Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes

It is a retrospective study. Patients, who presented with either traumatic or general surgery emergencies, undergone exploratory laparotomy, had an open abdomen management and received Direct Peritoneal Resuscitation in addition to standard resuscitation will be considered as meeting the criteria to collect the data.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Obstruction; Trauma Abdomen; Intestinal Perforation
• Intervention / Treatment: Other: there is no intervention involved in this study

Detailed Description

Due to the high volume of patient transfers from different facilities with difficult intra-abdominal pathologies and the high case-mix index at Westchester Medical Center, we see many patients who require re-operations and open abdominal management. Since July1st of 2020 we have been using DPR in addition to standard iv fluids on all patients who undergo open abdominal management and it is now standard of care at our facility. we plan to collect the data from all qualified subjects who received DRP since 7/1/2020 to 6/30/2022.

• Study Type: Observational
• Enrollment (Anticipated): 108

Contacts and Locations

• Study Contact: Name: Anuritha Tirumani, MBBS; Phone Number: 914-493-3470; Email: anuritha.tirumani@wmchealth.org
• Study Contact Backup: Name: Abbas Smiley, MD; Phone Number: 914-493-3470; Email: abbas.smiley@wmchealth.org

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • Recruiting
      • New York Medical College
      • Contact: Abbas Smiley, MD; Phone Number: 914-493-3470; Email: abbas.smiley@wmchealth.org
      • Contact: Anuritha Tirumani; Phone Number: 914-493-3470; Email: anuritha.tirumani@wmchealth.org
      • Principal Investigator: Kartik Prabhakaran, MD
      • Sub-Investigator: Rifat Latifi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients 18 and above, who presents with either traumatic or general surgery emergencies and undergone exploratory laparotomy had an open abdomen management and received DPR in addition to standard resuscitation will be considered as meeting the criteria to be in the study.

Description

Inclusion Criteria:

• Adult patients 18 years of age or older.
• Trauma or General surgery patients who undergo emergency abdominal surgery via laparotomy and who had open abdominal management during the index procedure at our institution.
• Patients who are transferred to our institution with an already open abdomen will also be eligible if they required continued open abdominal management.

Exclusion Criteria:

• Patients <18 years are excluded.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative outcomes	intra abdominal infections and other complications	through out the hospitalization and 30 days after discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	includes ICU stay, ventilator days and mortality.	post procedure to 30 days after discharge.

Collaborators and Investigators

• Sponsor: New York Medical College
• Investigators: Principal Investigator: Kartik Prabhakaran, MD, New York Medical College

Publications and helpful links

General Publications

• Smith JW, Garrison RN, Matheson PJ, Franklin GA, Harbrecht BG, Richardson JD. Direct peritoneal resuscitation accelerates primary abdominal wall closure after damage control surgery. J Am Coll Surg. 2010 May;210(5):658-64, 664-7. doi: 10.1016/j.jamcollsurg.2010.01.014.
• Zakaria el R, Hurt RT, Matheson PJ, Garrison RN. A novel method of peritoneal resuscitation improves organ perfusion after hemorrhagic shock. Am J Surg. 2003 Nov;186(5):443-8. doi: 10.1016/j.amjsurg.2003.07.006.
• Crafts TD, Hunsberger EB, Jensen AR, Rescorla FJ, Yoder MC, Markel TA. Direct peritoneal resuscitation improves survival and decreases inflammation after intestinal ischemia and reperfusion injury. J Surg Res. 2015 Dec;199(2):428-34. doi: 10.1016/j.jss.2015.06.031. Epub 2015 Jun 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2021
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (ACTUAL): January 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Intestinal Perforation
• Other Study ID Numbers: 14677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: no plan as of now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No