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Laparoscopic pyloromyotomy (LPM) vs open pyloromyotomy (OPM) for hypertrophic pyloric stenosis: Is there a difference in the postoperative reconvalescence and the immunological response?

Laparoscopic pyloromyotomy (LPM) vs open pyloromyotomy (OPM) for hypertrophic pyloric stenosis: Is there a difference in the postoperative reconvalescence and the immunological response? - POEH-trial(PyloromyotomyOpenvsEndoscopic in Hypertrophic pyloric stenosis)

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31775
Enrollment
110
Registered
2009-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric obstruction hypertrophic pyloric stenosis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: All children who present with hypertrophic pyloric stenosis will be included in the study

Exclusion criteria

Exclusion criteria: All children with associated diseases or malformations which may influence the assessed parameters will be excluded, as will patients who are not able to have oral feedings due to other pathology than hypertrophic pyloric stenosis.

Design outcomes

Primary

MeasureTime frame
Clinical parameters, 5-9 are seen as complications. 1. Time to full feeding= time from operation and the second full feeding that is tolerated(38) -This is done by the attending nurse to prevent bias by the surgeon. 2. Postoperative use of analgesics, defined as amount of dosage given during postoperative stay 3. Period of admission, after surgery defined in hours. 4. Duration of surgery, defined in minutes. 5. Perforations 6. Woundinfections of the skin: defined as redness of the skin with presence of a purulent discharge with or without a positive microbiological culture. 7. Dehiscence of the fascia 8. Delay in time to full feeding= any set back in feeding due to vomiting. 9. Incomplete pyloromyotomy (defined as: need for re-operation) 10. Scars are followed in time and conventional digital photographs are made direct postoperative, after 3 weeks and 6 months.

Secondary

MeasureTime frame
Immunological parameters. Parameters of the immune system include serum CRP, IL-1RA, IL-6. These parameters are measured before introduction of anaesthesia and 6, 24 and 48 hrs after surgery. IL-1RA and IL-6 are determined during operation every 15 minutes and just before skin incision.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)