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Delivery of major complex endocrine surgery as day cases

An investigation into the feasibility of day surgery for complex major endocrine operations to identify safer, more cost effective and efficient ways to provide laparoscopic adrenalectomy cases.

Read comments 23
  • Proposal
  • 2023

Meet the team

Also:

  • Mr. Gabriele Galata, Prof. Klaus-Martin Schulte, Mr Johnathan Hubbard, Mrs Karen Harries, Mrs Helena Hanschell, Mrs Nadia Talat, Mr Patrick Klang, Mr Ammar Al-Lawati, Mr Assef Jawaada

What is the challenge your project is going to address and how does it connect to the theme of 'How can improvement be used to reduce delays accessing health and care services'?

Limited access to surgical hospital beds and operating theatres places some 7m patients on lengthy waiting lists. The COVID-19 pandemic highlighted a need for safer pathways to reduce nosocomial transmission. Bypassing main transmission sites could reduce infection rates, subsequent loss of life and hospital resources, and Covid-induced deterioration during post-operative stress.

Whilst routine procedures such as hernia repair or gallbladder removal are already established as day surgery, shifting major complex surgeries to the day case setting is met with significant challenges and implementation hurdles, which we seek to address through this grant. The key challenge is to migrate a significant partition of laparoscopic adrenalectomy (LADX) to day surgery in a manner that is safe, procedurally equivalent, cost-effective, and acceptable in terms of patient experience. A further challenge is to ensure day surgery episodes are not just equivalent but possibly superior to inpatients stays

What does your project aim to achieve?

Our retrospective matched case-control study provides level 3 evidence for day surgery adrenalectomy, which demonstrated waiting time reduction from 24 months to <2 months for eligible patients. We will perform a prospective cohort study (therapeutic) to deliver level 2 evidence of the feasibility and safety of adrenalectomy in day surgery. Based on the same cohort, we will design a co-study to deliver on endpoints cost-effectiveness and patient satisfaction. In a co-designed study, we will explore the perceptions of General Practitioners and Endocrinologists. Results will be published in QI journals.

How will the project be delivered?

In phase 1, we will develop and consult the trial design of the prospective matched case-control study with key stakeholders (anaesthetic teams, patients, day surgery nursing team, endocrinologists) and biostatisticians. We will create a dedicated tool for pre-admission risk stratification.

We will consult the trial design for cost outcomes with a suitable health economist (likely at ANU) and patient satisfaction outcomes with an experienced analyst.

We will seek HREC permission at the earliest juncture and will implement any specific advice into our trial protocols.

In phase 2a, a trial implementation document will be consulted with all stakeholders.

In phase 2b, we will deliver team training to all involved parties, and develop educational material for patients.

In phase 3, patient review and consent, followed by surgical interventions as per trial stipulations.

How is your project going to share learning?

Scientific publications, presentation to National and International Congresses and organization of courses will help us to train other colleagues to deliver same quality of care across the nation. In the framework of our professional organisation, the British Association of Thyroid and Endocrine Surgeons BAETS, we will host a webinar dedicated to dissemination of adrenal specific processes. We already host a similar event for the wider implementation of endocrine day surgery under this remit. Results of the three identified trials and investigations will be published in QI journals.

How you can contribute

  • We would appreciate advice for how best to share learning through QI communities who may wish to support their local surgical teams to use the model we are developing in their hospitals.

Plan timeline

1 Oct 2023 Develop trial design of the prospective matched case-control study
1 Dec 2023 Create a dedicated tool for pre-admission risk stratification
15 Dec 2023 Consult trial design for cost outcomes with a health economist
31 Jan 2024 Assess patient satisfaction outcomes with an experienced analyst
28 Feb 2024 Trial implementation document
31 May 2024 Deliver team training, and develop educational material for patients
1 Aug 2024 Patient review and consent, followed by surgical interventions

Comments

  1. Guest

    Paul Bras 10 Mar 2023

    There are several potential problems with this project that should be considered.

    Firstly, the project assumes that day surgery is a safe and feasible alternative to inpatient surgery for certain procedures. While this may be true for some surgeries, it may not be the case for more complex surgeries like laparoscopic adrenalectomy. It is important to carefully evaluate the risks and benefits of day surgery for this specific procedure and ensure that appropriate patient selection and risk stratification protocols are in place.

