To assess the effectiveness of adding BE in reducing DGE in patients undergoing open pancreatoduodenectomy.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of DGE Grade B/C (according to International Study Group of
Pancreatic Surgery (ISGPS) )
Secondary outcome
Incidence of postoperative pancreatic fistulas (POPF) Grade B/C (according to
ISGPS), anastomotic leak (HJ, BE), complications, hospital length of stay,
functional outcome at 12 months, in-hospital mortality, 30-day mortality.
Healthcare costs.
Background summary
The addition of Braun enteroenterostomy reduces the incidence of delayed
gastric emptying (DGE) resulting in lower morbidity and healthcare costs after
pancreatoduodenectomy.
Study objective
To assess the effectiveness of adding BE in reducing DGE in patients undergoing
open pancreatoduodenectomy.
Study design
A multicenter, patient and observer blinded, registry-based randomized-
controlled trial.
Intervention
Braun enteroenterostomy (BE), or Braun anastomosis, in addition to usual care.
Study burden and risks
Patients undergoing open pancreatoduodenectomy have an increased risk of
postoperative complications such as DGE, POPF and anastomotic leak. The
addition of BE, which is an anastomosis, could also result in a leak. However,
this risk is diminishable compared to the risks of DGE and DGE related other
complications like HJ and PJ anastomotic leaks associated with standard
pancreatoduodenectomy. Moreover, previous cohort studies involving BE do not
describe an increased risk of adverse outcomes for BE.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82918.091.22 |