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.
Pancreatic resections are commonly performed across the United States, yet still represent one of the most morbid abdominal operations in the country, with postoperative mortality as high as 7.7%. Distal pancreatectomy (DP) represents one of the most common approaches to pancreatic resection and is typically used for tumors of the pancreatic body or tail. This operation is known to have a high historic morbidity, with reports of overall morbidity between 12-52%. Common complications include intraabdominal abscess and surgical site infection. Postoperative pancreatic fistula (POPF) represents the most common complication following partial pancreatic resection, with rates reported with rates as high as 30% in multiple large retrospective studies. Multiple strategies to prevent postoperative pancreatic leak following distal pancreatectomy have been studied. One of the outstanding questions that remains is regarding the need for routine intraperitoneal drainage following DP, particularly since the advent of reinforced staple technology. This study aims to determine if intraperitoneal drainage is necessary following DP. This study will compare groups using a composite endpoint of complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
234
19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGComposite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF
Time frame: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Grade C POPF
Time frame: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes Readmission
Time frame: Within 90 days of surgery
Composite endpoint comparison
Comparison between groups using a composite endpoint of complications that includes presence of Organ Space Surgical Site Infection
Time frame: Within 90 days of surgery
Rates of endoscopic drainage vs percutaneous drainage of Grade B POPF
Rates of drainage based off of the Grade B Postoperative pancreatic fistula
Time frame: 90-day post operative time point
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Global Health
Time frame: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Physical Function
Time frame: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the original Drain Quality of Life scale
Time frame: At day 14 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Global Health
Time frame: At day 90 postoperative
Quality of Life Score
Post-operative Quality of Life score using the PROMIS-10 Physical Function
Time frame: At day 90 postoperative
Quality of Life Score
Post-operative Quality of Life score using the original Drain Quality of Life scale
Time frame: At day 90 postoperative
Hospital Length of Stay
Measurement of the difference in Hospital Length-of-Stay based on intraperitoneal drainage after DP
Time frame: 90-day post operative time point
Cost analysis for overall healthcare costs
Cost analysis for overall healthcare costs associated with both methods of postoperative care
Time frame: At day 90 postoperative
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