The effectiveness of adding Braun anastomosis to Standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): a multicenter randomized-controlled trial.
Recruiting
- Conditions
- pancreas cancerpancreas head carcinoma1001799010017998
- Registration Number
- NL-OMON56185
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 256
Inclusion Criteria
• undergoing open pancreatoduodenectomy
• provided informed consent
• age over 18 years
Exclusion Criteria
• insufficient control of the Dutch language to read the patient information
and to fill out the questionnaires in Dutch hospitals
• insufficient control of the Italian language to read the patient information
and to fill out the questionnaires in Italian hospitals
• Previous bariatric surgery (such as Roux-en-Y gastric bypass, gastric sleeve)
• Pregnancy
• Bowel motility disorders
• Minimally invasive pancreatoduodenectomy
• Gastric outlet obstruction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of DGE Grade B/C (according to International Study Group of<br /><br>Pancreatic Surgery (ISGPS) )</p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence of postoperative pancreatic fistulas (POPF) Grade B/C (according to<br /><br>ISGPS), anastomotic leak (HJ, BE), complications, hospital length of stay,<br /><br>functional outcome at 12 months, in-hospital mortality, 30-day mortality.<br /><br>Healthcare costs.</p><br>