    Secondly, the project aims to reduce waiting times for surgery, but it is unclear how the capacity of the healthcare system will be increased to accommodate the additional surgeries that will be performed as day surgeries. There may be resource constraints such as limited surgical beds, operating theatres, or staffing that could hinder the success of the project.

    Thirdly, the project aims to ensure that day surgery episodes are not just equivalent but possibly superior to inpatient stays, but it is unclear how this will be measured and evaluated. Patient experience and satisfaction are subjective measures and may not accurately reflect the safety or effectiveness of the procedure.

    Finally, the project plans to publish results in QI journals, but it is unclear how the project will ensure the quality of the data collected, analysed, and reported. It is important to have robust and transparent methods for data collection and analysis to ensure that the results are reliable and reproducible.

    1. Guest

      Gabriele 11 Mar 2023

      Dear Paul, thank you for your constructive comments.

      Regardingng your first point, we selected only patients with hyperaldosteronism or non functioning nodules with a size inferior to 5 cm. This has been proven to be safe in the American literature.

      In regards to your second point, shifting selected cases from inpatients to day surgery, will reduce the number of adrenalectomies waiting for Inpatient surgeries. Also, our current day surgery waiting list is inferior to three months. That means that patients with such pathologies are not waiting any longer up to two years but go into a maximum of three moths waiting list lime.

      Regarding your third point, safety, cost effectiveness studies and objective waiting list reductions are the basic parameters considered. Patients' satisfaction would be taken to complete a 360 degrees assessment of all the people involved in the study.

      And the last point, the study will include retrospective and prospective study. This is based on scientific evidence of American centres. The results of our experience will also be published in peer reviewed scientific journals.

      I hope I have addressed your questions at your full satisfaction.

  2. Guest

    Michael Eleftheriades 9 Mar 2023

    This is an excellent proposal, with many benefits. Reducing time in hospital is good for the patients and hospitals as well as reducing the backlog. The primary concern to be addressed is that standards are maintained despite the reduced times in hospital.

    1. Guest

      Gabriele 9 Mar 2023

      Thank you Michael for your feedback. Yes, quality of care and safety are our priority and we will ensure it is maintained all across the study.

  3. Guest

    Simon Aylwin 7 Mar 2023

    Dear Gabriele,

    This is an excellent proposal. The use of day surgery for adrenalectomy has indeed made a major difference to the waiting time. The innovation driven by necessity has proven safe and effective. It will be very useful to develop this with a formal prospective series.

    It is likely that most of the cases that are performed will be for primary hyperaldosteronism. These patients are low risk for surgery but at high risk if not treated. As they are not 'cancers' they attract a relatively low priority and this is a factor in their delay.

    For the purposes of a study it might be worth specifically stating that the day case intervention is for this precise indication. It will make the study more focussed and the perioperative protocols universal in their application.

    1. Guest

      Gabriele 9 Mar 2023

      Thank you very much for your comments. This is very useful and we will reinforce the indication for day surgery cases. Thank you again for your support.

  4. Guest

    Theo Papaioannou 6 Mar 2023

    This sounds an excellent project that seems to have the potential to radically reduce waiting time for patients. In terms of research, the consultation of key stakeholders in phases 1-2 looks crucial to me and so I assume a methodology is already in place for engaging anaesthetic teams, day surgery nursing team, endocrinologists, and above all patients who consent to take part in this study. I also understand there is a strong pedagogical aspect to this project. The overall plan for sharing the new evidence/knowledge of the feasibility/safety of adrenalectomy in day surgery seems very well thought.

    1. Guest

      Gabriele 7 Mar 2023

      Thank you very much for your comments. A multi disciplinary approach is the core for the study with a Patient led decision making.

  5. Guest

    Cecilia MJ Drapeau 3 Mar 2023

    It looks like an excellent improvement project, to perform complex procedures in day surgery setting with reduction of waiting times, especially with very  long waiting lists post pandemic.

    1. Guest

      Gabriele 3 Mar 2023

      Thank you very much for your comment. We aim to reach quick turnover and shorter stay in hospital environment.

  6. This is a great proposal. Day surgery is preferred by many patients, so there are advantages for the individuals as well as the obvious benefit to the institution and broader NHS. I suggest you capture PROMs, as well as cost benefit analysis. If you can, you should capture benefits to those not suitable for day surgery - will their pathways also be shorter due to freeing up theatre space? That would also show this was not increasing inequalities for some patient groups.

