre-operative enteral or PN * Those who requiring emergency surgery * Complicated with chronic diseases and fluid retention (renal/ cardiovascular/ pulmonary/ hepatic) * Those who participated in other research study.
References
Publications (6)
- RESULTWeimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7. PMID 28385477
- RESULTSmedley F, Bowling T, James M, Stokes E, Goodger C, O'Connor O, Oldale C, Jones P, Silk D. Randomized clinical trial of the effects of preoperative and postoperative oral nutritional supplements on clinical course and cost of care. Br J Surg. 2004 Aug;91(8):983-90. doi: 10.1002/bjs.4578. PMID 15286958
- RESULTMacFie J, Woodcock NP, Palmer MD, Walker A, Townsend S, Mitchell CJ. Oral dietary supplements in pre- and postoperative surgical patients: a prospective and randomized clinical trial. Nutrition. 2000 Sep;16(9):723-8. doi: 10.1016/s0899-9007(00)00377-4. PMID 10978851
- RESULTKabata P, Jastrzebski T, Kakol M, Krol K, Bobowicz M, Kosowska A, Jaskiewicz J. Preoperative nutritional support in cancer patients with no clinical signs of malnutrition--prospective randomized controlled trial. Support Care Cancer. 2015 Feb;23(2):365-70. doi: 10.1007/s00520-014-2363-4. Epub 2014 Aug 6. PMID 25091056
- RESULTJie B, Jiang ZM, Nolan MT, Zhu SN, Yu K, Kondrup J. Impact of preoperative nutritional support on clinical outcome in abdominal surgical patients at nutritional risk. Nutrition. 2012 Oct;28(10):1022-7. doi: 10.1016/j.nut.2012.01.017. Epub 2012 Jun 5. PMID 22673593
- DERIVEDA'zim AZA, Zaid ZA, Yusof BNM, Jabar MF, Shahar ASM. Effectiveness of intensive perioperative nutrition therapy among adults undergoing gastrointestinal and oncological surgery in a public hospital: study protocol for a pragmatic randomized control trial. Trials. 2022 Nov 26;23(1):961. doi: 10.1186/s13063-022-06898-2. PMID 36435838