An open, single center, single-arm phase II study to evaluate the safety of a modificated perioperative analgesia with Indometacin during pancreaticoduodenectomy
- Conditions
- MedDRA - 10045751 (Unspecified disease of pancreas)
- Registration Number
- DRKS00011321
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 58
1. Age >=18 years
2. Indication for pancreatoduodenectomy
3. Signed informed consent
1. Perioperative application of platelet aggregation inhibitors
2. Application of other NSARs
3. Application of selective serotonin reuptake inhibitors, Triamteren oder Diflunisal
4. Preexisting ischemic heart disease
5. Preexisting peripheral arterial disease
6. Preexisting cerebrovascular disease
7. Morbus Crohn
8. Colitis ulcerosa
9. Pregnancy and breast-feeding
10. Persons of child-bearing potential not willing or able to use safe methods of contraception
11. Preexisting allergies on other substances, pollen or allergic asthma
12. Limited legal competence
13. Participation in another intervential trial that could interfere with the treatment or outcome of this study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severe postoperative complications (>= grade IV according to the Clavien-Dindo-classification) until 6 weeks after pancreatoduodenectomy with application of Indometacin
- Secondary Outcome Measures
Name Time Method 1.) Surgical quality characteristic: <br>Mortality, <br>bleeding according to ISGPF grade a, b, c; Delayed gastric emptying according to ISGPF grade a, b, c; <br>Pancreatic fistula according to ISGPF grade a, b, c; <br>Rate of reoperations; <br>Need of salvage pancreatectomy; <br>Abcessus with need of therapy.<br>2.) Non-surgical comlications:<br>Septic shock<br>respiratory failure<br>deep vein thrombosis<br>pulmonary embolism<br>Myocardial infaction<br>stroke<br>3.) Perioperative quality characteristics:<br>Operation time (incision-suture)<br>Days on ICU<br>Readmission on ICU<br>Days of hospitalization<br>4.) Safety:<br>AEs<br>SAEs