Dataset Information

Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Enhanced recovery after surgery (ERAS) guidelines strongly recommends that patients be in early postoperative ambulation within 24 hours. This study aims to assess the effectiveness and safety of the self-fatigue assessment method to guide patients' early postoperative ambulation.

Methods and analysis

This is a single-centre, randomised, open, parallel-controlled trial. Five hundred and fifty-two patients who meet the inclusion criteria for gynaecological oncology surgery are randomly assigned in a 1:1 ratio to either a self-fatigue assessment group (study group) or a fixed activity distance assessment group (control group). The fixed activity distance group adopts a fixed early postoperative ambulation distance to guide the patient's activity, while the self-fatigue assessment group uses the Borg Exercise Scale to assess the patient's fatigue and stops activity when the fatigue level reaches 5-6. The primary outcome measure is the time to first postoperative flatus. Secondary outcome measures are the time to first bowel movement, the incidence of moderate to severe bloating, the incidence of bowel obstruction or venous thromboembolism, the incidence of adverse events (nausea, vomiting, dizziness), patient satisfaction, sleep quality scores, patient compliance with activities, hospital costs and days in hospital.

Ethics and dissemination

This study was approved by the Independent Ethics Committee of Xiangyang Central Hospital affiliated with Hubei University of Arts and Sciences and registered with the China Clinical Trials Registry in May 2021. The results of the trial will be disseminated through open access peer-reviewed journals and abstracts will be submitted to relevant national and international conferences.

Trial registration number

CTR2100046035.

SUBMITTER: Du Q

PROVIDER: S-EPMC9161075 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial.

Du Qian Q Chen Bo B Xu Shaoyong S He Hong H Qin Xiaomin X Kang Tongting T Wang Xu X Huang Xiaojie X

BMJ open 20220601 6

<h4>Introduction</h4>Enhanced recovery after surgery (ERAS) guidelines strongly recommends that patients be in early postoperative ambulation within 24 hours. This study aims to assess the effectiveness and safety of the self-fatigue assessment method to guide patients' early postoperative ambulation.<h4>Methods and analysis</h4>This is a single-centre, randomised, open, parallel-controlled trial. Five hundred and fifty-two patients who meet the inclusion criteria for gynaecological oncology sur ...[more]

PMID: 35649597

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Project description:ObjectivesTo assess the impact of a patient-based self-assessed fatigue intervention aimed at promoting early postoperative ambulation.DesignProspective randomised controlled trial.SettingSingle-centre, conducted at the Obstetrics and Gynaecology Department of the Xiangyang Central Hospital, China.ParticipantsEligible were adult patients undergoing elective gynaecologic oncologic surgery.InterventionsThe intervention group utilised a modified Borg Rating of Perceived Experience (RPE) scale for self-assessment of fatigue levels. The control group followed fixed-activity distance guidelines postoperatively.Primary and secondary outcome measuresThe primary outcome was the self-reported the time to first flatus postoperatively. Secondary outcomes encompassed the time to first defecation, incidence of moderate-to-severe abdominal distention, ileus, postambulation adverse events (nausea, vomiting and dizziness), patient satisfaction with early ambulation instructions, compliance with early ambulation and average hospital costs and length of stay.ResultsBetween June 2021 and October 2022, 552 patients were enrolled. The self-assessed fatigue intervention group demonstrated non-inferior the time to first flatus compared with the fixed-activity distance assessment group (25.59±14.59 hours vs 26.10±14.19 hours, pnon-inferiority<0.001). Compliance with activity was higher in the intervention group (49.40% vs 36.02%, p<0.001), although it did not reach 50%. The intervention group also exhibited significantly higher mean hospital costs, length of stay and incidence of moderate-to-severe abdominal distention (p<0.001).ConclusionsThe self-assessed fatigue intervention for early postoperative ambulation in gynaecologic oncology patients shows promise as an effective strategy; however, compliance is suboptimal. An intervention based on mandatory, yet reasonable, fixed-activity distance may represent the most viable current approach. Further research is warranted to confirm these findings.Trial registration numberCTR2100046035.

Project description:OBJECTIVES:To evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients. DESIGN:Economic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up. SETTING:Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS:433 employed women aged 18-65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery. INTERVENTION:The intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227). MAIN OUTCOME MEASURES:The primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery. RESULTS:At 12 months, there were no statistically significant differences in total societal costs (€-647; 95% CI €-2116 to €753) and duration until RTW (-4.1; 95% CI -10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs. CONCLUSIONS:Considering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery. TRIAL REGISTRATION NUMBER:NTR2933; Results.

Project description:BackgroundFast-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/designThis 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.DiscussionThe 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 numberNCT02687412 . Approval Number: SCCHEC20160001. Date of registration: registered on 23 February 2016.

Dataset Information

Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial.

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