PREPARE - Intrapapillary botulinum toxin injection for PREvention of post-surgical PAncREatic fistula

Conditions

PANCREATIC FISTULA

Brief summary

Clinically relevant POPF (grade B and C) in the 3 months after DP.

Detailed description

Grade of postoperative pancreatic fistulas (B, C) based on the ISGPF 2016 update, Biochemical leak after surgery, Postoperative complications: intra-abdominal fluid collection, delayed gastric emptying, hemorrhage, pancreatitis, wound infection, other infectious complication, Clavien-Dindo classification for post-surgical morbidity, Health economics endpoints: duration of hospital stay, hospital readmissions, transfer to intensive care unit and the duration of these stays, fistularelated postoperative invasive procedures, overall costs, the incremental cost utility ratio, the incremental cost effectiveness ratio based upon the clinical endpoint of mortality and post-surgical complication including pancreatic fistula, Quality of life score (EQ5D5L questionnaire), Postsurgical mortality (30 and 90-day), Side effects related to the endoscopic botulinum toxin injection

Related papers

No related papers found yet.

Interventions

DRUGXEOMIN 100 unités

DRUGpoudre pour solution injectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Clinically relevant POPF (grade B and C) in the 3 months after DP.	—

Secondary

Measure	Time frame
Grade of postoperative pancreatic fistulas (B, C) based on the ISGPF 2016 update, Biochemical leak after surgery, Postoperative complications: intra-abdominal fluid collection, delayed gastric emptying, hemorrhage, pancreatitis, wound infection, other infectious complication, Clavien-Dindo classification for post-surgical morbidity, Health economics endpoints: duration of hospital stay, hospital readmissions, transfer to intensive care unit and the duration of these stays, fistularelated postoperative invasive procedures, overall costs, the incremental cost utility ratio, the incremental cost effectiveness ratio based upon the clinical endpoint of mortality and post-surgical complication including pancreatic fistula, Quality of life score (EQ5D5L questionnaire), Postsurgical mortality (30 and 90-day), Side effects related to the endoscopic botulinum toxin injection	—

Measure

Time frame

Grade of postoperative pancreatic fistulas (B, C) based on the ISGPF 2016 update, Biochemical leak after surgery, Postoperative complications: intra-abdominal fluid collection, delayed gastric emptying, hemorrhage, pancreatitis, wound infection, other infectious complication, Clavien-Dindo classification for post-surgical morbidity, Health economics endpoints: duration of hospital stay, hospital readmissions, transfer to intensive care unit and the duration of these stays, fistularelated postoperative invasive procedures, overall costs, the incremental cost utility ratio, the incremental cost effectiveness ratio based upon the clinical endpoint of mortality and post-surgical complication including pancreatic fistula, Quality of life score (EQ5D5L questionnaire), Postsurgical mortality (30 and 90-day), Side effects related to the endoscopic botulinum toxin injection

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Countries

France

Outcome results

None listed