Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)
• Age ≥18 years
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Locations
United States
Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Robert Simon, MD
TaussigResearch@ccf.org
1-866-223-8100
Time Frame
Start Date: 2023-04-13
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 234
Treatments
Active_comparator: Standard of care
Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.
No_intervention: Omitting Standard of Care
No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center