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Randomised controlled trial of laparoscopic primary crural repair versus additional circular bioabsorbable mesh reinforcement in hiatal hernia (PRIME-II trial): an RCT protocol

Por: de Haas · J. W. A. · Geerts · J. H. · de Boer · E. · Brohet · R. M. · Hazebroek · E. J. · Wassenaar · E. B. · Nieuwenhuijs · V. B.
Introduction

Laparoscopic hiatal hernia (HH) repair is associated with a high recurrence rate. Repair reinforced with mesh lowers short-term recurrence but can cause dysphagia and visceral erosion. Results of the PRIME trial, in which non-absorbable mesh reinforcement of the posterior crural repair was investigated, showed equal recurrence compared with primary suture repair after 6 months. This study investigates the use of circular absorbable mesh reinforcement in primary HH repair.

Methods and analysis

Prospective double-blinded randomised controlled superiority trial comparing two laparoscopic procedures for HH repair (110 vs 110). Adult patients with proven HH Skinner types II–IV (defined by preoperative CT scan) are included. Patients are randomised to undergo a laparoscopic primary crural repair with sutures alone or suture repair augmented with biosynthetic absorbable, circular mesh at the hiatus. Radiologic integrity of the hiatal repair 1 year after surgery is the main endpoint. Secondary objectives are clinical recurrence of the hernia, development of postoperative reflux disease, postoperative side effects and satisfaction with surgical outcome. Outcome assessors are blinded to allocation. Data are collected at baseline, and follow-up includes interviews and digital questionnaires at 3, 12, 24, 36, 48 and 60 months, as well as CT scan at 12 and 60 months. All patients randomised will be analysed according to the intention-to-treat principle.

Ethics and dissemination

Ethics approval has been obtained by the local ethics committee at Isala, Zwolle, the Netherlands (Medical Ethics Review Committee (METc) Isala, study number: 190516). METc Isala is no longer active; all duties have been taken over by METc of the University Medical Center Groningen. The trial’s results will be submitted to a peer-reviewed international journal as well as (inter)national conferences.

Trial registration number

Registered in the Dutch national trial registry: OMON (NL-OMON48062).

NEOadjuvant Dendritic cell therapy added to first line standard of care in advanced epithelial Ovarian Cancer (NEODOC): protocol of a first-in-human, exploratory, single-centre phase I/II trial in the Netherlands

Por: Koeneman · B. · Schreibelt · G. · Duiveman - de Boer · T. · Bos · K. · van Oorschot · T. · Pots · J. · Scharenborg · N. · de Boer · A. · Hins - de Bree · S. · de Haas · N. · de Goede · A. · Westdorp · H. · van Ham · M. · de Vries · I. J. M. · Ottevanger · P. B.
Introduction

The currently available immunotherapies have failed to meet expectations in inducing durable responses in patients with advanced epithelial ovarian cancer (EOC). The low number of somatic missense mutations in EOC necessitates highly potent neoantigen-directed approaches. To this end, we have developed a novel dendritic cell (DC) product that consists of a specialised cross-presenting subset of DC, conventional DC type 1 (cDC1).

Methods and analysis

We will conduct the NEODOC study, an investigator-initiated first-in-human phase I/II trial. This study will assess the immunogenicity, safety and feasibility of a cDC1-based, autologous tumour lysate-loaded, DC product. 10 patients with previously untreated advanced EOC (stage IIIb-c, IVa or stage IVb if only supradiaphragmatic or inguinal lymph nodes

Ethics and dissemination

Ethical approval for this trial was granted by the Netherlands Central Committee on Research Involving Human Subjects. The results will be disseminated through publications in international, open-access scientific journals and presentations at scientific conferences.

Trial registration number

NCT05773859; EUCT number 2024-512353-24-01.

Adherence to guidelines on quality neonatal resuscitation practices among healthcare professionals in Ghana: an observational study

Por: Salia · S. M. · Kaba · R. A. · de Haas · B. · Stekelenburg · J.
Aims and objectives

The study evaluated healthcare professionals’ adherence to guidelines on quality neonatal resuscitation practices in Ghana.

Design

This study employed an observational design. A validated observational checklist for neonatal resuscitation was used to assess the adherence to quality neonatal resuscitation guidelines among healthcare professionals.

Setting

The study was conducted among healthcare professionals in six healthcare facilities, consisting of five government-owned healthcare facilities and a private non-profit health facility across the northern, middle and coastal belts of Ghana.

Participants

The study participants were 75 healthcare professionals across the six sampled healthcare facilities.

Outcome measures

Outcome measures of interest are: initial preparation prior to resuscitation; stimulation and airway maintenance; positive pressure ventilation; coordinated positive pressure ventilation with chest compression and postresuscitation infection prevention and control measures.

Results

The results revealed that 53% of the healthcare professionals demonstrated good (scored 80%–100%) adherence to guidelines on quality neonatal resuscitation practices; the remaining scored moderate 36% (scored 50%–79%) and 11% (scored 0%–49%) poor adherence. Binary logistic regression analysis revealed that increased staffing levels and a bachelor’s degree or higher were positively associated with the performance of positive pressure ventilation (adjusted OR (aOR) 19.3 (95% CI 2.430799, 152.8657), p=0.005) and (aOR 9.9 (95% CI 1.070278, 92.38303), p=0.043), respectively. Furthermore, professional nurses and medical practitioners were more likely to adhere to coordinated positive pressure ventilation with chest compressions than auxiliary nursing staff (aOR 13.2 (95% CI 1.917858, 92.61999), p=0.009) and (aOR 15.7 (95% CI 1.227859, 200.1105), p=0.034).

Conclusion

The results showed that 53% of healthcare professionals demonstrated good adherence for neonatal resuscitation practices. Addressing the identified gaps and inequalities in neonatal resuscitation practice will improve healthcare professionals’ knowledge and skills in neonatal resuscitation, which ultimately helps to reduce neonatal deaths among babies in Ghana.

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