Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

Bariatric surgery stigma from the perspective of patients: A scoping review

Por: Franshelis K. Garcia · Bob C. Mulder · Eric J. Hazebroek · Maria A. Koelen · Esther J. Veen · Kirsten T. Verkooijen

Abstract

Aims

To explore the experiences and consequences of bariatric surgery stigma from the perspective of bariatric surgery patients and to identify knowledge gaps in the literature.

Design

A scoping review.

Data Sources

Studies published between December 2002 and January 2022 were identified from the following databases: PubMed, Web of Science, PsycINFO and MEDLINE.

Review Methods

We screened 3092 records and included 28 studies. Findings were grouped thematically using the health stigma discrimination framework.

Results

Patients experienced several types of stigmas, including perceived, experienced, anticipated and internalized stigma, related to undergoing bariatric surgery. Patients were confronted with negative comments and judgement from others when they disclosed their decision to have surgery or when they revealed that they had undergone surgery. These experiences led to conflicts in the decision-making process, such as delaying the choice for surgery, seeking surgery abroad or opting out. Patients who internalized stigma often reported feelings of shame and embarrassment for choosing surgery and felt the need for secrecy or selective disclosure. Stigma experiences were influenced by gender and differed between different subgroups of patients.

Conclusion

The stigma surrounding bariatric surgery has detrimental consequences for eligible individuals and bariatric surgery patients. However, the evidence from patients' perspective remains limited. More research into patient's experiences is needed to improve patient care and further educate healthcare professionals. In addition, to better understand the nature and implications of bariatric surgery stigma, future research should be founded on stigma theories and distinguish between the different types of stigmas.

Impact

This scoping review contributes to a better understanding of the implications the stigma surrounding bariatric surgery has for bariatric surgery patients before and after surgery. The knowledge generated by this review can inform improvements in the education and management of people living with obesity and bariatric surgery patients.

Reporting Method

The scoping review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews checklist.

Patient or Public Contribution

No Patient or Public Contribution.

Protocol Registration

A protocol was not registered for this scoping review.

FreshRSS