Perforated Duodenal UlcerNCT04994184
Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs
An observational study of Perforated Duodenal Ulcer, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
Different scoring systems were developed for risk prediction and adjustment of morbidity from perforated duodenal ulcer. However, these scoring systems are not routinely used in perforated duodenal ulcer patient in everyday clinical practice. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Perforated Duodenal Ulcer
- How many people
- 74 participants
- Where
- 1 siteNepal
- Study dates
- 25 Mar 2021to 1 Jul 2021
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Perforated duodenal ulcer patient who were managed surgically
Who may be able to join
- All patient with perforated duodenal ulcer managed surgically
Who cannot join
- Perforated other organs eg: gastric ulcer or intestinal perforation Incomplete data available in database
Trial locations and contacts
1 site in 1 country.
About this study
Different scoring systems were developed for risk prediction and adjustment of morbidity from perforated duodenal ulcer. However, these scoring systems are not routinely used in perforated duodenal ulcer patient in everyday clinical practice. Identification of patient with a high risk of adverse outcomes following surgery is important for clinical decision-making which can assist in risk stratification and triage e.g. timing and extent of pre-operative respiratory and circulatory stabilization, postoperative admission to a high dependency unit (HDU), the level and extent of monitoring, and inclusion in specific perioperative care protocols.
Few studies assessed and compared the accuracy indices of PULP with BOEY and ASA in predicting post PPU repair 30-day morbidity Further, the efficacy must be verified in individual settings like ours. So we wish to assess its efficacy in BPKIHS-a tertiary referral center of eastern Nepal.
Read the detailed description
Perforated peptic ulcer disease (PPU) is an important indication for emergency surgery, complicating 2%-10% of peptic ulcer disease. In the context of modern peptic ulcer therapy, the incidence of PPU has been declining over the past two decades, but mortality has not followed a commensurate decline, in spite of advances in operative strategy and perioperative care.
Omental patch repair of duodenal ulcer perforation is both simpler than and as effective as definitive ulcer surgery in the emergency situation.
However,mortality due to ulcer perforation treated by simple closure and/or other methods is still around 10%. Factors reported to affect mortality in duodenal ulcer perforations in other series are old age, co-morbidity, preoperative hypotension, large size of the perforation, delay in presentation, and, delay in operation .
Several scoring systems have been proposed for the predictions of 30-day morbidity and mortality of perforated peptic ulcer (PPU) in order to risk stratify patients subject to their anticipated complications, and accordingly direct the required attention to high-risk patients. Scoring systems most commonly used include ASA (American Society of Anesthesiologists), Boey and peptic ulcer perforation score (PULP). Each comprises 3-11 demographic, clinical and biochemical variables that consider only pre-operative, or include pre/intra -operative and laboratory findings. Clinical scoring systems need good diagnostic accuracy in order to risk stratify patients correctly.
- Conditions
- Perforated Duodenal Ulcer
- Keywords
- PULP, Boey, ASA, Perforated duodenal ulcer, Risk score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Perforated duodenal ulcer | MORBIDITY AND MORTALITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post PDU repair 30 day morbidity
Measured: 30 day
Post PDU repair 30 day mortality
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start25 Mar 2021
- Primary completion30 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perforated Duodenal UlcerStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirmal Prasad Sah, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994184
- Sponsor's protocol ID
- 2095/020
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Menekse E, Kocer B, Topcu R, Olmez A, Tez M, Kayaalp C. A practical scoring system to predict mortality in patients with perforated peptic ulcer. World J Emerg Surg. 2015 Feb 21;10:7. doi: 10.1186/s13017-015-0008-7. eCollection 2015.
PubMed 25722739Moller MH, Engebjerg MC, Adamsen S, Bendix J, Thomsen RW. The Peptic Ulcer Perforation (PULP) score: a predictor of mortality following peptic ulcer perforation. A cohort study. Acta Anaesthesiol Scand. 2012 May;56(5):655-62. doi: 10.1111/j.1399-6576.2011.02609.x. Epub 2011 Dec 23.
PubMed 22191386Saafan T, El Ansari W, Al-Yahri O, Eleter A, Eljohary H, Alfkey R, Hajjar M, Toffaha A, El Osta A. Assessment of PULP score in predicting 30-day perforated duodenal ulcer morbidity, and comparison of its performance with Boey and ASA, a retrospective study. Ann Med Surg (Lond). 2019 May 10;42:23-28. doi: 10.1016/j.amsu.2019.05.001. eCollection 2019 Jun.
PubMed 31193430Lohsiriwat V, Prapasrivorakul S, Lohsiriwat D. Perforated peptic ulcer: clinical presentation, surgical outcomes, and the accuracy of the Boey scoring system in predicting postoperative morbidity and mortality. World J Surg. 2009 Jan;33(1):80-5. doi: 10.1007/s00268-008-9796-1.
PubMed 18958520Makela JT, Kiviniemi H, Ohtonen P, Laitinen SO. Factors that predict morbidity and mortality in patients with perforated peptic ulcers. Eur J Surg. 2002;168(8-9):446-51. doi: 10.1080/110241502321116424.
PubMed 12549682Kim JM, Jeong SH, Lee YJ, Park ST, Choi SK, Hong SC, Jung EJ, Ju YT, Jeong CY, Ha WS. Analysis of risk factors for postoperative morbidity in perforated peptic ulcer. J Gastric Cancer. 2012 Mar;12(1):26-35. doi: 10.5230/jgc.2012.12.1.26. Epub 2012 Mar 30.
PubMed 22500261
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs
- ClinicalTrials.gov ID
- NCT04994184
- Acronym / sponsor ID
- 2095/020
- Conditions
- Perforated Duodenal Ulcer
- Keywords
- PULP, Boey, ASA, Perforated duodenal ulcer, Risk score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 6 Aug 2021 (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.
Different scoring systems were developed for risk prediction and adjustment of morbidity from perforated duodenal ulcer. However, these scoring systems are not routinely used in perforated duodenal ulcer patient in everyday clinical practice. Identification of patient with a high risk of adverse outcomes following surgery is important for clinical decision-making which can assist in risk stratification and triage e.g. timing and extent of pre-operative respiratory and circulatory stabilization, postoperative admission to a high dependency unit (HDU), the level and extent of monitoring, and inclusion in specific perioperative care protocols.
Few studies assessed and compared the accuracy indices of PULP with BOEY and ASA in predicting post PPU repair 30-day morbidity Further, the efficacy must be verified in individual settings like ours. So we wish to assess its efficacy in BPKIHS-a tertiary referral center of eastern Nepal.
Detailed description
Perforated peptic ulcer disease (PPU) is an important indication for emergency surgery, complicating 2%-10% of peptic ulcer disease. In the context of modern peptic ulcer therapy, the incidence of PPU has been declining over the past two decades, but mortality has not followed a commensurate decline, in spite of advances in operative strategy and perioperative care.
Omental patch repair of duodenal ulcer perforation is both simpler than and as effective as definitive ulcer surgery in the emergency situation.
However,mortality due to ulcer perforation treated by simple closure and/or other methods is still around 10%. Factors reported to affect mortality in duodenal ulcer perforations in other series are old age, co-morbidity, preoperative hypotension, large size of the perforation, delay in presentation, and, delay in operation .
Several scoring systems have been proposed for the predictions of 30-day morbidity and mortality of perforated peptic ulcer (PPU) in order to risk stratify patients subject to their anticipated complications, and accordingly direct the required attention to high-risk patients. Scoring systems most commonly used include ASA (American Society of Anesthesiologists), Boey and peptic ulcer perforation score (PULP). Each comprises 3-11 demographic, clinical and biochemical variables that consider only pre-operative, or include pre/intra -operative and laboratory findings. Clinical scoring systems need good diagnostic accuracy in order to risk stratify patients correctly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perforated duodenal ulcer | – | –MORBIDITY AND MORTALITY |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Perforated duodenal ulcer patient who were managed surgically
Key inclusion criteria (1 listed)
- All patient with perforated duodenal ulcer managed surgically
Key exclusion criteria (1 listed)
- Perforated other organs eg: gastric ulcer or intestinal perforation Incomplete data available in database
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post PDU repair 30 day morbidity
Time frame: 30 day
Post PDU repair 30 day mortality
Time frame: 30 day
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 9 Aug 2021.
- Results publication: PubMed 25722739Menekse E, Kocer B, Topcu R, Olmez A, Tez M, Kayaalp C. A practical scoring system to predict mortality in patients with perforated peptic ulcer. World J Emerg Surg. 2015 Feb 21;10:7. doi: 10.1186/s13017-015-0008-7. eCollection 2015.
- Results publication: PubMed 22191386Moller MH, Engebjerg MC, Adamsen S, Bendix J, Thomsen RW. The Peptic Ulcer Perforation (PULP) score: a predictor of mortality following peptic ulcer perforation. A cohort study. Acta Anaesthesiol Scand. 2012 May;56(5):655-62. doi: 10.1111/j.1399-6576.2011.02609.x. Epub 2011 Dec 23.
- Results publication: PubMed 31193430Saafan T, El Ansari W, Al-Yahri O, Eleter A, Eljohary H, Alfkey R, Hajjar M, Toffaha A, El Osta A. Assessment of PULP score in predicting 30-day perforated duodenal ulcer morbidity, and comparison of its performance with Boey and ASA, a retrospective study. Ann Med Surg (Lond). 2019 May 10;42:23-28. doi: 10.1016/j.amsu.2019.05.001. eCollection 2019 Jun.
- Results publication: PubMed 18958520Lohsiriwat V, Prapasrivorakul S, Lohsiriwat D. Perforated peptic ulcer: clinical presentation, surgical outcomes, and the accuracy of the Boey scoring system in predicting postoperative morbidity and mortality. World J Surg. 2009 Jan;33(1):80-5. doi: 10.1007/s00268-008-9796-1.
- Results publication: PubMed 12549682Makela JT, Kiviniemi H, Ohtonen P, Laitinen SO. Factors that predict morbidity and mortality in patients with perforated peptic ulcers. Eur J Surg. 2002;168(8-9):446-51. doi: 10.1080/110241502321116424.
- Results publication: PubMed 22500261Kim JM, Jeong SH, Lee YJ, Park ST, Choi SK, Hong SC, Jung EJ, Ju YT, Jeong CY, Ha WS. Analysis of risk factors for postoperative morbidity in perforated peptic ulcer. J Gastric Cancer. 2012 Mar;12(1):26-35. doi: 10.5230/jgc.2012.12.1.26. Epub 2012 Mar 30.
- Individual participant dataSharing planned: No
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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.
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 Perforated Duodenal Ulcer, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 9 Aug 2021. 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 Nepal. 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?
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 PDU repair 30 day morbidity (time frame: 30 day). 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?
On the ClinicalTrials.gov record for NCT04994184, which also lists 6 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 9 Aug 2021.