PEMAGS: Minimal access gynaecological surgery
Research type
Research Study
Full title
PEMAGS: A Prospective fEasibility study of Minimal Access Gynaecological Surgery
IRAS ID
221191
Contact name
Matthew Wood
Contact email
Sponsor organisation
University Hospitals of Leicester
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Summary of Research
Traditionally a hysterectomy has been preformed through open surgery (laparotomy). Increasingly surgery can now be performed through small cuts, commonly referred to as ‘keyhole surgery’ (minimally invasive surgery). This type of surgery can be done in two ways. Either the surgeon can hold the surgical instruments directly (laparoscopy) or robotic arms can hold the instruments and the surgeon controls them with a computer (robotic assisted laparoscopy).Both of these techniques have been used for a long time and have been shown to be safe. They are both safer than open surgery, requiring less time in hospital and shorter recovery periods. What we do not know is whether either of the keyhole surgery options produces better outcomes than the other and if so which women would benefit from one technique or the other.
This study aims to collect information before, during and after surgery by the two different keyhole surgery techniques in women who are scheduled to have either standard laparoscopic or robotic surgery. The results of this study will be used to plan a large randomised trial comparing the two different techniques.The primary outcome measure will be patient recruitment and retention, with qualitative assessment of participant comments regarding methodology. Secondary outcomes will be comparison of robotic and laparoscopic surgery regarding clinical, cost and surgeon outcomes.
Summary of Results
Lay summary of study results: This study has given an in-depth picture of the intra- and post-operative events and recovery following robotic surgery for the primary management of endometrial cancer/pre-cancer. It is known that the risks of surgery are closely associated with patient BMI due to increasing prevalence of medical co-morbidities but also due to the technical challenges of abdominal wall depth and intra-abdominal adiposity.
We have shown that even in a very high-risk population (21% of patients had BMI >50) that robotic surgery is safe, with very low rates of post-operative complications. We have also demonstrated that the recovery following surgery is good, with very low levels of analgesia required and a short time for return to normal activity. Importantly, we have shown that operating time, length of hospital stay and return to everyday activity is independent of BMI supporting the role of robotic surgery in the management of this patient population.REC name
London - South East Research Ethics Committee
REC reference
17/LO/0915
Date of REC Opinion
5 Jun 2017
REC opinion
Favourable Opinion