Laparoscopic Heller Myotomy and Fundoplication: What Is the Evidence?

2018 ◽  
Vol 84 (4) ◽  
pp. 481-488 ◽  
Author(s):  
Fabrizio Rebecchi ◽  
Marco E. Allaix ◽  
Francisco Schlottmann ◽  
Marco G. Patti ◽  
Mario Morino
Keyword(s):  
Heller Myotomy ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Laparoscopic Heller Myotomy ◽  
Current Evidence ◽  
Partial Fundoplication ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Total Fundoplication ◽  
Significant Difference

There is no agreement about the best type of fundoplication to add in patients undergoing laparoscopic Heller myotomy (LHM) for achalasia to reduce the risk of postoperative gastroesophageal reflux. This article reviews the current evidence about the outcomes in achalasia patients undergoing LHM with a partial anterior, a partial posterior, or a total fundoplication. We performed a review of the literature in PubMed/Medline electronic databases, which was evaluated according to the GRADE system. The results of the published randomized controlled trials show with a high level of evidence that the addition of a fundoplication reduces the risk of postoperative abnormal reflux, without impairing the food emptying of the esophagus. LHM with partial fundoplication is considered in most centers worldwide the standard of care for the treatment of patients with achalasia. The current evidence fails to show any significant difference between partial anterior and posterior fundoplication. In the absence of further large randomized controlled trial, the decision of performing an anterior or a posterior wrap is based on the surgeon's experience and preference. The addition of a partial fundoplication to LHM leads to a significantly lower rate of postoperative pathological reflux without impairing the esophageal emptying.

scholarly journals Randomized Controlled Trial of Botulinum Toxin Versus Laparoscopic Heller Myotomy for Esophageal Achalasia

2004 ◽  
Vol 239 (3) ◽  
pp. 364-370 ◽  
Author(s):  
Giovanni Zaninotto ◽  
Vito Annese ◽  
Mario Costantini ◽  
Alberto Del Genio ◽  
Michela Costantino ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Botulinum Toxin ◽  
Heller Myotomy ◽  
Controlled Trial ◽  
Esophageal Achalasia ◽  
Laparoscopic Heller Myotomy ◽  
Randomized Controlled

Randomized Controlled Trial of Topical Skin Adhesive vs Nylon Sutures for Incision Closure in Forefoot Surgery

2021 ◽  
pp. 107110072110025
Author(s):  
Thomas L. Lewis ◽  
Thomas A. J. Goff ◽  
Robbie Ray ◽  
C. Ruth Varrall ◽  
Peter W. Robinson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Satisfaction ◽  
Wound Closure ◽  
Wound Care ◽  
Controlled Trial ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Forefoot Surgery ◽  
Significant Difference ◽  
Patient Reported

Background: There are many options for incision closure in forefoot surgery. The aim of this study was to compare topical skin adhesive (2-octyl-cyanoacrylate) to simple interrupted nylon sutures. Methods: A prospective randomized controlled trial comparing topical skin adhesive (TSA) and nylon sutures (NSs) for elective open forefoot surgery. Primary outcome was Hollander Wound Evaluation Scale (HWES) assessed 2 weeks following surgery. Secondary objectives included time taken for wound closure, wound assessment, patient satisfaction with wound cosmesis, incision pain, and infection rate. Results: Between January and December 2018, 84 feet (70 patients) underwent hallux valgus scarf/Akin osteotomy or first metatarsophalangeal arthrodesis and were randomized to receive either intervention (topical skin adhesive) or control (3/0 nylon sutures). We found worse HWES scores when using TSA compared to NSs (1.07 vs 0.60). Incision closure time was slower for TSA (mean, 272 vs 229 seconds). At 2 weeks postoperatively, wound care was faster for TSA (mean 71 secs) vs NSs (mean 120), and patient-reported pain was less with TSA (visual analog scale: TSA 1.2 vs NSs 2.1). A high degree of overall patient satisfaction was reported in both groups, without significant difference. Conclusion: Closure of elective forefoot surgery incisions with topical skin adhesive or interrupted nylon sutures offers high satisfaction rates, low pain scores, and low complications. However, topical skin adhesive was associated with more inflammation and areas of wound separation compared to nylon sutures. We recommend the use of sutures for wound closure in forefoot surgery. Level of Evidence: Level I, randomized controlled trial.

scholarly journals LO43: Does point of care ultrasound improve resuscitation markers in emergency department patients with undifferentiated hypotension? The first Sonography in Hypotension and Cardiac Arrest in the Emergency Department (SHOC-ED 1) Study; an international randomized controlled trial

CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S42
Author(s):  
L. Taylor ◽  
J. Milne ◽  
D. Lewis ◽  
L. Diegelmann ◽  
H. Lamprecht ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Point Of Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Volume Of Fluid ◽  
Point Of Care Ultrasound ◽  
Shock Index ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Point of Care Ultrasound (PoCUS) protocols are commonly used to guide resuscitation for emergency department (ED) patients with undifferentiated non-traumatic hypotension. While PoCUS has been shown to improve early diagnosis, there is a minimal evidence for any outcome benefit. We completed an international multicenter randomized controlled trial (RCT) to assess the impact of a PoCUS protocol on key resuscitation markers in this group. We report diagnostic impact and mortality elsewhere. Methods: The SHoC-ED1 study compared the addition of PoCUS to standard care within the first hour in the treatment of adult patients presenting with undifferentiated hypotension (SBP<100 mmHg or a Shock Index >1.0) with a control group that did not receive PoCUS. Scans were performed by PoCUS-trained physicians. 4 North American, and 3 South African sites participated in the study. Resuscitation outcomes analyzed included volume of fluid administered in the ED, changes in shock index (SI), modified early warning score (MEWS), venous acid-base balance, and lactate, at one and four hours. Comparisons utilized a T-test as well as stratified binomial log-regression to assess for any significant improvement in resuscitation amount the outcomes. Our sample size was powered at 0.80 (α:0.05) for a moderate effect size. Results: 258 patients were enrolled with follow-up fully completed. Baseline comparisons confirmed effective randomization. There was no significant difference in mean total volume of fluid received between the control (1658 ml; 95%CI 1365-1950) and PoCUS groups (1609 ml; 1385-1832; p=0.79). Significant improvements were seen in SI, MEWS, lactate and bicarbonate with resuscitation in both the PoCUS and control groups, however there was no difference between groups. Conclusion: SHOC-ED1 is the first RCT to compare PoCUS to standard of care in hypotensive ED patients. No significant difference in fluid used, or markers of resuscitation was found when comparing the use of a PoCUS protocol to that of standard of care in the resuscitation of patients with undifferentiated hypotension.

A randomized controlled trial comparing ketorolac and triamcinolone injections in adults with trigger digits

2018 ◽  
Vol 43 (9) ◽  
pp. 936-941 ◽  
Author(s):  
Mabel Qi He Leow ◽  
Aik Siew Robyn Hay ◽  
Shu Li Ng ◽  
Muntasir Mannan Choudhury ◽  
Huihua Li ◽  
...  
Keyword(s):  
Complete Resolution ◽  
Controlled Trial ◽  
Flexion Deformity ◽  
Short Term ◽  
Level Of Evidence ◽  
Active Motion ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Total Active Motion ◽  
To Receive

We assessed the efficacy of ketorolac trometamol injections compared with triamcinolone acetonide injections in trigger digits. Patients with trigger digits were randomized to receive either ketorolac or triamcinolone. They were followed up at 3, 6, 12 and 24 weeks, and monitored for resolution of triggering, pain and total active motion. One hundred and twenty-one patients with single trigger digits were recruited (59 ketorolac, 62 triamcinolone). At 6 weeks, 54% of patients in the triamcinolone group had complete resolution of trigger, whereas no patients in the ketorolac group had resolution. At 12 weeks, 58% of patients in the triamcinolone group had complete resolution of trigger compared with 6.7% in the ketorolac group. At 24 weeks, both groups had comparable rates of resolution at 26% and 25%, respectively. Patients in the triamcinolone group had significantly better resolution of pain at 3, 6 and 12 weeks. But at 24 weeks, there was no significant difference in pain between both groups. Significantly less flexion deformity was reported at 3 weeks and 6 weeks in the triamcinolone group. In the short term, ketorolac was less effective in relieving symptoms of trigger digit than triamcinolone. Level of evidence: I

scholarly journals Efficacy of High-Dose Polyclonal Intravenous Immunoglobulin in COVID-19: A Systematic Review

Vaccines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 94
Author(s):  
Daniele Focosi ◽  
Massimo Franchini ◽  
Marco Tuccori ◽  
Mario Cruciani
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Intravenous Immunoglobulin ◽  
Standard Of Care ◽  
Current Evidence ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Significant Difference

Background: Although several therapeutic strategies have been investigated, the optimal treatment approach for patients with coronavirus disease (COVID-19) remains to be elucidated. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of polyclonal intravenous immunoglobulin (IVIG) therapy in COVID-19. Methods: A systematic literature search using appropriate medical subject heading (MeSH) terms was performed through Medline (PubMed), EMBASE, SCOPUS, OVID and Cochrane Library electronic databases. The main outcomes considered were mortality and safety of IVIG versus placebo/standard of care. This review was carried out in accordance with Cochrane methodology including the risk bias assessment and grading of the quality of evidence. Measures of treatment effect were mean differences (MD) together with 95% confidence intervals (CIs) for continuous outcome measures and risk ratio (RR) or MD for binary outcomes. Two reviewers independently extracted data from individual studies, and disagreements were resolved by a third reviewer. Results: A total of 2401 COVID-19 patients from 10 studies (four randomized controlled trials (RCT) and six non-randomized controlled trials (non-RCTs)) were included in the analysis. Participants received IVIG or placebo/standard of care. The use of IVIG was not associated with a significantly reduced risk of death (RR 0.50, 95% CIs 0.18–1.36, p = 0.17 for RCTs; RR 0.95, 95% CIs 0.61–1.58, p = 0.94 for non-RCTs; low certainty of evidence). IVIG significantly reduced the length of hospital stay (MD −2.24, 95% CIs −3.20/−1.27; p = 0.00001; low certainty of evidence), although this difference was significant only for studies evaluating moderate COVID-19 patients. No significant difference was observed in the incidence of overall and serious adverse events between IVIG recipients and controls (very low certainty of evidence). Conclusions: The current evidence from the literature does not support the use of IVIG in COVID-19 patients.

Microbial counts in hands with and without nail varnish after surgical skin preparation: a randomized control trial

2018 ◽  
Vol 43 (8) ◽  
pp. 832-835 ◽  
Author(s):  
Vinay Kulkarni ◽  
Anthony Murray ◽  
Rajat Mittal ◽  
David Spence ◽  
Gabrielle O’Kane ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Level Of Evidence ◽  
Skin Preparation ◽  
Microbial Counts ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Randomized Control ◽  
Lost To Follow Up ◽  
Nail Varnish

Nail varnish is commonly removed from fingernails prior to surgical procedures. We report the results of a randomized controlled trial comparing the microbial counts in hands with and without nail varnish applied, following surgical skin preparation. Forty-three patients were randomized; three patients were lost to follow-up. Each patient had one hand painted with nail varnish and had both hands tested 1 week later. There was no significant difference in terms of positive microbial growth between the nail plates or hyponichia with or without nail varnish applied. Our results demonstrate that the presence of nail varnish does not have an effect on the microbial counts of hands following surgical skin preparation. Level of evidence: I

Dor Vs Toupet Fundoplication After Laparoscopic Heller Myotomy: Long-Term Randomized Controlled Trial Evaluated by High-Resolution Manometry

2017 ◽  
Vol 22 (1) ◽  
pp. 13-22 ◽  
Author(s):  
Gonzalo Torres-Villalobos ◽  
Enrique Coss-Adame ◽  
Janette Furuzawa-Carballeda ◽  
Fernanda Romero-Hernández ◽  
Blanca Blancas-Breña ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Resolution ◽  
Heller Myotomy ◽  
Controlled Trial ◽  
Laparoscopic Heller Myotomy ◽  
Toupet Fundoplication ◽  
High Resolution Manometry ◽  
Randomized Controlled
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