Dataset Information

Effect of acupuncture on postoperative ileus after laparoscopic elective colorectal surgery: A prospective, randomised, controlled trial.

ABSTRACT:

Background

Postoperative ileus after colorectal surgery is a frequent problem that significantly delays recovery, increases perioperative costs, and negatively impacts on daily life, physical and psychosocial functioning, and wellbeing. We investigated the effect of acupuncture at different single acupoint combined with standard care on postoperative ileus.

Methods

In this single-centre, three-arm, prospective, randomised trial, we enrolled patients with primary colorectal cancer undergoing elective colorectal resection at Cancer Hospital Chinese Academy of Medical Science in Beijing, China. Patients were randomly assigned (1:1:1) to receive either electroacupuncture (EA) at ST36 or ST25 combined with standard care (two EA groups) once daily from post-operative days 1-4, or standard care alone (standard care group). The co-primary outcomes were time to first flatus and time to defecation assessed in the intention-to-treat population. This study is registered with Chictr.org.cn, ChiCTR1900027466.

Finding

Between Nov 15, 2019, and Sep 30, 2020, 129 patients were assessed for eligibility, 105 patients (35 patients per group) were enrolled and included in the intention-to-treat analysis. After receiving EA at ST36, the time to first flatus and defecation were shorter (between-group difference -10.98 [97.5% CI -21.41 to -0.56], p = 0·02 for flatus; -25.41 [-47.89 to -2.93], p = 0·02 for defecation). However, we did not observe a significant difference in time to first flatus and defecation between the EA at ST25 group and standard care group (between-group difference -5.54 [97.5% CI -15.78 to 4.70], p = 0·26 for flatus; -17.69 [-40.33 to 4.95], p = 0·08 for defecation). There were no serious adverse events.

Interpretation

Compared with standard care alone, standard care combined with EA at ST36, but not ST25, significantly enhances bowel function recovery in a postoperative setting to patients with colorectal cancer with laparoscopic elective colorectal resection.

Funding

The National Key R&D Program of China (No: 2019YFC1712100) and the National Science Fund for Distinguished Young Scholars (No:81825024).

SUBMITTER: Yang JW

PROVIDER: S-EPMC9156985 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of acupuncture on postoperative ileus after laparoscopic elective colorectal surgery: A prospective, randomised, controlled trial.

Yang Jing-Wen JW Shao Jia-Kai JK Wang Yu Y Liu Qian Q Liang Jian-Wei JW Yan Shi-Yan SY Zhou Si-Cheng SC Yang Na-Na NN Wang Li-Qiong LQ Shi Guang-Xia GX Pei Wei W Liu Cun-Zhi CZ

EClinicalMedicine 20220527

<h4>Background</h4>Postoperative ileus after colorectal surgery is a frequent problem that significantly delays recovery, increases perioperative costs, and negatively impacts on daily life, physical and psychosocial functioning, and wellbeing. We investigated the effect of acupuncture at different single acupoint combined with standard care on postoperative ileus.<h4>Methods</h4>In this single-centre, three-arm, prospective, randomised trial, we enrolled patients with primary colorectal cancer ...[more]

PMID: 35747183

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Project description:IntroductionPostoperative ileus (POI) is an inevitable complication of almost all abdominal surgeries, which results in prolonged hospitalisation and increased healthcare costs. Various treatment strategies have been developed for POI but with limited success. Electroacupuncture (EA) might be a potential therapy for POI. However, evidence from rigorous trials that evaluated the effectiveness of EA for POI is limited. Thus, the aim of this study was to examine whether EA can safely reduce the time to the first defecation after laparoscopic surgery in patients with POI.Methods and analysisThis multicentre randomised sham-controlled trial will be conducted in four hospitals in China. A total of 248 eligible participants with colorectal cancer who will undergo laparoscopic surgery will be randomly allocated to an EA group and a sham EA group in a 1:1 ratio. Treatment will be performed starting on postoperative day 1 and continued for four consecutive days, once per day. If the participant is discharged within 4 days after surgery, the treatment will cease on the day of discharge. The primary outcome will be the time to first defecation. The secondary outcome measures will include time to first flatus, tolerability of semiliquid and solid food, length of postoperative hospital stay, postoperative nausea and vomiting, abdominal distension, postoperative pain, postoperative analgesic, time to first ambulation, blinding assessment, credibility and expectancy and readmission rate.Ethics and disseminationEthics approval was obtained from the Ethics Committee of Beijing University of Chinese Medicine (number 2020BZHYLL0116) and the institutional review board of each hospital. The results will be disseminated through peer-reviewed publications. This study protocol (V.3.0, 6 March 2020) involves human participants and was approved by the ethics committees of Beijing University of Chinese Medicine (number 2020BZHYLL0116), Beijing Friendship Hospital Affiliated to Capital Medical University (number 2020-P2-069-01), Beijing Chao-Yang Hospital Affiliated to Capital Medical University (number 2020-3-11-2), National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (number 20/163-2359), and the Affiliated Hospital of Qingdao University (number QYFYKYLL711311920). The participants gave informed consent to participate in the study before taking part.Trial registration numberChiCTR2000038444.

