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A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP.

ABSTRACT: Visualization during GI endoscopy requires distention of the bowel lumen. Carbon dioxide (CO(2)) insufflation decreases postprocedure abdominal discomfort and distension after colonoscopy, but there have been few published studies on its use in ERCP.To assess the safety and efficacy of CO(2) insufflation during ERCP.Double-blind, controlled, randomized trial.Tertiary-care referral center.This study involved consecutive patients referred for ERCP, excluding those with known CO(2) retention or with chronic use of opiate medications.Insufflation of CO(2) versus insufflation of air.Primary outcomes were abdominal pain assessed on a visual analogue scale and abdominal distension. Secondary outcomes included transcutaneous CO(2) levels (pCO(2)) and procedural complications.We analyzed 74 patients, 38 in the air group and 36 in the CO(2) group. Pain scores were similar in both groups 1-hour postprocedure (16 vs 11 mm in the CO(2) and air groups, respectively; P = .29) as well as over the subsequent 24 hours. There were also no significant differences between groups in abdominal distension or pCO(2) levels. There were 13 patients with complications in the air group and 5 in the CO(2) group (P = .04; nominal significance removed by Bonferroni correction), although most complications were minor in nature.Single-center study.The use of CO(2) for insufflation during ERCP was safe in a tertiary-care referral population. However, use of CO(2) during ERCP did not lead to decreased postprocedural pain or less abdominal distension, so its role in this procedure remains in question. NCT00685386.

SUBMITTER: Dellon ES

PROVIDER: S-EPMC2902617 | biostudies-literature | 2010 Jul

REPOSITORIES: biostudies-literature

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A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP.

Dellon Evan S ES Velayudham Arumugam A Clarke Bridger W BW Isaacs Kim L KL Gangarosa Lisa M LM Galanko Joseph A JA Grimm Ian S IS

Gastrointestinal endoscopy 20100520 1

<h4>Background</h4>Visualization during GI endoscopy requires distention of the bowel lumen. Carbon dioxide (CO(2)) insufflation decreases postprocedure abdominal discomfort and distension after colonoscopy, but there have been few published studies on its use in ERCP.<h4>Objective</h4>To assess the safety and efficacy of CO(2) insufflation during ERCP.<h4>Design</h4>Double-blind, controlled, randomized trial.<h4>Setting</h4>Tertiary-care referral center.<h4>Patients</h4>This study involved cons ...[more]

PMID: 20493485

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Project description:BackgroundCarbon dioxide (CO2) insufflation is increasingly used for endoscopic submucosal dissection (ESD) owing to the faster absorption of CO2 as compared to that of air. Studies comparing CO2 insufflation and air insufflation have reported conflicting results.ObjectivesThis meta-analysis is aimed to assess the efficacy and safety of use of CO2 insufflation for ESD.MethodsClinical trials of CO2 insufflation versus air insufflation for ESD were searched in PubMed, Embase, the Cochrane Library and Chinese Biomedical Literature Database. We performed a meta-analysis of all randomized controlled trials (RCTs).ResultsEleven studies which compared the use of CO2 insufflation and air insufflation, with a combined study population of 1026 patients, were included in the meta-analysis (n = 506 for CO2 insufflation; n = 522 for air insufflation). Abdominal pain and VAS scores at 6h and 24h post-procedure in the CO2 insufflation group were significantly lower than those in the air insufflation group, but not at 1h and 3h after ESD. The percentage of patients who experienced pain 1h and 24h post-procedure was obviously decreased. Use of CO2 insufflation was associated with lower VAS scores for abdominal distention at 1h after ESD, but not at 24h after ESD. However, no significant differences were observed with respect to postoperative transcutaneous partial pressure carbon dioxide (PtcCO2), arterial blood carbon dioxide partial pressure (PaCO2), oxygen saturation (SpO2%), abdominal circumference, hospital stay, white blood cell (WBC) counts, C-Reactive protein (CRP) level, dosage of sedatives used, incidence of dysphagia and other complications.ConclusionUse of CO2 insufflation for ESD was safe and effective with regard to abdominal discomfort, procedure time, and the residual gas volume. However, there appeared no significant differences with respect to other parameters namely, PtcCO2, PaCO2, SpO2%, abdominal circumference, hospital stay, sedation dosage, complications, WBC, CRP, and dysphagia.

Project description:Would letrozole as a primary ovulation induction agent generate better pregnancy rates than clomiphene citrate (CC) in subfertile women with anovulatory polycystic ovarian syndrome (PCOS)?Participants receiving letrozole as a primary treatment achieved a significantly (P = 0.022) higher clinical pregnancy rate per patient (61.2%) compared to CC (43.0%).According to a recent Cochrane systematic review (2014), letrozole appears to improve live-birth (LB) and pregnancy rates in anovulatory women with PCOS, compared to CC. However, the review concluded that the quality of evidence was low due to poor reporting of study methods and possible publication bias.This double-blind randomized controlled trial (RCT) included 159 participants between April 2007 and June 2014. Subjects were randomly allocated to either CC (n = 79) or letrozole (n = 80) in a 1:1 ratio. Both drugs were encapsulated to look identical. Randomization was performed in mixed blocks and stratified by patients' BMI (<30 and 30-35 kg/m2).The trial included subfertile women diagnosed with PCOS. Treatment started with one tablet (CC 50 mg, letrozole 2.5 mg) increasing to two in non-responders and continuing until pregnancy or for up to six ovulatory cycles. Non-responders were crossed over to the other treatment after a 6-week break. Cycles were initially monitored with ultrasound follicle tracking then mid-luteal serum progesterone measurement in subsequent cycles.Amongst the 159 participants included in the intention-to-treat analysis, four women conceived before treatment and six were lost-to-follow-up. The remaining 149 participants (74 on CC and 75 on letrozole) completed at least the first treatment. Women receiving letrozole achieved a significantly (P = 0.022; absolute difference [95% confidence interval] 18% [3-33%]) higher pregnancy rate (61.%) than those on CC (43%). The median number of treatment cycles received until pregnancy was significantly (log rank P = 0.038) smaller with letrozole (4[3-5] cycles) compared to CC (6[4-7] cycles). LB rates were not statistically (P = 0.089) different between the two groups, although there was a trend towards higher rates on letrozole (48.8%) compared to CC (35.4%). After the crossover, pregnancy and LB rates on letrozole (n = 45; 28.9 and 24.4%, respectively) were not statistically (P = 0.539 and P = 0.601) different from CC (n = 31; 22.6 and 19.4%).One possible limitation of this trial may be the exclusion of PCOS women with BMI > 35 kg/m2, which would limit the applicability of the results in this subgroup of PCOS. However, this group of women are generally excluded from treatment in the majority of fertility centres, especially in Europe, due to the associated challenges and risks.The results of this trial are consistent with the recent Cochrane systematic review. However, with its robust design, the current RCT provides more valid and compelling evidence for the superiority of letrozole over CC as a primary ovulation induction agent in PCOS women with 40% increase in pregnancy rates and with a shorter time-to-pregnancy. Furthermore, the participants in this RCT are a good representation of subfertile PCOS population receiving fertility treatment in Europe and worldwide. The results are therefore globally generalizable for clinical practice.This RCT was mainly funded by the R&D Funding Scheme of Derby Hospitals NHS Foundation Trust. The study also received funds from School of Medicine, University of Nottingham. The Trust R&D department was involved in the development of the protocol and the running of the trial. The trial was sponsored and monitored by the University of Nottingham. The authors have no conflicts of interest.www.Clinicaltrials.gov: NCT00478504.Registration was verified on 23/05/2007.25/04/2007.

Project description:BACKGROUND:Animal studies have shown that peritoneal injury can be minimized by insufflating the abdominal cavity with warm humidified carbon dioxide gas. METHODS:A single-blind RCT was performed at a tertiary colorectal unit. Inclusion criteria were patient aged 18?years and over undergoing open elective surgery. The intervention group received warmed (37°C), humidified (98 per cent relative humidity) carbon dioxide (WHCO2 group). Multiple markers of peritoneal inflammation and oxidative damage were used to compare groups, including cytokines and chemokines, apoptosis, the 3-chlorotyrosine/native tyrosine ratio, and light microscopy on peritoneal biopsies at the start (T0 ) and end (Tend ) of the operation. Postoperative clinical outcomes were compared between the groups. RESULTS:Of 40 patients enrolled, 20 in the WHCO2 group and 19 in the control group were available for analysis. A significant log(Tend /T0 ) difference between control and WHCO2 groups was documented for interleukin (IL) 2 (5·3 versus 2·8 respectively; P = 0·028) and IL-4 (3·5 versus 2·0; P = 0·041), whereas apoptosis assays documented no significant change in caspase activity, and similar apoptosis rates were documented along the peritoneal edge in both groups. The 3-chlorotyrosine/tyrosine ratio had increased at Tend by 1·1-fold in the WHCO2 group and by 3·1-fold in the control group. Under light microscopy, peritoneum was visible in 11 of 19 samples from the control group and in 19 of 20 samples from the WHCO2 group (P = 0·006). The only difference in clinical outcomes between intervention and control groups was the number of days to passage of flatus (2·5 versus 5·0?days respectively; P = 0·008). CONCLUSION:The use of warmed, humidified carbon dioxide appears to reduce some markers related to peritoneal oxidative damage during laparotomy. No difference was observed in clinical outcomes, but the study was underpowered for analysis of surgical results. Registration number: NCT02975947 ( www.ClinicalTrials.gov/).

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A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP.

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A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP.

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