Non-placement versus placement of a drainage tube around the cervical anastomosis in McKeown esophagectomy: study protocol for a randomized controlled trial

The objective of this study is to evaluate the postoperative anastomotic leakage rate, duration to oral intake, hospital stay, and analgesic use with nonplacement of a cervical drainage tube as an alternative to placement of a cervical drainage tube.MethodsThis is an investigator-initiated, investigator-driven, open-label, randomized controlled parallel-group, noninferiority trial. All adult patients (aged  ≥20 and ≤85 years) with histologically proven, surgically resectable (cT1–3 N0–3 M0) squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid squamous cell carcinoma of the intrathoracic esophagus, and European Clinical Oncology Group performance status 0, 1, or 2 are asse ssed for eligibility. Patients (n = 110) with resectable esophageal cancer who provide informed consent in the outpatient clinic are randomized to either nonplacement of a cervical drainage tube (n = 55) or placement of a cervical drainage tube (n = 55).The primary outcome is the percentage of Clavien –Dindo grade 2 or higher anastomotic leakage.DiscussionThis is the first randomized controlled trial comparing nonplacement versus placement of a cervical drainage tube during McKeown esophagectomy with regards to the usefulness of a drain for anastomotic leakage. If our hypothesis is correct, nonplacement of a cervical drainage tube will be recommended because it is associated with a similar anastomotic ...
Source: Trials - Category: Research Source Type: clinical trials

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Source: Annals of Hepatology - Category: Gastroenterology Tags: Ann Hepatol Source Type: research
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Source: Annals of Hepatology - Category: Gastroenterology Tags: Ann Hepatol Source Type: research
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Source: Medicina Oral, Patologia Oral y Cirugia Bucal - Category: ENT & OMF Tags: Med Oral Patol Oral Cir Bucal Source Type: research
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Gena Cook learned to swim three months before competing in her first triathlon. She was 40. Not only did she not drown, she finished in the top five in her age group. “It is an example of the challenges I have sought to stretch me, that helped me take the biggest risk of all in starting Navigating Cancer,” she said. “I left behind all the comforts of a secure, well-paying job for the simple reason that I wanted to improve patient care for cancer patients. ” Navigating Cancer, which Cook…
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