NCT05208489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

December 28, 2021

Last Update Submit

January 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative outcomes

    intra abdominal infections and other complications

    through out the hospitalization and 30 days after discharge.

Secondary Outcomes (1)

  • length of hospital stay

    post procedure to 30 days after discharge.

Interventions

there is no intervention involved in this study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients \<18 years are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20421025BACKGROUND
  • 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.

MeSH Terms

Conditions

Intestinal PerforationIntestinal ObstructionAbdominal Injuries

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesWounds and Injuries

Study Officials

  • Kartik Prabhakaran, MD

    New York Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trauma Medical Director

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 26, 2022

Study Start

December 16, 2021

Primary Completion

June 30, 2022

Study Completion

June 1, 2023

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations