Intestinal PerforationNCT05208489
Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes
An observational study of Intestinal Perforation and Intestinal Obstruction, run by New York Medical College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Perforation, Intestinal Obstruction, Trauma Abdomen
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2021to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients <18 years are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Medical College
Valhalla, New York, 10595
Anuritha Tirumani, 914-493-3470, anuritha.tirumani@wmchealth.org
Abbas Smiley, MD, 914-493-3470, abbas.smiley@wmchealth.org
About this study
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.
- Being tested
- there is no intervention involved in this study
- Medical subject headings
- Intestinal Perforation, Intestinal Obstruction, Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no intervention involved in this studyOther
there is no intervention involved in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative outcomes
intra abdominal infections and other complications
Measured: through out the hospitalization and 30 days after discharge.
Secondary outcomes (1)
length of hospital stay
includes ICU stay, ventilator days and mortality.
Measured: post procedure to 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start16 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kartik Prabhakaran, New York Medical College
- Investigators
- Kartik Prabhakaran, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208489
- Sponsor's protocol ID
- 14677
- Status last verified
- Jan 2022
- First submitted
- 28 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan as of now
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 20421025Zakaria 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 14599604Crafts 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Peritoneal Resuscitation for Intra-abdominal Catastrophes
- ClinicalTrials.gov ID
- NCT05208489
- Acronym / sponsor ID
- 14677
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients <18 years are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no intervention involved in this studythere is no intervention involved in this study. | Other | – |
Primary outcome
Post operative outcomes
Time frame: through out the hospitalization and 30 days after discharge.
intra abdominal infections and other complications
1 secondary outcome
length of hospital stay
Time frame: post procedure to 30 days after discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Background: PubMed 20421025Smith 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.
- Results publication: PubMed 14599604Zakaria 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.
- Results publication: PubMed 26169030Crafts 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.
- Individual participant dataSharing planned: Undecided. no plan as of now
Related trials for Intestinal Perforation
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingObservational study
Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip
GI Bleeding, Perforation Colon
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kartik Prabhakaran, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Perforation and Intestinal Obstruction, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anuritha Tirumani, MBBS (914-493-3470, anuritha.tirumani@wmchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative outcomes (time frame: through out the hospitalization and 30 days after discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208489, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.