Infectious Complications
Conditions
Brief summary
Probiotics combined with enteral nutrition reduces postoperative infectious complications in PD
Interventions
enteral nutrition+Pre-operative + one week post-operative Oral Bifidobacterium bifidum live triple capsule, 4 capsules Oral BID
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients greater than 18 years of age; * Indication for elective pancreaticoduodenal surgery; * Patients who understand the nature of the trial and are willing and able to provide written consent
Exclusion criteria
. Current or recent (within the previous 1 month) use of probiotic-based products or antibiotic therapy medications. Inability to tolerate PD due to cardiopulmonary function and other parameters * Received radiotherapy before surgery * Emergency PD surgery * Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| infectious complication | 30 days after surgery | 1\. Post-operative infections: Surgical site infections (SSI): including surgical incision infections and abdominal cavity infections. (1) incision infection: purulent secretions in the incision and culture of pathogenic bacteria (2) abdominal cavity infection: diagnosis can be made by meeting one of the following criteria: ① postoperative symptoms of systemic infection (fever \> 38 ° C, white blood cell count higher than the upper limit of normal values), accompanied by abdominal distension, abdominal pain, and signs of peritonitis; ② abdominal drainage or puncture drainage fluid is purulent fluid, positive bacteriological culture results; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess in the abdominal cavity; ③ ultrasound, CT and other imaging tests or re-operation to confirm the presence of oozing or encapsulated abscess. (iii) ultrasound or CT imaging or re-surgical confirmation of the presence of intra-abdominal ex |
Countries
China
Contacts
Primary ContactFu XU FUXU
Outcome results
None listed