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Perioperative Electroacupuncture Can Accelerate the Recovery of Gastrointestinal Function in Cancer Patients Undergoing Pancreatectomy or Gastrectomy: A Randomized Controlled Trial.

ABSTRACT: The effect of perioperative acupuncture on accelerating gastrointestinal function recovery has been reported in colorectal surgery and distal gastrectomy (Billroth-II). However, the evidence in pancreatectomy and other gastrectomy is still limited. A prospective, randomized controlled trial was conducted between May 2018 and August 2019. Consecutive patients undergoing pancreatectomy or gastrectomy in our hospital were randomly assigned to the electroacupuncture (EA) group and the control group. The patients in the EA group received transcutaneous EA on Bai-hui (GV20), Nei-guan (PC6), Tian-shu (ST25), and Zu-san-li (ST36) once a day in the afternoon, and the control group received sham EA. Primary outcomes were the time to first flatus and time to first defecation. In total, 461 patients were randomly assigned to the groups, and 385 were analyzed finally (EA group, n = 201; control group, n = 184). Time to first flatus (3.0 ± 0.7 vs 4.2 ± 1.0, P < 0.001) and first defecation (4.2 ± 0.9 vs 5.4 ± 1.2, P < 0.001) in the EA group were significantly shorter than those in the control group. Of patients undergoing pancreatectomy, those undergoing pancreaticoduodenectomy and intraoperative radiation therapy (IORT) surgery benefitted from EA in time to first flatus (P < 0.001) and first defecation (P < 0.001), while those undergoing distal pancreatectomy did not (P _flatus=0.157, P _defecation=0.007) completely. Of patients undergoing gastrectomy, those undergoing total gastrectomy and distal gastrectomy (Billroth-II) benefitted from EA (P < 0.001), as did those undergoing proximal gastrectomy (P=0.015). Patients undergoing distal gastrectomy (Billroth-I) benefitted from EA in time to first defecation (P=0.012) but not flatus (P=0.051). The time of parenteral nutrition, hospital stay, and time to first independent walk in the EA group were shorter than those in the control group. No severe EA complications were reported. EA was safe and effective in accelerating postoperative gastrointestinal function recovery. Patients undergoing pancreaticoduodenectomy, IORT surgery, total gastrectomy, proximal gastrectomy, or distal gastrectomy (Billroth-II) could benefit from EA. This trial is registered with NCT03291574.

SUBMITTER: Qiu G

PROVIDER: S-EPMC8026294 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundEvidence for the efficacy and safety of electroacupuncture (EA) on gastrointestinal function recovery after gynecological surgery is unclear.ObjectiveThis meta-analysis aimed to evaluate the effects of EA on recovery of postoperative gastrointestinal function for patients receiving gynecological surgery. Data sources: PubMed, Cochrane Central Register of Controlled Trials (CINAHL), Embase, China National Knowledge Infrastructure (CNKI), Weipu (CQVIP), and Wanfang databases were systematically searched from the inception dates to May 30, 2020, for relevant randomized controlled trials (RCTs). Study selection: RCTs that evaluated EA for postoperative gastrointestinal function directly related to gynecological surgery in adults aged 18 years or over. Data extraction and synthesis: paired reviewer independently extracted the data and assessed study quality. Standardized mean differences (SMD) were calculated as the effect measure from a random effects model. Main outcomes and measures: time to first flatus (TFF), time to bowel sounds recovery (TBS), and time to first defecation (TFD) were recorded as primary outcomes; postoperative nausea and vomiting (PONV), motilin (MTL), gastrin (GAS), pH value of gastric mucosa (pHi), gastric mucosal partial pressure of carbon dioxide (PgCO2), vasoactive intestinal peptide (VIP), and adverse event were reported as secondary outcomes.ResultsWe included eighteen RCTs (1117 participants). Our findings suggested that compared to the control group (CG), electroacupuncture group (EG) showed significant effects on TFF (SMD = -0.98, 95% CI: [-1.28, -0.68], P < 0.00001, I 2 = 69%), TBS (SMD = -0.98, 95% CI: [-1.84, -0.12], P=0.03, I 2 = 92%), and TFD (SMD = -1.23, 95% CI: [-1.59, -0.88], P < 0.0001, I 2 = 0%). Moreover, the incidence of PONV at postoperative 6 h (OR = 0.42, 95% CI: [0.27, 0.64], P < 0.0001, I 2 = 0%) and 24 h (OR = 0.46, 95% CI: [0.32, 0.68], P < 0.0001, I 2 = 0%) was lower in the EG than that in the CG, whereas no significant difference in ratio of PONV at postoperative 48 h (OR = 0.55, 95% CI: [0.20, 1.51], P=0.25, I 2 = 0%) was detected between the two groups. Meanwhile, there was a significant effect in favor of EA on the level of MTL at postoperative 6 h (SMD = -0.93, 95% CI: [-1.36, -0.61], P < 0.0001, I 2 = 21%), while no significant effect was observed at postoperative 24 h (SMD = -0.43, 95% CI: [-0.89, 0.02], P=0.06, I 2 = 69%) in the EG when compared to the CG. Additionally, a large significant effect on decreasing PgCO2 was found in the EG in comparison to the CG, but no significant effect in favor of EA on GAS, VIP, or pHi was observed. It was reported that there was one participant with pain at the needling sites and bruising, and three participants withdrew because they were not intolerant to EA.ConclusionsEA could be a promising strategy for the prevention and treatment of gastrointestinal dysfunction after gynecological surgery, including shortening TFF and TFD, TBS, regulating MTL, and decreasing the ratio of PONV within postoperative 24h. The effects on MTL and PONV varied with different intervention points, and EA used at 30 min prior to surgery might be recommended. However, the evidence quality ranged from low to very low, and large-scale and high-quality RCTs were warranted.

