Surgical Trials


Dedicated to raising the profile of clinical trials in surgery. Surgical trials offers the busy surgeon with an update of important clinical trials being developed or in progress in surgery.
Focusing on the rationale and content of new surgical trials, it gives surgeons and trainees the opportunity to learn what interventions are being evaluated and why and how they may contribute.
IMPROVE-AD: Randomized trial for uncomplicated Type B Aortic Dissection

IMPROVE-AD: Randomized trial for uncomplicated Type B Aortic Dissection

The IMPROVE-AD study is funded by the National Heart, Lung, and Blood Institute in the US. The study aims to understand how best to treat type B aortic dissection. It will include up to 1,100 patients from 60 hospitals across the United States and Canada. The trial is powered to demonstrate whether upfront thoracic endovascular repair (TEVAR) is superior to the standard of care of Medical Therapy and intervention when needed during follow up over 4 years. The entire study duration is 7 years with a planned completion in 2030.

27 October 2025
THrough knee AMputation’s impact on quality of Life compared to abovE knee ampuTation: THE HAMLET TRIAL

THrough knee AMputation’s impact on quality of Life compared to abovE knee ampuTation: THE HAMLET TRIAL

Sophie James , Sean Pymer , Catherine Arundel, Laura Doherty, Tom Davill, George Smith

In the UK, around 5,000 major lower limb amputations (MLLA) occur every year, meaning that every 2 hours, someone in the UK has a leg removed and their life is changed forever. This number is increasing due to the ageing population and rising prevalence of diabetes. The care of these patients costs the NHS approximately £200 million a year, not including costs associated with formal and informal care, homecare visits and residential or nursing home placement. Following MLLA many patients do not return to independent living, with approximately one third being discharged to a care facility. MLLA also leads to substantial health implications, including anxiety, depression, altered body image and social discomfort, and the loss of general fitness and independence, which all contribute further to patient burden and healthcare costs.
MLLA includes below knee amputations (BKA), above knee amputations (AKA) and through knee amputations (TKA). Irrespective of the level of amputation, a MLLA has a significant impact on quality of life, though this can be mitigated. A recent review found that the ability to walk successfully with a prosthetic limb following MLLA, something more difficult with an AKA, had the greatest positive impact on quality of life. Accordingly, a BKA to preserve the knee joint, and thus maximise potential to utilise a prosthesis, is performed in preference to higher levels of amputation wherever possible. Patients not suitable for a BKA are usually offered an AKA, and less commonly a TKA as an alternative. Compared to an AKA, a TKA may result in superior outcomes via improved rehabilitation, easier control of an artificial leg and/or balance in a wheelchair. However, a TKA can also result in wound healing complications. Patients report positive and negative experiences with both AKA and TKA.
When a BKA is not suitable, both AKA and TKA surgeries are used in clinical practice. TKA is rarely used in the UK (less than 2% of MLLA) though may confer benefits as above, however, high-quality research to provide evidence to clearly define which amputation method results in the best outcomes for patients is lacking.

20 October 2025
Closing the treatment gap in knee osteoarthritis — the GEKO trial begins

Closing the treatment gap in knee osteoarthritis — the GEKO trial begins

Dr Raman Uberoi, Dr Anjali Shah, Dr Bhavisha Patel, Dr Loretta Davies, Professor Andrew Price, GEKO study group

Knee osteoarthritis is one of the most common musculoskeletal conditions, affecting almost one in five people over the age of 45 in the UK — around 4 million people. For many, it means living with chronic pain, limited mobility, and a gradual decline in quality of life. At its most severe, the only effective option is knee replacement surgery.
But what about those who aren’t yet at that stage? Despite trying physiotherapy, anti-inflammatories, and combinations of painkillers, many patients remain stuck in a treatment gap. Their pain is poorly controlled, yet surgery is not an option.
A new approach — genicular artery embolisation (GAE) — might offer hope. The procedure blocks small blood vessels around the knee that are thought to drive inflammation and pain. Early studies have hinted at benefit, but the evidence so far is mixed: one small trial showed no improvement, while another found a modest reduction in pain. Despite this uncertainty, the technique is already being used internationally.

16 October 2025
THRIVE Trial: Advancing Thromboprophylaxis in Superficial Venous Intervention

THRIVE Trial: Advancing Thromboprophylaxis in Superficial Venous Intervention

Sarah Whittley

Superficial venous intervention has transformed the treatment of varicose veins, offering patients minimally invasive solutions with excellent short-term outcomes. Yet, despite technical advances, an important question remains unresolved: Should pharmacological thromboprophylaxis be routinely prescribed to prevent postoperative deep vein thrombosis (DVT)?
The THRIVE trial (THRomboprophylaxis In superficial endovenous interVEntion) is the first randomised controlled study designed to address this uncertainty.1 By generating robust clinical evidence, THRIVE has the potential to influence international practice and shape future guideline recommendations.
Varicose veins are common, affecting up to 45% of the UK population and are associated with reduced physical and mental health-related quality of life.2,3 Symptomatic varicose veins are now routinely treated with endovenous thermal ablation, non-thermal ablation or mechanochemical techniques.4 While effective, these procedures carry a recognised risk of venous thromboembolism (VTE).

3 October 2025
The NEON trial: nerve repair vs. alignment for digital nerve injuries

The NEON trial: nerve repair vs. alignment for digital nerve injuries

Justin C R Wormald, MRCS, DPhil

The NEON (Nerve rEpair Or Not) trial is a randomized controlled trial investigating whether microsurgical suture repair provides benefits over simple nerve alignment for digital nerve injuries—one of the most common nerve injuries requiring surgical treatment.1 Digital nerve injuries affect approximately 3,000 patients annually in the UK, typically caused by sharp lacerations to fingers.2 Standard treatment involves specialist referral and direct suture repair under microscope magnification. However, prior to NEON, no randomized trials had compared suture repair to non-repair approaches, with existing evidence limited to small, biased observational studies.3
This multicentre trial randomized 122 adult patients with suspected unilateral digital nerve injuries across 17 NHS hospitals. After surgical exploration confirmed nerve division, participants were randomized 1:1 to either:
Microsurgical suture repair: Nerve ends aligned and sutured under magnification

4 September 2025