scholarly journals The first randomized controlled trial on early versus late oral feeding after minimally invasive esophagectomy and the ongoing quest for more evidence

2017 ◽  
Vol 9 (10) ◽  
pp. 3635-3637
Author(s):  
Miguel A. Cuesta
Keyword(s):  
Randomized Controlled Trial ◽  
Minimally Invasive ◽  
Controlled Trial ◽  
Minimally Invasive Esophagectomy ◽  
Oral Feeding ◽  
Invasive Esophagectomy ◽  
Randomized Controlled

382 INTRATHORACIC VERSUS CERVICAL ANASTOMOSIS AFTER MINIMALLY INVASIVE ESOPHAGECTOMY FOR OESOPHAGEAL CANCER: A RANDOMIZED CONTROLLED TRIAL (ICAN TRIAL)

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Moniek Verstegen ◽  
Frans Workum ◽  
Bastiaan Klarenbeek ◽  
Stefan Bouwense ◽  
Suzanne Gisbertz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Minimally Invasive ◽  
Controlled Trial ◽  
Minimally Invasive Esophagectomy ◽  
Secondary Outcome ◽  
Ivor Lewis ◽  
Invasive Esophagectomy ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Robust Evidence

Abstract   Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (RR 0.39, 95%CI 0.22–0.65). Severe complications (Clavien-Dindo ≥3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE (RR 0.49, 95%CI 0.25–0.88). Conclusion This study provides evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer.

Intrathoracic versus cervical anastomosis after minimally invasive esophagectomy for esophageal cancer: A randomized controlled trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4509-4509
Author(s):  
Moniek Verstegen ◽  
Frans van Workum ◽  
Bastiaan Klarenbeek ◽  
Suzanne Gisbertz ◽  
Gerjon Hannink ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Minimally Invasive ◽  
Controlled Trial ◽  
Minimally Invasive Esophagectomy ◽  
Secondary Outcome ◽  
Ivor Lewis ◽  
Invasive Esophagectomy ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

4509 Background: Robust evidence is lacking whether Ivor Lewis minimally invasive esophagectomy (MIE) or McKeown MIE should be preferred for patients with mid to distal esophageal or gastro-esophageal junction Siewert I-II (GEJ) cancer. Methods: In this multicenter randomized controlled trial, patients with esophageal (below the level of the carina) or GEJ cancer planned for curative resection were recruited. Eligible patients were randomly assigned (1:1) to either Ivor Lewis MIE or McKeown MIE. The primary endpoint was anastomotic leakage (AL) requiring endoscopic, radiologic or surgical intervention. Secondary outcome parameters were overall AL rate, postoperative complications, length of stay and mortality. Results: A total of 262 patients were randomly assigned to Ivor Lewis MIE (n = 130) or McKeown MIE (n = 132). Seventeen patients were excluded from the trial due to not meeting inclusion criteria (n = 2), physical unfitness for surgery (n = 3), patients’ choice (n = 3), interval metastases (n = 5) or peroperative metastases (n = 4). AL necessitating reintervention occurred in 15 (12.3%) of 122 patients after Ivor Lewis MIE and in 39 (31.7%) of 123 patients after McKeown MIE (relative risk 0.39, 95% CI 0.22-0.65; risk difference 19.4%, 95% CI 7.9%-31.8%). Overall AL rate was 12.3% after Ivor Lewis MIE and 34.1% after McKeown MIE. Severe complications (Clavien-Dindo ≥ 3b) were observed in 10.7% after Ivor Lewis MIE and in 22.0% after McKeown MIE. Pleural effusion requiring drainage occurred in 9.8% of patients after Ivor Lewis MIE and 21.1% of patients after McKeown MIE. RLN palsy rate was 0% after Ivor Lewis MIE and 7.3% after McKeown MIE. Median length of hospital stay was 10 days (IQR 8 – 15 days) after Ivor Lewis MIE and 12 days (IQR 9 – 18 days) after McKeown MIE. ICU length of stay and mortality rates were comparable between groups. Conclusions: These findings provide evidence for a lower rate of AL requiring reintervention after Ivor Lewis MIE compared to McKeown MIE for patients with mid to distal esophageal or GEJ cancer. Clinical trial information: NTR4333 .

scholarly journals iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sarah Edwards ◽  
Paul E. Hyman ◽  
Hayat Mousa ◽  
Amanda Bruce ◽  
Jose Cocjin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Tube Feeding ◽  
Parent Stress ◽  
Oral Feeding ◽  
Child Quality ◽  
Randomized Controlled ◽  
Tube Weaning

Abstract Background Although tube feeding routinely saves the lives of children who do not eat by mouth, chronic tube feeding can be a burden to patients, caregivers, and families. Very few randomized trials exist regarding the best methods for weaning children from their feeding tubes. Methods The current paper describes a randomized controlled trial of an empirically supported outpatient treatment protocol for moving children from tube to oral eating called iKanEat. Specifically, we describe the methods of randomized double-blind, placebo-controlled trial which includes a 4-week course of megestrol, the only medication used in the iKanEat protocol, to determine whether the addition of megestrol results in improved child outcomes. The primary and secondary aims are to assess the safety and efficacy of megestrol as part of the iKanEat protocol. The third aim is to provide critical information about the impact of the transition from tube to oral feeding on parent stress and parent and child quality of life. Discussion This trial will provide data regarding whether megestrol is a safe and effective component of the iKanEat tube weaning protocol, as well as important data on how the tube weaning process impacts parent stress and parent and child quality of life. Trial registration ClinicalTrials.gov NCT#03815019. Registered on January 17, 2019

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