Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs

Completed

• Conditions: Perforated Duodenal Ulcer

• Registration Number: NCT04994184
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

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.

Study Timeline

• Study Start: 2021-03-25
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-01
• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-07-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• All patient with perforated duodenal ulcer managed surgically

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Exclusion Criteria

• Perforated other organs eg: gastric ulcer or intestinal perforation Incomplete data available in database

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post PDU repair 30 day morbidity	30 day
Post PDU repair 30 day mortality	30 day

Trial Locations

Locations (1)

Nirmal Prasad sah; 🇳🇵 Dharān Bāzār, Province 1, Nepal