Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial

Trials, Dec 2016

Background Fast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, but this is an assumption, as FTS in elective gynaecological surgery has not been well studied. No consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, there are no published randomised controlled trials; however, some studies have shown that FTS in gynaecological oncological surgery leads to early hospital discharge with high levels of patient satisfaction. The aim of this study is whether FTS reduces the length of stay in hospital compared to traditional management. The secondary aim is whether FTS is associated with any increase in post-surgical complications compared to traditional management (for both open and laparoscopic surgery). Methods/design This trial will prospectively compare FTS and traditional management protocols. The primary endpoint is the length of post-operative hospitalisation (days, mean ± standard deviation), defined as the number of days between the date of discharge and the date of surgery. The secondary endpoints are complications in both groups (FTS versus traditional protocol) occurring during the first 3 months post-operatively including infection (wound infection, lung infection, intraperitoneal infection), post-operative nausea and vomiting, ileus, post-operative haemorrhage, post-operative thrombosis, and the Acute Physiology and Chronic Health Enquiry II score. Discussion The advantages of FTS most likely extend to gynaecology, although, to our knowledge, there are no randomised controlled trials. The aim of this study is to compare the post-operative length of hospitalisation after major gynaecological or gynaecological oncological surgery and to analyse patients’ post-operative complications. This trial may reveal whether FTS leads to early hospital discharge with few complications after gynaecological surgery. Trial registration number NCT02687412. Approval Number: SCCHEC20160001. Date of registration: registered on 23 February 2016.

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Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial

Cui et al. Trials Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial Ling Cui 0 Yu Shi 0 GN Zhang 0 0 Department of Gynaecological Oncology, Sichuan Cancer Hospital , Chengdu 610041, Sichuan , People's Republic of China Background: Fast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, but this is an assumption, as FTS in elective gynaecological surgery has not been well studied. No consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, there are no published randomised controlled trials; however, some studies have shown that FTS in gynaecological oncological surgery leads to early hospital discharge with high levels of patient satisfaction. The aim of this study is whether FTS reduces the length of stay in hospital compared to traditional management. The secondary aim is whether FTS is associated with any increase in post-surgical complications compared to traditional management (for both open and laparoscopic surgery). Methods/design: This trial will prospectively compare FTS and traditional management protocols. The primary endpoint is the length of post-operative hospitalisation (days, mean ± standard deviation), defined as the number of days between the date of discharge and the date of surgery. The secondary endpoints are complications in both groups (FTS versus traditional protocol) occurring during the first 3 months post-operatively including infection (wound infection, lung infection, intraperitoneal infection), post-operative nausea and vomiting, ileus, post-operative haemorrhage, post-operative thrombosis, and the Acute Physiology and Chronic Health Enquiry II score. Discussion: The advantages of FTS most likely extend to gynaecology, although, to our knowledge, there are no randomised controlled trials. The aim of this study is to compare the post-operative length of hospitalisation after major gynaecological or gynaecological oncological surgery and to analyse patients' post-operative complications. This trial may reveal whether FTS leads to early hospital discharge with few complications after gynaecological surgery. Fast-track surgery; Gynaecological surgery; Oncological surgery; Post-operative length of hospitalisation; Randomised controlled study - Background Fast-track surgery (FTS), also known as enhanced recovery after surgery, was initiated in 1995 by Bardram et al. [1]. FTS is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing re-admission rates, and reduce healthcare costs, all without compromising patient safety [2]. FTS has been adopted by gynaecological, colorectal and upper GI specialities worldwide, and has been used successfully in non-malignant gynaecological surgery [3, 4], and is especially effective in elective colorectal surgery [5-7]. The speed of post-operative recovery is influenced by multiple factors including pain, post-operative nausea and vomiting (PONV), paralytic ileus, fatigue, and sleep disturbances. A multimodal approach to prevent and minimise these factors is considered essential to enhance recovery [2, 5, 6, 8]. Fast-track principles include providing the patient with thorough pre-operative information and education concerning pre-, intra- and post-operative care, the use of safe and short-acting anaesthetics, optimal dynamic pain relief with minimal use of opioids, management of PONV, enteral nutrition and early mobilisation, and the use of minimally invasive surgery [9]. The advantages of FTS documented in abdominal surgery most likely extend to gynaecological surgery; however, this is an assumption because FTS in elective gynaecological surgery has not been well studied. One study has shown that FTS in gynaecological oncology provides early hospital discharge and high levels of patient satisfaction [10]. However, no consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, no randomised controlled trials have been published [3, 11, 12]. In traditional surgical care, patients are often admitted to hospital the day before the planned surgery, undergo pre-operative mechanical and antibiotic bowel preparation, and receive ongoing intravenous fluids to maintain fluid balance prior to surgery or anaesthesia. Intraoperatively, patients are often volume-loaded to maintain filling pressures, receiv (...truncated)


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Ling Cui, Yu Shi, GN Zhang. Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial, Trials, 2016, pp. 597, 17, DOI: 10.1186/s13063-016-1688-3