Project description:IntroductionPostoperative ileus (POI) is an inevitable complication after abdominal surgery, often hindering recovery and prolonging hospital stay. Despite the increasing use of electroacupuncture (EA) as an alternative treatment for gastrointestinal dysfunction, its effectiveness for POI is still controversial. This study aims to verify the efficacy and safety of EA in alleviating POI.Methods and designThe study is a multicentre, randomised, sham-controlled trial. A total of 174 patients undergoing laparoscopic surgery for left-sided colorectal cancer will be randomly assigned to an EA group and a sham acupuncture group at a ratio of 1:1. Treatment for both groups will commence on the first day after the operation and continue once a day for four consecutive days. The primary outcome is time to first defecation. Secondary outcomes include time to first flatus, time to first tolerance to liquid and semiliquid diet, Functional Assessment of Cancer Therapy-Colorectal (FACT-C, V.4.0), postoperative nausea and vomiting, postoperative pain and abdominal distension, the Gastrointestinal Quality of Life Index, Self-Rating Depression Scale, Self-Rating Anxiety Scale, Gastrointestinal Symptom Rating Scale, length of the postoperative hospital stay, time to first postoperative ambulation, evaluation of the expected value of acupuncture, and satisfaction evaluation.Ethics and disseminationThe results will be disseminated through peer-reviewed publications. This study protocol (V.2.0, 1 October 2023) involves human participants and has been approved by the Ethics Committee of Sichuan Cancer Hospital (number KY-2023-041-01), Meishan Hospital of Traditional Chinese Medicine (number 2024LC001) and The Seventh People's Hospital of Chengdu (number KY2024-001-01). Each individual who agrees to participate in the research will provide written informed consent after the objectives and procedures of this study are explained to them.Trial registration numberChiCTR2400079645. Registered on 8 January 2024.

Project description:BackgroundPostoperative ileus (POI) is one of the main complications after colorectal cancer (CRC) surgery, and there is still a lack of effective treatment. At present, the evidence for improvement of POI by invasive acupuncture (manual acupuncture and electroacupuncture, IA) is limited. This meta-analysis of randomized controlled trials (RCTs) aims to systematically review and evaluate the effect of IA in improving POI after CRC surgery.MethodsThis meta-analysis was reported according to PRISMA statement and AMSTAR guidelines. The retrieval time was from the inception to February 2023. The RCTs were screened by searching the databases (PubMed, Ovid, Embase, Cochrane Library, China National Knowledge Infrastructure, VIP Database, Sinomed Database, and WANFANG). Two independent investigators screened and extracted the data, assessed the risk of bias, and performed statistical analysis. The statistical analysis was carried out by RevMan5.3. The PROSPERO International Prospective Register of Systematic Reviews received this research for registration (CRD42023387700).ResultsThirteen studies with 795 patients were included. In the primary outcome indicators: the IA group had shorter time to the first flauts [stand mean difference (SMD), -0.57; 95% CI, -0.73 to -0.41, p < 0.00001], shorter time to the first defecation [mean difference (MD), -4.92 h, 95% CI -8.10 to -1.74 h, p = 0.002] than the blank/sham stimulation (B/S) group. In the secondary outcome indicators: the IA group had shorter time to the first bowel motion (MD, -6.62 h, 95% CI -8.73 to -4.50 h, p < 0.00001), shorter length of hospital (SMD, -0.40, 95% CI -0.60 to -0.21, p < 0.0001) than the B/S group. In terms of the subgroup analysis: IA associated with enhanced recovery after surgery (ERAS) group had shorter time to the first flauts (MD, -6.41 h, 95% CI -9.34 to -3.49 h, p < 0.0001), shorter time to the first defacation (MD, -6.02 h, 95% CI -9.28 to -2.77 h, p = 0.0003) than ERAS group.ConclusionInvasive acupuncture (IA) after CRC surgery, acupuncture or electricacupuncture with a fixed number of times and duration at therapeutic acupoints, can promote the recovery of POI. IA combined with ERAS is better than simple ERAS in improving POI.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=387700, identifier CRD42023387700.

