NCT04994184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

July 29, 2021

Last Update Submit

August 5, 2021

Conditions

Keywords

PULPBoeyASAPerforated duodenal ulcerRisk score

Outcome Measures

Primary Outcomes (2)

  • Post PDU repair 30 day morbidity

    30 day

  • Post PDU repair 30 day mortality

    30 day

Study Arms (1)

Perforated duodenal ulcer

MORBIDITY AND MORTALITY

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Perforated duodenal ulcer patient who were managed surgically

You may qualify if:

  • All patient with perforated duodenal ulcer managed surgically

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nirmal Prasad sah

Dharān, Koshi, Nepal

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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: 10.1007/s00268-008-9796-1.

  • Makela 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. doi: 10.1080/110241502321116424.

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 6, 2021

Study Start

March 25, 2021

Primary Completion

June 30, 2021

Study Completion

July 1, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations