Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative ComplicationsPERIMOPPNCT07047911
Predictors of Morbidity in Perforation Peritonitis: A Prospective Observational Study From a Tertiary Care Centre in North India
An observational study of Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications, run by Government Medical College, Patiala.
Trial summary
This is a prospective observational cohort study conducted at a tertiary care hospital in North India. The study aims to evaluate clinical and biochemical predictors of postoperative morbidity in patients undergoing emergency laparotomy for gastrointestinal perforation peritonitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications
- What is being tested?
- Observational only - surgical management not assigned by study
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2014to 10 May 2016
- 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: A total of 50 adult patients were enrolled prospectively over a 2-year period at Government Medical College \& Rajindra Hospital, Patiala.
Who may be able to join
- Adults (>18 years) with gastrointestinal perforation-induced peritonitis
Who cannot join
- Primary peritonitis, anastomotic leaks, refusal of surgery, or patients discharged against medical advice
About this study
This is a prospective observational cohort study conducted at a tertiary care hospital in North India. The study aims to evaluate clinical and biochemical predictors of postoperative morbidity in patients undergoing emergency laparotomy for gastrointestinal perforation peritonitis. Data on patient demographics, comorbidities, surgical timing, renal function, and complications were collected and analyzed to identify factors associated with increased morbidity. The findings are expected to support early risk stratification and improved clinical management of surgical emergencies.
- Being tested
- Observational only - surgical management not assigned by study
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational only - surgical management not assigned by studyOther
Observational only - surgical management not assigned by study
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative morbidity
Measured: 30days
Post operative morbidity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start10 Mar 2014
- Primary completion1 Mar 2016
- Study completion10 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative ComplicationsStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Patiala
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lakshay Singla, Government Medical College, Patiala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047911
- Sponsor's protocol ID
- GMC-PERITONITIS-2016
- Acronym
- PERIMOPP
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Morbidity in Perforation Peritonitis: A Prospective Observational Study From a Tertiary Care Centre in North India
- ClinicalTrials.gov ID
- NCT07047911
- Acronym / sponsor ID
- PERIMOPP / GMC-PERITONITIS-2016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Government Medical College, PatialaOther government
- Study start
- 10 Mar 2014 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 10 May 2016 (actual)
- First posted
- 2 Jul 2025 (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.
This is a prospective observational cohort study conducted at a tertiary care hospital in North India. The study aims to evaluate clinical and biochemical predictors of postoperative morbidity in patients undergoing emergency laparotomy for gastrointestinal perforation peritonitis. Data on patient demographics, comorbidities, surgical timing, renal function, and complications were collected and analyzed to identify factors associated with increased morbidity. The findings are expected to support early risk stratification and improved clinical management of surgical emergencies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 adult patients were enrolled prospectively over a 2-year period at Government Medical College \& Rajindra Hospital, Patiala.
Key inclusion criteria (1 listed)
- Adults (>18 years) with gastrointestinal perforation-induced peritonitis
Key exclusion criteria (1 listed)
- Primary peritonitis, anastomotic leaks, refusal of surgery, or patients discharged against medical advice
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 |
|---|---|---|
| Observational only - surgical management not assigned by studyObservational only - surgical management not assigned by study | Other | – |
Primary outcome
Post operative morbidity
Time frame: 30days
Post operative morbidity
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications, run by Government Medical College, Patiala.
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 1 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: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative morbidity (time frame: 30days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2025.