Clinical trial NCT05208489: Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes
Official title: Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Perforation
Intestinal Obstruction
Trauma Abdomen
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post operative outcomes
timeFrame: through out the hospitalization and 30 days after discharge.
Secondary outcomes:
measure: length of hospital stay
timeFrame: post procedure to 30 days after discharge.
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Kartik Prabhakaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/j.amjsurg.2003.07.006.
citation: 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.