Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes

Intestinal Obstruction Clinical Trial

Official title:

Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208489
• Other study ID #: 14677
• Status: Recruiting
• Start date: December 16, 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2022
• Source: New York Medical College
• Contact: Anuritha Tirumani, MBBS
• Phone: 914-493-3470
• Email: anuritha.tirumani[@]wmchealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Obstruction
• Intestinal Perforation
• Trauma Abdomen

Intervention

Other:
• there is no intervention involved in this study
there is no intervention involved in this study.

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.20 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative outcomes	intra abdominal infections and other complications	through out the hospitalization and 30 days after discharge.
Secondary	length of hospital stay	includes ICU stay, ventilator days and mortality.	post procedure to 30 days after discharge.