Clinical trial NCT04994184: Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs
Official title: Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perforated Duodenal Ulcer
Keywords: PULP
Boey
ASA
Perforated duodenal ulcer
Risk score
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perforated duodenal ulcer patient who were managed surgically

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post PDU repair 30 day morbidity
timeFrame: 30 day
measure: Post PDU repair 30 day mortality
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: Nirmal Prasad sah
state: Province 1
Study officials:
References:
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citation: Moller 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.
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 study. Ann Med Surg (Lond). 2019 May 10;42:23-28. doi: 10.1016/j.amsu.2019.05.001. eCollection 2019 Jun.
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citation: Kim 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.