ClinicalTrials.gg
Status unknownNCT05208489Updated Jan 26, 2022

Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes

An observational study in Intestinal Perforation, Intestinal Obstruction and Trauma Abdomen, sponsored by New York Medical College. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by New York Medical College · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
108
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intestinal Perforation
  • Intestinal Obstruction
  • Trauma Abdomen
03

In context

Intestinal Perforation

36 studies on the registry are indexed under Intestinal Perforation; 5 are open to participants now.

This study's planned enrollment of 108 is below the median of 203 across 20 observational studies indexed under Intestinal Perforation.

Browse Intestinal Perforation studies →

Lead sponsor

New York Medical College is the lead sponsor of 71 studies on the registry; 24 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients \<18 years are excluded.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
108 participants (estimated)
Patient registry
No

Interventions

  • Otherthere is no intervention involved in this study

    there is no intervention involved in this study.

06

What researchers measure

Primary outcomes

  1. Post operative outcomes

    intra abdominal infections and other complications

    Time frame: through out the hospitalization and 30 days after discharge.

Secondary outcomes

  1. length of hospital stay

    includes ICU stay, ventilator days and mortality.

    Time frame: post procedure to 30 days after discharge.

07

Study locations

1 of 1 sites recruiting
  • New York Medical College
    Valhalla, New York 10595, United States
    Recruiting
08

References and documents

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. PubMed 20421025 ↗
  • 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. PubMed 14599604 ↗
  • 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. PubMed 26169030 ↗

Individual participant data

Plan to share: Undecided — no plan as of now

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2021 (actual). Primary completion is estimated for Jun 2022, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2021
First posted
Jan 26, 2022
StartActual
Dec 16, 2021
Primary completionEst.
Jun 30, 2022
CompletionEst.
Jun 2023
Last update
Jan 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05208489
Lead sponsor
New York Medical College
Responsible party
Kartik Prabhakaran (Trauma Medical Director, New York Medical College) — Principal investigator
First posted
Jan 26, 2022
Start date
Dec 16, 2021
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 2023 (estimated)
Last update
Jan 26, 2022

Study contacts

Anuritha Tirumani, MBBS
Contact
anuritha.tirumani@wmchealth.org
914-493-3470
Abbas Smiley, MD
Contact
abbas.smiley@wmchealth.org
914-493-3470
Kartik Prabhakaran, MD
principal investigator · New York Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion