Central pancreatectomy combined with end-to-end anastomosis reconstruction versus conventional central pancreatectomy in robotic surgery: study protocol for a randomized clinical trial

2019 ◽  
Author(s):  
LIN ZHU ◽  
Gong Zhang ◽  
Jizhe Li ◽  
Haifeng Zhang ◽  
Fei Huang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Robotic Surgery ◽  
Pancreatic Fistula ◽  
Randomized Clinical Trial ◽  
Exocrine Function ◽  
Complication Rates ◽  
Central Pancreatectomy ◽  
Pancreatic Neck ◽  
Malignant Lesions ◽  
End To End

Abstract [EXSCINDED] Abstract Abstract Background Central pancreatectomy (CP) is an ideal surgery option for benign and low malignant potential lesions in the neck and body of pancreas. CP maintains pancreatic endocrine and exocrine function better than distal pancreatectomy and pancreaticoduodenectomy, but it has a higher risk of pancreatic fistula1. Up to now, CP reported by Dagradi and Serio2 is the standard procedure. But our four-year experience suggests CP with end-to-end anastomosis could reduce pancreatic fistula and other complication rates. The aim of the trial is to investigate whether the CP combined with end-to-end anastomosis reconstruction approach can reduce the fistula rate of patients with pancreatic neck and body benign and low malignant lesions compared with the conventional approach. We hypothesize that CP combined with end-to-end anastomosis could be an alternative procedure of conventional CP.Methods/design The trial is a single center, randomized controlled trial with two parallel research group. The trial compares the possible advantages of CP combined with end-to-end anastomosis to conventional CP in robotic surgery. One hundred and seventy patients with pancreatic neck and body benign and low malignant lesions in Chinese People’s Liberation Army (PLA) General Hospital will be enrolled. The patients will be divided into two groups randomly. One group will choose CP with end-to-end anastomosis while the other group will use conventional CP. The primary endpoint will be postoperative pancreatic fistula (POPF) rate.Discussion There is no randomized clinical trial to estimate the advantages of CP with end-to-end anastomosis reconstruction. The CP with end-to-end anastomosis reconstruction in robotic surgery was first reported by Professor Liu in our department, and professional surgical techniques can reduce confounding factors and have high recruitment rate. For our research is a randomized clinical trial, we can provide high quality evidence on CP standard.

scholarly journals Randomized clinical trial of acetazolamide administration and/or prone positioning in mitigating wound complications following untethering surgeries

2016 ◽  
Vol 17 (6) ◽  
pp. 659-666 ◽  
Author(s):  
Shima Shahjouei ◽  
Sara Hanaei ◽  
Zohreh Habibi ◽  
Mostafa Hoseini ◽  
Saeed Ansari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Wound Repair ◽  
Wound Dehiscence ◽  
Complication Rates ◽  
Prone Positioning ◽  
Csf Leakage ◽  
Group A ◽  
Group B ◽  
Group D

OBJECTIVE No evidence-based guideline has been approved for the postoperative management of pediatric patients with tethered cord syndrome (TCS). The purpose of this randomized clinical trial was to evaluate the effectiveness of prone positioning and acetazolamide administration on complication rates following spinal cord untethering surgeries. METHODS From October 2012 to February 2015, patients with a primary diagnosis of TCS who were admitted to the Children's Medical Center Hospital of Iran were randomly allocated to 1 of 4 intervention modality groups postoperatively: 1) Group A, acetazolamide administration for 10 days; 2) Group B, prone positioning for 10 days; 3) Group C, acetazolamide administration and prone positioning for 10 days; and 4) Group D, no intervention. CSF leakage, CSF collection, wound dehiscence, operative site infection, and secondary surgical wound repair were considered failure. RESULTS A total of 161 patients were enrolled in this study (Group A, n = 39 [24.2%]; Group B, n = 41 [25.5%]; Group C, n = 39 [24.2%]; and Group D, n = 42 [26.1%]). The overall failure rate was 12.42% (20 patients). Complication rates through pooled analyses were as follows: CSF leakage (n = 9, 5.6%), CSF collection (n = 12, 7.5%), wound dehiscence (n = 2, 1.2%), and infection of operation site (n = 3, 1.9%). Two patients (1.2%) required surgical secondary wound repair due to complications. CSF leakage and collection rates were significantly lower in patients who underwent prone positioning (p = 0.042 and 0.036, respectively). The administration of acetazolamide, either isolated or in combination with prone positioning, not only could not significantly lower the complication rates, but also added the burden of side effects. CONCLUSIONS The current study demonstrates the possible role of prone positioning in mitigating the complication rates subsequent to untethering surgeries. Clinical trial registration no.: NCT01867268 (clinicaltrials.gov)

Randomized clinical trial of pancreaticogastrostomyversuspancreaticojejunostomy on the rate and severity of pancreatic fistula after pancreaticoduodenectomy

2013 ◽  
Vol 100 (12) ◽  
pp. 1597-1605 ◽  
Author(s):  
J. Figueras ◽  
L. Sabater ◽  
P. Planellas ◽  
E. Muñoz-Forner ◽  
S. Lopez-Ben ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pancreatic Fistula ◽  
Randomized Clinical Trial

scholarly journals Randomized clinical trial of the effect of a fibrin sealant patch on pancreatic fistula formation after pancreatoduodenectomy

2018 ◽  
Vol 105 (7) ◽  
pp. 811-819 ◽  
Author(s):  
M. Schindl ◽  
R. Függer ◽  
P. Götzinger ◽  
F. Längle ◽  
M. Zitt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pancreatic Fistula ◽  
Randomized Clinical Trial ◽  
Fibrin Sealant ◽  
Fistula Formation

scholarly journals Clinical Outcomes and Safety of Passive Leg Raising in Out-of-Hospital Cardiac Arrest. A Randomized Clinical Trial.

2021 ◽  
Author(s):  
Youcef Azeli ◽  
Alfredo Bardají ◽  
Eneko Barbería ◽  
Vanesa Lopez-Madrid ◽  
Jordi Bladé-Creixenti ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Arrest ◽  
Adverse Effects ◽  
Randomized Clinical Trial ◽  
Hospital Discharge ◽  
Passive Leg Raising ◽  
Control Group ◽  
Complication Rates ◽  
X Rays ◽  
Hospital Cardiac Arrest

Abstract Background: There are data suggesting that passive leg raising (PLR) improves hemodynamics during cardiopulmonary resuscitation (CPR). This trial aimed to determine the effectiveness and safety of PLR during CPR in out-of-hospital cardiac arrest (OHCA).Methods: We conducted a randomized clinical trial with blinded assessment of the outcomes that assigned adults OHCA to be treated with PLR or in the flat position. The trial was conducted in the Camp de Tarragona region. The main end point was survival to hospital discharge with good neurological outcome defined as Cerebral Performance Category (CPC 1-2). To study possible adverse effects, we assessed the presence of pulmonary complications on the first chest X-rays in survivors and lungs weight from autopsies in non-survivors. Results: In total, 445 randomized CPR attempts were included, 234 were treated with PLR and 211 were controls. Overall, 71.5% were men and the median age was 69 IQR (58-78) years old. At hospital discharge, 4.3% in the PLR group and 4.7% in the control group were alive with CPC 1-2 (OR 0.9; 95% CI 0.4-2.2, p=0.81). A higher survival at hospital admission was found among patients with a shockable rhythm, but there were no significant differences (OR 1.6; 95% CI 0.8-3.4, p=0.18). There were no differences in pulmonary complication rates in chest X-rays (25.9% vs 17.9%, p=0.47) or lung weight 1223 IQR (909.5-1500) mg vs. 1239 IQR (900-1507) mg. Conclusion: In this trial, PLR during CPR did not improve survival to hospital discharge with CPC 1-2. No evidence of adverse effects has been found.Clinical Trial Registration: ClinicalTrials.gov: NCT01952197, registration date: Sept 27, 2013, https://clinicaltrials.gov/ct2/show/NCT01952197.

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