NCT02879292

Brief Summary

Infantile hypertrophic pyloric stenosis (HPS) is one of the most common gastrointestinal medical emergencies.This retrospective study will review the files of all infants with HPS, who were treated by open pyloromyotomy under spinal anesthesia in the Bnai Zion Medical Center between the years 2006 to 2015.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

August 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 18, 2016

Last Update Submit

August 24, 2016

Conditions

Postoperative Pain

Keywords

Pyloric stenosis spinal anesthesia postoperative pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain measure in numerical scale

    till 24 hours after surgery

Secondary Outcomes (1)

  • Vomiting measure in numbers

    till 24 hours after surgery

Interventions

Spinal anesthesiaOTHER

Spinal Anesthesia

Eligibility Criteria

Age4 Weeks - 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All infants with Hypertrophic Pylorostenosis, who were treated by open pyloromyotomy under Spinal Anesthesia in the Bnai-Zion Medical Center between the years 2006 to 2015.

You may qualify if:

  • Infants with Hypertrophic Pylorostenosis, treated by open pyloromyotomy under Spinal Anesthesia

You may not qualify if:

  • Infants with Hypertrophic Pylorostenosis,treated by open pyloromyotomy under General Anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • mira koch, M.A.

    Bnai Zion Medical Center

    STUDY CHAIR

Central Study Contacts

Luis A Gaitini, M.D.

CONTACT

# 972 4 8359346luis.gaitini@b-zion.org.il

Mostafa Somri, M.D.

CONTACT

# 972 4 8359304mostafa.somri@b-zion.org.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 25, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share