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Trial Title:
Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy
NCT ID:
NCT00906802
Condition:
Pancreatic Cancer
Conditions: Keywords:
pancreaticoduodenectomy
reconstruction
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
R-Y reconstruction
Description:
The reconstruction was performed by R-Y anastomosis.
Arm group label:
R-Y reconstruction
Other name:
the cutting R-Y anastmosis
Summary:
One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric
emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in
prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined
as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a
regular diet after POD 14. The incidence of DGE has been reported to range from 5% to
72%.
Detailed description:
We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce
anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- These patients were to undergo elective pancreatic head resection for the treatment
of periampullary mass
Exclusion Criteria:
- A body weight loss greater than 10% during the six months prior to surgery
- The presence of distant metastases
- Seriously impaired function of vital organs due to respiratory, renal or heart
disease
Gender:
All
Minimum age:
30 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kochi Medical School
Address:
City:
Nankoku
Zip:
783-8505
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Takehiro Okabayashi, MD, PhD
Phone:
81-88-880-2370
Email:
tokabaya@kochi-u.ac.jp
Contact backup:
Last name:
Kazuhiro Hanazaki, Prof
Phone:
81-88-880-2370
Email:
im31@kochi-u.ac.jp
Start date:
April 2003
Completion date:
April 2010
Lead sponsor:
Agency:
Kochi University
Agency class:
Other
Source:
Kochi University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00906802