Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Description

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.

Conditions

Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm

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Study Overview

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Study Details

Study overview

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.

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Condition
Cyst of Pancreas
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Patients \< 18 years old
  • * Patients who are pregnant
  • * Patients with a history of previous pancreatic surgery
  • * Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy
  • * Patients with prior cystogastrostomy procedure
  • * Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture
  • * Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively
  • * Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder
  • * Patients who undergo oversewing of the pancreatic transection margin
  • * Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain
  • * Patients who are unable to provide informed consent

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

Robert Simon, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Record Dates

2027-07-31