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

Perforated Duodenal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994184
• Other study ID #: 2095/020
• Status: Completed
• Start date: March 25, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Duodenal Ulcer
• Perforated Duodenal Ulcer
• Ulcer

Locations

Country	Name	City	State
Nepal	Nirmal Prasad sah	Dharan Bazar	Province 1

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

References & Publications (6)

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. — View Citation

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

Mäkelä 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. — View Citation

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

Outcome

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