Project description:BACKGROUND:Postoperative morbidity following gastrointestinal tract major surgery ranges between 40% and 60%. Malnutrition, poor protein intake, and surgery-related impairment of the immune system and its function have been associated with postoperative infections. Supplemental perioperative nutrition may improve nutrition by increasing protein intake to influence cell-mediated immunity, thereby reducing the rate of postoperative infectious complications. OBJECTIVE:The primary objective of our trial is to determine the proportion of eligible patients randomized in an 18-month period. The primary feasibility outcome will be to (1) stop, main study not feasible: estimated proportion of randomized patients <40.0% (40/100); (2) continue with protocol modifications: estimated proportion of randomized patients 40.0% (40/100) to 59.0% (50/100); or (3) continue without modification: estimated proportion of randomized patients ?60.0% (60/100). The secondary objectives are to evaluate compliance with the nutritional supplements and to estimate differences in postoperative complications, global health-related quality of life (QoL), and median length of hospital stay between the groups. METHODS:This is a double-blind randomized placebo-controlled feasibility trial. The intervention comprises three nutritional supplements: a protein isolate powder (ISOlution); immunomodulation (INergy-FLD), formulated liquid diet; and carbohydrate loading (PreCovery). Patients will consume 1 serving of the protein supplement per day from the randomization time up to 6 days before surgery (30 days in total). The immunomodulation, a solution that contains arginine, protein isolate, omega-6 fatty acids, and RNA, aims to attenuate excessive inflammatory responses and to replenish nutrients. This solution will be consumed as 3 doses per day for 5 days before and after surgery. Carbohydrate loading helps to reduce the stress from surgery by decreasing insulin resistance. Patients will have 2 servings the evening before surgery and 1 serving 2-3 hours before surgery. To be eligible, patients must have a resectable gastrointestinal cancer for which an elective operation is planned. Patients will be stratified according to nutritional status. The operation should occur within 4 weeks from enrollment. RESULTS:We expect to screen 165 eligible patients; 60.6% (100/165) of them will be randomized to either intervention or placebo. Assuming a two-sided alpha of .05, this will give us a 95% CI around the estimate of 53%-68%. A sample size of 50 per group will enable us to estimate the treatment effect and corresponding variance of the complication rate and QoL measures with adequate precision. The success is defined as the proportion of eligible patients randomized as ?60.0% (60/100). Patients' compliance is defined as an intake of at least 70% (41/58) sachets of the intervention volume. CONCLUSIONS:The results will help to determine the feasibility of a larger randomized controlled trial to implement a perioperative nutritional supplement program for patients undergoing gastrointestinal surgery for cancer. TRIAL REGISTRATION:ClinicalTrials.gov NCT03445260; https://clinicaltrials.gov/ct2/show/NCT03445260 (Archived by WebCite at http://www.webcitation.org/72CAmMzgP). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/10491.

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Perioperative Electroacupuncture Can Accelerate the Recovery of Gastrointestinal Function in Cancer Patients Undergoing Pancreatectomy or Gastrectomy: A Randomized Controlled Trial.

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