Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial
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.Method...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e057733.full |
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| author | Bo Chen Xu Wang Hong He Xiaojie Huang Qian Du Shaoyong Xu Xiaomin Qin Tongting Kang |
| author_facet | Bo Chen Xu Wang Hong He Xiaojie Huang Qian Du Shaoyong Xu Xiaomin Qin Tongting Kang |
| author_sort | Bo Chen |
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| description | 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. |
| format | Article |
| id | doaj-art-79a3e334d07c4832982d0e7e6ef81702 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-79a3e334d07c4832982d0e7e6ef817022025-01-27T18:00:09ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-057733Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trialBo Chen0Xu Wang1Hong He2Xiaojie Huang3Qian Du4Shaoyong Xu5Xiaomin Qin6Tongting Kang72 Department of Endocrinology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, ChinaSchool of Life Sciences, Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Nursing, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, ChinaPeking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, ChinaDepartment of Obstetrics and Gynecology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, ChinaCenter for Clinical Evidence-Based and Translational Medicine; Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, China, Xiangyang Central Hospital, Xiangyang, Hubei, ChinaDepartment of Obstetrics and Gynecology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, ChinaDepartment of Obstetrics and Gynecology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang, Hubei, ChinaIntroduction 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.https://bmjopen.bmj.com/content/12/6/e057733.full |
| spellingShingle | Bo Chen Xu Wang Hong He Xiaojie Huang Qian Du Shaoyong Xu Xiaomin Qin Tongting Kang Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial BMJ Open |
| title | Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial |
| title_full | Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial |
| title_fullStr | Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial |
| title_full_unstemmed | Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial |
| title_short | Effectiveness of the self-fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients: study protocol for a randomised controlled trial |
| title_sort | effectiveness of the self fatigue assessment in guiding early postoperative ambulation in gynaecological oncology patients study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/6/e057733.full |
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