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Effectiveness and safety of acupuncture and moxibustion for defecation dysfunction after sphincter-preserving surgery for rectal cancer: protocol for systematic review and meta-analysis.

ABSTRACT: INTRODUCTION:Defecation dysfunction (DD) is one of the most common complications following sphincter-preserving surgery for rectal cancer. And there is no effective treatment of DD after sphincter-preserving surgery for rectal cancer. Although some studies suggested that acupuncture and moxibustion (AM) is effective and safe for DD after sphincter-preserving surgery for rectal cancer, lacking strong evidence, for instance, the relevant systematic review, meta-analysis and randomised controlled trial (RCT) of a large, multicentre sample, makes the effects and safety remain uncertain. The present protocol is described for a systematic review and meta-analysis to investigate the effectiveness and safety of AM for DD after sphincter-preserving surgery for rectal cancer. METHODS AND ANALYSIS:We will search nine online databases from inception to 1 October 2019; the language of included trials will not be restricted. This study will include RCTs that performed AM as the main method of the experimental group for patients with DD after sphincter-preserving surgery for rectal cancer. Two of the researchers will independently select the studies, conduct risk of bias assessment and extract the data. We will use the fixed-effects model or random-effects model of RevMan V.5.2 software to analyse data synthesis. The risk ratios with 95% CIs and weighted mean differences or standardised mean differences with 95% CIs will be used to present the data synthesis outcome of dichotomous data respectively and the continuous data. Evidence quality of outcome will be assessed by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. ETHICS AND DISSEMINATION:Ethical approval is not required in this secondary research evidence, and we will publish the results of this study in a journal or concerned conferences. TRIAL REGISTRATION NUMBER:CRD42019140097.

SUBMITTER: Xu G

PROVIDER: S-EPMC7223156 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effectiveness and safety of acupuncture and moxibustion for defecation dysfunction after sphincter-preserving surgery for rectal cancer: protocol for systematic review and meta-analysis.

Xu Guixing G Xiao Qiwei Q Lei Hanzhou H Fu Yanan Y Kong Jing J Zheng Qianhua Q Zhao Ling L Liang Fanrong F

BMJ open 20200506 5

<h4>Introduction</h4>Defecation dysfunction (DD) is one of the most common complications following sphincter-preserving surgery for rectal cancer. And there is no effective treatment of DD after sphincter-preserving surgery for rectal cancer. Although some studies suggested that acupuncture and moxibustion (AM) is effective and safe for DD after sphincter-preserving surgery for rectal cancer, lacking strong evidence, for instance, the relevant systematic review, meta-analysis and randomised cont ...[more]

PMID: 32381535

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Project description:BACKGROUND:Although controversial, there are data suggesting that clinical parameters can predict the probability of sphincter preserving procedures in rectal cancer. The purpose of this study was to investigate the association between clinical parameters and the sphincter-preserving surgery rate in patients who had undergone neoadjuvant combination therapy for advanced low rectal cancer. METHODS:In this single center study, the charts of 540 patients with locally advanced rectal cancer who had been treated with induction chemotherapy-and/or neoadjuvant concomitant radiochemotherapy (nRCT) over an 11-year period were reviewed in order to identify patients with rectal cancer ?6?cm from the anal verge, who had received the prescribed nRCT only. Univariate and multivariate analyses were used to identify pretreatment patient- and tumor associated parameters correlating with sphincter preservation. Survival rates were calculated using Kaplan-Meier analyses. RESULTS:Two hundred eighty of the 540 patients met the selection criteria. Of the 280 patients included in the study, 158 (56.4%) underwent sphincter-preserving surgery. One hundred sixty-four of 280 patients (58.6%) had a downsizing of the primary tumor (ypT?<?cT) and 39 (23.8%) of these showed a complete histopathological response (ypT0 ypN0). In univariate analysis, age prior to treatment, Karnofsky performance status, clinical T-size, relative lymphocyte value, CRP value, and interval between nRCT and surgery, were significantly associated with sphincter-preserving surgery. In multivariate analysis, age (hazard ratio (HR)?=?1.05, CI95%: 1.02-1.09, p?=?0.003), relative lymphocyte value (HR?=?0.94, CI95%: 0.89-0.99, p?=?0.029), and interval between nRCT and surgery (HR?=?2.39, CI95%: 1.17-4.88, p?=?0.016) remained as independent predictive parameters. CONCLUSIONS:These clinical parameters can be considered in the prognostication of sphincter-preserving surgery in case of low rectal adenocarcinoma. More future research is required in this area.

Project description:Background:Defunctioning stoma is widely used to reduce anastomotic complications in rectal cancer surgery. However, the complications of stoma and stoma reversal surgery should not be underestimated. Furthermore, in some patients, stoma reversal failed. Here, we investigated the complications of defunctioning stoma surgery and subsequent reversal surgery and identify risk factors associated with the failure of getting stoma reversed. Methods:In total, 154 patients who simultaneously underwent low anterior resection and defunctioning stoma were reviewed. Patients were divided into two groups according to whether their stoma got reversed or not. The reasons that patients received defunctioning stoma and experienced stoma-related complications and the risk factors for failing to get stoma reversed were analysed. Results:The mean follow-up time was 47.54 (range 4.0-164.0) months. During follow-up, 19.5% of the patients suffered stoma-related long-term complications. Only 79 (51.3%) patients had their stomas reversed. The morbidity of complications after reversal surgery was 45.6%, and these mainly consisted of incision-related complications. Multivariate analyses showed that pre-treatment comorbidity (HR = 3.17, 95% CI 1.27-7.96, P = 0.014), postoperative TNM stage (HR = 2.55, 95% CI 1.05-6.18, P = 0.038), neoadjuvant therapy (HR = 2.75, 95% CI 1.07-7.05, P = 0.036), anastomosis-related complications (HR = 4.52, 95% CI 1.81-11.29, P = 0.001), and disease recurrence (HR = 24.83, 95% CI 2.90-213.06, P = 0.003) were significant independent risk factors for a defunctioning stoma to be permanent. Conclusions:Defunctioning stoma is an effective method to reduce symptomatic anastomotic leakage, but the stoma itself and its reversal procedure are associated with high morbidity of complications, and many defunctioning stomas eventually become permanent. Therefore, surgeons should carefully assess preoperatively and perform defunctioning stomas in very high risk patients. In addition, doctors should perform stoma reversal surgery more actively to prevent temporary stomas from becoming permanent.

Dataset Information

Effectiveness and safety of acupuncture and moxibustion for defecation dysfunction after sphincter-preserving surgery for rectal cancer: protocol for systematic review and meta-analysis.

Publications

Effectiveness and safety of acupuncture and moxibustion for defecation dysfunction after sphincter-preserving surgery for rectal cancer: protocol for systematic review and meta-analysis.

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