Perioperative Complication Clinical Trial
Official title:
Intensive Perioperative Nutrition Therapy
NCT number | NCT04347772 |
Other study ID # | 43546 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | December 31, 2021 |
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.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Serdang | Kajang | Selangor |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia |
Malaysia,
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. — View Citation
Kabata P, Jastrzebski T, Kakol M, Król 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 — View Citation
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. — View Citation
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( — View Citation
Weimann A, Braga M, Carli F, Higashiguchi T, Hübner 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Malnutrition Status - The scored Patient Generated Subjective Global Assessment (PG-SGA) | To examine malnutrition status in gastrointestinal and oncologic surgical patients in intervention group versus control group via Scored PG-SGA©. It consisted of two sections with seven domains. The first section, completed by the participant, is comprise of weight, food intake, symptoms, activities, as well as function. The second section will be completed by the researcher as it covered the disease and its relation to nutritional requirements, determination of metabolic demands, and followed by a nutrition-related physical examination. PG-SGA© scores that ranged from 0-35 reflected a greater risk of malnutrition. These scores will be transformed into global ratings - Stage A, B and C-which represented the states of being well-nourished, moderately malnourished, and severely malnourished, respectively. Data will be collected during baseline and at the end of visit. | 2 months | |
Secondary | Functional status - handgrip strength | To examine functional status in gastrointestinal and oncologic surgical patients in intervention group versus control group. Handgrip strength will be measured on the non-dominant hand using Jamar hand dynamometer. Subjects will be sat with their shoulder adducted and neutrally rotated, elbow flexed at 90º, forearm in neutral position, and standard verbal instructions will be given to the subjects to squeeze the dynamometer as hard as possible for three times after an interval of 5 seconds in between grips. Average of three successive attempts will be used as the final result. | 2 months | |
Secondary | Nutritional status - Body Mass Index (BMI) | To examine nutritional status in gastrointestinal and oncologic surgical patients in intervention group versus control group through BMI. Body weight and height will be taken with participants being shoeless and wearing lightweight clothing with empty pockets, without watches, or other accessories. Weight will be determined to the nearest 0.1 kg using a digital weighing scale. The machine will be calibrated every morning with a standard weight before it will be used. Height will be measured in the standing position to the nearest 0.1 cm using a SECA 206 microtoise tape which will be attached to the wall. All measurements will be taken twice by the same investigators, and the average will be used. Weight and height of the participants will be then used to calculate BMI. Data will be collected at baseline, first and at the end of visit. | 2 months | |
Secondary | Nutritional status - Mid Arm Circumference (MAC) | To examine nutritional status in gastrointestinal and oncologic surgical patients in intervention group versus control group through Mid Arm Circumference (MAC). MAC will be taken without any sleeve at measured arm, watches or other accessories. Subject is in a relaxed standing position with the arms hanging by the sides. MAC will be measured in the middle arm (same distant) from acromiole and radiale bone, to the nearest 0.1 cm using SECA 201 circumference measuring tape (SECA, British Indicators Ltd., United Kingdom). The caliper will be calibrated every morning before it will be used to minimize error during measurement. All anthropometric measurements will be taken twice by the same investigators, and the average will be used. Data will be collected at baseline, 1st and at the end of visit. | 2 months | |
Secondary | Nutritional status - Tricep Skinfold (TSF) | TSF will be taken without any sleeve at measured arm, watches or other accessories. Subject is in a relaxed standing position with the arms hanging by the sides. MAC will be measured first to determine the location of TSF measurement. TSF will be measured at the most posterior part of the triceps when viewed from the side at MAC level, to the nearest 0.1 mm using Harpenden skinfold caliper. The caliper will be calibrated every morning before it will be used to minimize error during measurement.All anthropometric measurements will be taken twice by the same investigators, and the average will be used. Data will be collected at baseline, 1st and at the end of visit. | 2 months | |
Secondary | Nutritional status - Serum Albumin | To examine nutritional status in gastrointestinal and oncologic surgical patients in intervention group versus control group by serum albumin. Data on serum albumin level will be obtained from patients' medical report at baseline and at the end of visit. | 2 months | |
Secondary | Nutritional status - Serum white blood cell | To examine nutritional status in gastrointestinal and oncologic surgical patients in intervention group versus control group by serum white blood cell (WBC). Data on WBC level will be obtained from patients' medical report at baseline and at the end of visit. | 2 months | |
Secondary | Nutritional status - Serum Haemoglobin | To examine nutritional status in gastrointestinal and oncologic surgical patients in intervention group versus control group by serum haemoglobin (Hb). Data on Hb level will be obtained from patients' medical report at baseline and at the end of visit. | 2 months | |
Secondary | Nutritional status - Serum C-reactive protein (CRP) | To examine nutritional status in gastrointestinal and oncologic surgical patients in intervention group versus control group by serum C-reactive protein (CRP). 10 ml of venous blood will be taken following overnight fast. The samples will be separated immediately by means of centrifugation (1800g for 10 min at 4°C). The serum will be stored at -80°C until analysis for the measurement of C-reactive protein which will be performed after all samples are collected. Serum C-reactive protein will be measured using the latex photometric immunoassay. Blood sample for CRP will be taken at baseline and at the end of visit. | 2 months | |
Secondary | Nutritional status - Dietary Intake | To examine nutritional status in gastrointestinal and oncologic surgical patients in intervention group versus control group by dietary intake. Dietary intake will be measured through a 24-hour dietary recall at baseline and two days of 24-hour dietary records during visit 1 & 3. Details of food information and descriptions, which included brand names, preparation and cooking methods, as well as recipes of any mixed dishes eaten during the study period, will be also recorded. Both groups will be provided an explanation by the researcher on how to record their 2-days intake in a food diary. They will be also given a detailed set of instructions together with a food album. The food album lists commonly consumed food and includes details of portion sizes to facilitate recalls of serving size and improve accuracy. A computerized local dietary analysis program, Nutritionist Pro version 2.0 will be used to analyze the nutrient intakes of the patients. | 2 months |
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