Project description:BackgroundPostoperative ileus is a major complication for persons undergoing abdominal surgery. Daikenchuto, a Japanese traditional medicine (Kampo), is a drug that may reduce postoperative ileus.ObjectivesTo assess the efficacy and safety of Daikenchuto for reducing prolonged postoperative ileus in persons undergoing elective abdominal surgery.Search methodsWe searched the following databases on 3 July 2017: CENTRAL, MEDLINE, Embase, ICHUSHI, WHO (World Health Organization) International Clinical Trials Registry Platform (ICTRP), EU Crinical Trials registry (EU-CTR), UMIN Clinical Trials Registry (UMIN-CTR), ClinicalTrials.gov, The Japan Society for Oriental Medicine (JSOM), American Society of Clinical Oncology (ASCO), Society of American Gastrointestinal and Endscopic Surgeons (SAGES). We set no limitations on language or date of publication.Selection criteriaWe included randomised controlled trials (RCTs) comparing Daikenchuto with any control condition in adults, 18 years of age or older, undergoing elective abdominal surgery.Data collection and analysisWe applied standard methodological procedures expected by Cochrane. Two review authors independently reviewed the articles identified by literature searches, extracted data, and assessed risk of bias of the included studies using the Cochrane software Review Manager 5.Main resultsWe included seven RCTs with a total of 1202 participants. Overall, we judged the risk of bias as low in four studies and high in three studies. We are uncertain whether Daikenchuto reduced time to first flatus (mean difference (MD) -11.32 hours, 95% confidence interval (CI) -17.45 to -5.19; two RCTs, 83 participants; very low-quality evidence), or time to first bowel movement (MD -9.44 hours, 95% CI -22.22 to 3.35; four RCTs, 500 participants; very low-quality evidence) following surgery. There was little or no difference in time to resumption of regular solid food following surgery (MD 3.64 hours, 95% CI -24.45 to 31.74; two RCTs, 258 participants; low-quality evidence). There were no adverse events in either arm of the five RCTs that reported on drug-related adverse events (risk difference (RD) 0.00, 95% CI -0.02 to 0.02, 568 participants, low-quality evidence). We are uncertain of the effect of Daikenchuto on patient satisfaction (MD 0.09, 95% CI -0.19 to 0.37; one RCT, 81 participants; very low-quality of evidence). There was little or no difference in the incidence of any re-interventions for postoperative ileus before leaving hospital (risk ratio (RR) 0.99, 95% CI 0.06 to 15.62; one RCT, 207 participants; moderate-quality evidence), or length of hospital stay (MD -0.49 days, 95% CI -1.21 to 0.22; three RCTs, 292 participants; low-quality evidence).Authors' conclusionsEvidence from current literature was unclear whether Daikenchuto reduced postoperative ileus in patients undergoing elective abdominal surgery, due to the small number of participants in the meta-analyses. Very low-quality evidence means we are uncertain whether Daikenchuto improved postoperative flatus or bowel movement. Further well-designed and adequately powered studies are needed to assess the efficacy of Daikenchuto.

Dataset Information

Effect of acupuncture on postoperative ileus after laparoscopic elective colorectal surgery: A prospective, randomised, controlled trial.

Background

Methods

Finding

Interpretation

Funding

Publications

Effect of acupuncture on postoperative ileus after laparoscopic elective colorectal surgery: A prospective, randomised, controlled trial.

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