Evidence map›Paper›PMID 38773543›Full record

ArticlePilot and feasibility studies2024

PReoperative very low-Energy diets for obese PAtients undergoing non-bariatric surgery Randomized Evaluation (PREPARE): a protocol for a pilot randomized controlled trial.

Tyler McKechnie, Karim Ramji, Maisa Saddik, Jordan Leitch, Ameer Farooq, Sunil Patel, Aristithes Doumouras, Sameer Parpia, Cagla Eskicioglu, Mohit Bhandari

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05918471 (PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05918471 naunknown statusnot on this map

PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery: A Randomized Evaluation (PREPARE Pilot)

TypeinterventionalSponsorMcMaster UniversityRan2024 to 2024Enrolled88ConditionsObesity, Non-Bariatric Surgery, Preoperative Weight Loss, Preoperative OptimizationArmsVery Low Energy Diet with Liquid Supplementation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Tyler McKechnieDepartment of Surgery, Division of General Surgery, McMaster University, 1280 Main St. W, Hamilton, ON, L8S 4L8, Canada. tyler.mckechnie@medportal.ca.ORCID http://orcid.org/0000-0002-7668-4096
Karim RamjiDepartment of Surgery, Division of General Surgery, McMaster University, 1280 Main St. W, Hamilton, ON, L8S 4L8, Canada.
Maisa SaddikDepartment of Surgery, Division of General Surgery, McMaster University, 1280 Main St. W, Hamilton, ON, L8S 4L8, Canada.
Jordan LeitchDepartment of Anesthesia and Perioperative Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, ON, Canada.
Ameer FarooqDepartment of Surgery, Division of General Surgery, Queen's University, Kingston Health Sciences Centre, Kingston, ON, Canada.
Sunil PatelDepartment of Surgery, Division of General Surgery, Queen's University, Kingston Health Sciences Centre, Kingston, ON, Canada.
Aristithes DoumourasDepartment of Surgery, Division of General Surgery, McMaster University, 1280 Main St. W, Hamilton, ON, L8S 4L8, Canada.
Sameer ParpiaDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Cagla EskiciogluDepartment of Surgery, Division of General Surgery, McMaster University, 1280 Main St. W, Hamilton, ON, L8S 4L8, Canada.
Mohit BhandariDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with obesity presenting in need of surgical intervention are at 2-to-sixfold higher risk of prolonged hospitalization, infectious morbidity, venous thromboembolism, and more. To mitigate some of these concerns, prescribed preoperative weight loss via very low-energy diets (VLEDs) has become a standard of care for patients with obesity undergoing bariatric surgery. While VLEDs have become standard prior to bariatric surgery, their application in other surgical settings remains limited. A large, definitive trial is required to resolve the uncertainty surrounding their use in these patients. Prior to a definitive trial to compare the efficacy of VLEDs in patients with obesity undergoing major non-bariatric surgery, we require a pilot trial. We argue a pilot trial will provide the following critical feasibility insights: (1) assessment of recruitment ability, (2) evaluation of adherence to VLED regimens, and (3) assessment of our ability follow patients completely.

methodsThe proposed trial will be a multi-center, surgeon, outcome assessor, and data-analyst blinded, parallel pilot randomized controlled trial (RCT). Patients older than 18 years of age with a body mass index (BMI) of greater than 30 kg/m DISCUSSION: The PREPARE pilot RCT will aim to provide feasibility and safety data that will allow for the successful completion of the definitive PREPARE trial that has the potential to provide practice changing data pertaining to the regular use of VLEDs as a means of pre-habilitation for patients with obesity undergoing major non-bariatric surgery.

trial registrationThis study was registered on ClinicalTrials.gov (reference #NCT05918471) on June 23, 2023.

Indexed as

ObesityPrehabilitationPreoperative optimizationSurgical proceduresWeight lossWeight loss products

Identifiers

PMID38773543
PMCPMC11106982

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.