The aim of this study is to compare LPM with OPM with respect to clinical benefits or disadvantages of LPM in children with hypertrophic pyloric stenosis.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
LPM, as compared with OPM, is better because it results in less complications,
has a superior cosmetic outcome is possible less traumatic in clinical (faster
recovery) and immunological outcome.
Laparoscopische pyloromyotomie (LP) is, in vergelijking met open pyloromyotomie
beter omdat het minder postoperatieve complicaties heeft, tevens een superieur
cosmetisch resultaat en is mogelijk minder traumatisch zowel qua
kliniek(sneller herstel) als immunologisch.
Study objective
The aim of this study is to compare LPM with OPM with respect to clinical
benefits or disadvantages of LPM in children with hypertrophic pyloric
stenosis.
Study design
The study will be performed at the Pediatric Surgical Center of Amsterdam
(PSCA), at the AMC and VUmc. All children who present with hypertrophic pyloric
stenosis will be included in the study. They will be treated and assessed
strictly according to the described protocol.
Operations are performed by paediatric surgeons after completion of their
learning curves. All (both the laparoscopic and the open) operations are
considered as index-operations and are performed by staff-members and fellows
of the PSCA.
Scoring and registration of postoperative performed reconvalescence and
complaints will be performed by nurses who are not aware of the operative
technique used.
Study burden and risks
Bloodsamples will be taken depending on postoperative stay in an amount of 5 to
6 cc/patient/duration of stay.
Meibergdreef 9
1105 AZ
Nederland
Meibergdreef 9
1105 AZ
Nederland
Listed location countries
Age
Inclusion criteria
All children who present with hypertrophic pyloric stenosis will be included in the study
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16253.018.07 |