Effectiveness of Intensive Perioperative Nutrition Therapy Among Adults Undergoing Gastrointestinal & Oncology Surgery

NCT04347772 | Unknown DMC

• 1 other identifier: 43546
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Perioperative Complication

Keywords

Perioperative Nutrition Therapy; Surgical Patients; Post-operative complication

Outcome Measures

Primary Outcomes (3)

• Length of Bowel function

  To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of bowel function. The duration of bowel start function post-operatively in hours or days will be recorded. The duration covers from zero hours after surgery until the first day of bowel function presented. The start of bowel function is the first day of commencement of any type of fluids or solid food given

  2 months

• Length of solid food toleration

  To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of solid food toleration. The duration of solid food toleration post-operatively in hours or days will be recorded. The duration covers from zero hours after surgery until the first day of reintroduction of solid food.

  2 months

• Length of hospital stay

  To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of hospital stay. The duration of hospital stay in days will be recorded. The duration covers from the day of ward admission (before operation) until discharge (after operation).

  2 months

Secondary Outcomes (10)

• Malnutrition Status - The scored Patient Generated Subjective Global Assessment (PG-SGA)

  2 months

• Functional status - handgrip strength

  2 months

• Nutritional status - Body Mass Index (BMI)

  2 months

• Nutritional status - Mid Arm Circumference (MAC)

  2 months

• Nutritional status - Tricep Skinfold (TSF)

  2 months

Study Arms (2)

Supplements Group - SS

EXPERIMENTAL

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).

Dietary Supplement: Oral Nutrition Support

Control Group - NN

NO INTERVENTION

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).

Interventions

Oral Nutrition Support DIETARY_SUPPLEMENT

Intensive Nutrition Intervention

Supplements Group - SS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Hospital Serdang

Kajang, Selangor, 43000, Malaysia

RECRUITING

Related Publications (6)

• Weimann 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 RESULT

• Smedley 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 RESULT

• MacFie 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 RESULT

• Kabata 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 RESULT

• Jie 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 RESULT

• A'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 DERIVED

MeSH Terms

Interventions

Nutrition Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zalina Abu Zaid, PhD

  University Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zalina Abu Zaid, PhD

CONTACT

+0389062961; zalina@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a pragmatic randomized clinical trial involving patients undergoing major elective surgery. Baseline will be commenced before operation, when the decision to operate electively was made in the outpatient setting, and ended 6 hours before surgery. Next visit will be commenced on the first day that the patient was able to take free fluids or a light diet after operation, and ended 4 weeks after discharge from hospital.

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: April 15, 2020
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)