    1. Guest

      Gabriele 3 Mar 2023

      Dear Laura, thank you for your comment. Yes, it will help also Inpatient waiting list freeing space and decongesting theatre space and capacity.

  7. Guest

    Georgios Dimitriadis 1 Mar 2023

    This is a very interesting idea.

    I think that stages of the project referred to as phase 1 up to phase 3 may be misinterpreted in research terminology.

    You are requesting £40K to run this. I think this may be a bit low for this project. Have clinical and research costs be considered and is the amount requested based on a well-itemised research proposal? I would suggest you approached R&I to get some support in this regard. Perhaps also on performing a power calculation.

    Consider including PPIE in the development of the research proposal as additionally to cost outcomes, the study should consider including patient reported outcomes of greatest interest. PPIE can also help with dissemination of the results etc.

    Consider adding a second centre to convert this into a multi-centre study instead as if there is funding available to run this in more than one centres, the study may be eligible for NIHR portfolio adoption which would ensure better support.

     

    1. Guest

      Gabriele 2 Mar 2023

      Dear George you have very good points in your comments. Starting from the last point of multicentric study: I have approached other national and international centres. So far, we are the only in UK doing adrenalectomies in day surgery. You might be surprised how underdeveloped is the utilisation of day surgery across the country. I am collaborating with the British association of Day Surgery to support endocrine centres to boost the brilliant resource of day surgery units. I also approached international centres for collaboration. Either they don't have the case load, the adequate infrastructure or back up from their NHS. The PPIE and NHIR suggestion is interesting and we will investigate further. Regarding the funding, we have limited access at the moment but the initial costs will be covered by the grant. We will consider clarifying/simplify the level of phase study, which mi be misinterpreted or result unclear. Thank you again for the points raised and the advises given.

  8. This looks really interesting and moving a surgical waiting time from 24 months to <2 months has so many advantages, so much better for patients.

    1. Guest

      Gabriele 1 Mar 2023

      Thank you very much. We aim to deliver a quicker service via a dedicated team in a dedicated unit of day surgery. I am glad you appreciated it. The support from the community is always appreciated as strong motivation to perform better.

  9. Guest

    Dr Oliver Long 1 Mar 2023

    This has been a great step for patients who need adrenal surgery particularly those with benign disease who wait a long time for access to theatre.  The team have been incredibly innovative with patient selection and worked through with a strong MDT approach.

    1. Guest

      Gabriele 1 Mar 2023

      Thank you very much Oliver. This is a strong team work effort which involve the entire Trust at each and every level. Colleagues, nurses and healthcare workers believed in the project and supported the entire process. Thank you to all of you.

  10. Guest

    Louise Izatt 1 Mar 2023

    And if a case is deemed suitable for day case surgery, what proprtion might you envisage become an open procedure due to unforeseen intra-operative issues?

    In RRSO for example, this is a 5% conversion rate....and then a bed must be avaialble to admit them to after

    1. Guest

      Gabriele 1 Mar 2023

      Thank you for your question. In our Inpatient casistic we have 0% conversion rate in the last 13 years for Patient with primary hypealdosteronism. In the same period we have only two conversion from laparoscopic to open adrenalectomy. These two cases included a pheochromocytoma of about 7 cm and a severe Cushing disease. Both of the latter pathologies are not candidate for day surgery cases. We have anyway full capability of conversion in day surgery with Inpatient admission, in case of emergency. A dedicated team of anaesthetist, scrub nurses and ward nurses are allocated for the cases and an escalation process for rare cases is in place. We predict to maintain a conversion rate of 0% as all the day surgery cases are selected at the time of the MDT, confirmed with the patient at the consultation in clinic and verified at the pre-assessment days before performing the procedure in day surgery.

  11. Guest

    Biba Stanton 1 Mar 2023

    This sounds like a really interesting proposal.  What proportion of patients coming for laparoscopic adrenalectomy are likely to be suitable for day surgery?

    1. Guest

      Gabriele 2 Mar 2023

      Correction: hyperaldosteronism (not hyperparathyroidism)

    2. Guest

      Gabriele 1 Mar 2023

      Thank you for your question. We expect to select 1 candidate for day surgery every 3 patients selected for laparoscopic adrenalectomy for primary hyperparathyroidism.

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