NCT04347772

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

Status unknown NA Last updated 4 May 2021

What this trial tests

NA trial testing Oral Nutrition Support in Perioperative Complication in 68 participants. Status unknown.

Timeline

1 May 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Universiti Putra Malaysia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	68
Start date	1 May 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across Malaysia

Drugs / interventions tested

• Oral Nutrition Support

Conditions studied

• Perioperative Complication — all drugs for Perioperative Complication →

Sponsor

Universiti Putra Malaysia — full company profile →

Who can join

Adults 18 to 80, any sex, with Perioperative Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   A'zim AZA, Zaid ZA, Yusof BNM, Jabar MF, et al · · 2022 · cited 5× · PMID 36435838 · DOI 10.1186/s13063-022-06898-2
2. Effectiveness of Intensive Perioperative Nutrition Therapy Among Adults Undergoing Gastrointestinal And Oncological Surgery In Public Hospital: Study Protocol For A Pragmatic Randomised Control Trial.
   A’zim AZA, Zaid ZA, Yusof BNM, Jabar MF, et al · · 2021 · DOI 10.21203/rs.3.rs-795156/v1