Perforated Duodenal Ulcer Clinical Trial
Official title:
Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs
NCT number | NCT04994184 |
Other study ID # | 2095/020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 25, 2021 |
Est. completion date | July 1, 2021 |
Verified date | August 2021 |
Source | B.P. Koirala Institute of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | July 1, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 80 Years |
Eligibility | Inclusion Criteria: - All patient with perforated duodenal ulcer managed surgically Exclusion Criteria: - Perforated other organs eg: gastric ulcer or intestinal perforation Incomplete data available in database |
Country | Name | City | State |
---|---|---|---|
Nepal | Nirmal Prasad sah | Dharan Bazar | Province 1 |
Lead Sponsor | Collaborator |
---|---|
B.P. Koirala Institute of Health Sciences |
Nepal,
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Lohsiriwat 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: 10.1 — View Citation
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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. — View Citation
Møller 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 — View Citation
Saafan 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 stud — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post PDU repair 30 day morbidity | 30 day | ||
Primary | Post PDU repair 30 day mortality | 30 day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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