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

Sponsor
B.P. Koirala Institute of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04994184
Collaborator
(none)
74
1
3.2
23

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    74 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Scoring System in Predicting Perforated Duodenal Ulcer Morbidity and Mortality in Bpkihs
    Actual Study Start Date :
    Mar 25, 2021
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Perforated duodenal ulcer

    MORBIDITY AND MORTALITY

    Outcome Measures

    Primary Outcome Measures

    1. Post PDU repair 30 day morbidity [30 day]

    2. Post PDU repair 30 day mortality [30 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nirmal Prasad sah Dharān Bāzār Province 1 Nepal

    Sponsors and Collaborators

    • B.P. Koirala Institute of Health Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nirmal Prasad Sah, Assistant Professor, B.P. Koirala Institute of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04994184
    Other Study ID Numbers:
    • 2095/020
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nirmal Prasad Sah, Assistant Professor, B.P. Koirala Institute of Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2021