Open studies

Video Analysis in Minimally Invasive Surgery (VAMIS).

Video analysis of errors and technical performance within minimally invasive surgery.

Despite the high volumes, advanced minimally invasive surgery is non-standardised and variations often occur in surgical technique, performance, delivery, team communication, and surgical approach. Such variations can result in errors and complications that can potentially be avoided.

This project aims to analyse surgical phases (stage of the operation), skill and errors to anonymised, surgical video data through Medtronic’s Touch Surgery™ Enterprise DS1 Computer which can capture video data anonymously in any minimally invasive (key hole) procedure in the operating room, allowing immediate, upload of data to a platform for immediate feedback and assessment to surgeons. We hypothesise that understanding technical performance and surgical processes, may reduce unwarranted variations, errors and near misses, and improve the performance of the entire surgical team that is ultimately hoped to enhance patient safety and outcomes. We plan to develop assessment tools with the hope to improve feedback, learning and ultimately surgeons’ performances. We plan to apply the latest methodology manual (OCHRA) and automated assessment (artificial intelligence). We also aim to validate these methods by correlating video “scores” of skill/errors to patient outcomes e.g. complications, cancer outcome.

Full title: A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

Summary: A common problem in about 40% of patients having bowel surgery is that their bowel takes longer than normal to start working again. In most patients the bowel will start working after surgery in 3- 4 days, but in some it takes a week or more. We call this delayed recovery of gut function. This delayed recovery causes nausea, vomiting, complete
constipation, tummy pain and tummy swelling (distension). As a result, patients cannot eat or drink until gut function returns, their recovery is slower and they have to stay longer in hospital. There is no immediate cure, and although it gets better on its own in most cases, it can take from 3-7 days to do so. During this time patients have to have a continuous intravenous drip and often insertion of a nasogastric tube to empty the stomach to reduce vomiting (most patients find this very unpleasant).

One of the common drugs used in hospitals is the local anaesthetic Lidocaine, used to “freeze” parts of the body, for example for minor skin operations or dental procedures. Recently lidocaine has been used intravenously (through the vein) as part of a general anaesthetic. It reduces pain and inflammation caused by surgery, and seems to help other aspects of recovery that may be important for return of gut function, for example reducing nausea and vomiting, and shortening the time from surgery to first bowel movement. However, previous studies were small and the true benefit of Intravenous (IV) lidocaine is uncertain. We hope to find out if giving IV Lidocaine improves recovery of gut function after colorectal surgery for NHS patients

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

Full title: The ANTHEM Feasibility Study : Is A Novel THErapeutic mammaplasty procedure a safe and effective surgical alternative to Mastectomy for treatment of breast cancer?

Summary: Breast conserving surgery (BCS) is the preferred treatment for many women with breast cancer. Standard techniques, however frequently result in poor cosmetic outcomes and mastectomy (removal of the breast) with or without immediate breast reconstruction is often recommended. Currently 40% of the 55,000 women diagnosed with breast cancer each year undergo a mastectomy but of these only 1 in 4 receive reconstruction.

Oncoplastic breast conservation surgery (OPBCS) describes a range of volume replacement (e.g local perforator flap LPF)) and volume displacement techniques (e.g Therapeutic mammaplasty (TM)) that may extend the boundaries of standard BCS and allow some women to avoid mastectomy and potentially improve their quality of life.

There is a need for high-quality research to determine whether OPBCS offers a safe and effective alternative to mastectomy but preliminary work is needed to ensure a future large-scale study is feasible, well-designed and addresses questions important to patients and the NHS.

The feasibility study will have 4 parts:
1. A national survey (a nested service evaluation) to understand current national practice of OPBCS
2. A pilot study to explore how many women are suitable for OPBCS as an alternative to mastectomy; choose to undergo the procedure and whether existing patient-reported outcome questionnaires measure outcomes important to patients undergoing different types of surgery accurately and can reliably be used in a future large study.
3. Interviews with patients to explore their views of different surgical options and the adequacy of questionnaires used to assess key patient-reported outcomes
4. Design of the future study

This study will be the first-step providing high-quality evidence to support the use of OPBCS as an alternative to mastectomy. It will promote choice, improving outcomes for patients, many of whom will be long-term breast cancer survivors.

Full title: Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal surgery matched parallel cohort trial for high surgical risk cancer patients, with mid- to low rectal cancer

Summary: Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal surgery matched parallel cohort trial for high surgical risk cancer patients, with mid- to low rectal cancer

Full title: ROSSINI 2: A Phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor) multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of three in-theatre interventions, alone or in combination, to reduce SSI rates in patients undergoing abdominal surgery.

Summary: BACKGROUND: Surgical site infection (SSI) is a significant problem for patients and the health service, but is potentially preventable. Up to 25% of patients undergoing abdominal operations will develop an SSI. At an average cost of £3500 per SSI, it has been estimated that SSIs currently cost the NHS around £700 million per year, largely through prolonged postoperative inpatient stay and additional inpatient and outpatient treatment costs. Patients who develop SSIs have higher rates of pain and discomfort, with an increased risk of death following their operation.

AIM: The aim of ROSSINI 2 is to see whether three new in-theatre interventions, alone or in combination, reduce the rate of SSI.

METHODS: This multicentre, multi-arm, multi-stage, randomised clinical trial, will assess three separate in-theatre interventions used alone or in combination. The interventions include a skin preparation solution (2% alcoholic chlorhexadine skin prep) that is applied to the skin before starting surgery, a skin drape (Iodophor-impregnated incise drape) -a thin impregnated plastic sheet applied to the skin before making the incision and a sponge (gentamicin impregnated implant), which is an implant that contains antibiotics that is placed into the wound before closure. We will recruit 6613 patients from around 68 hospitals across the UK to go into the trial. The primary outcome measure is the rate of SSI at 30 days post-surgery. Numerous secondary outcomes will also be collected, including cost effectiveness of the interventions and impact on participants quality of life. Our findings will be published in international medical journals so that they can help patients globally.

For more information please contact the Clinical Research Nurse on clinical.research@ydh.nhs.uk.

Studies in follow up

UK Cohort study to Investigate the prevention of Parastomal Hernia