Page 29 - Effects and Efficacy of (Laparoscopic) Gastrostomy Placement in Children - Josephine Franken
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Chapter 2
Table 2 Risk of bias summary
study (year)
Prospective design
Randomized
standardization (study protocol)
Adequate report on loss-to- follow-up
Potential other sources of bias
Akay et al. 2010
-
-
-
NA
a, b
Conlon et al. 2004
-
-
-
NA
NR
Fraser et al. 2009
-
-
-
NA
NR
Zamakhshary et al. 2005
-
-
-
NA
c, d
Lee et al. 2002
-
-
-
NA
e
Legend: NR = Not Recorded; NA = Not Applicable (No lost to follow-up).
Standardization: Is the study conducted according to a predefined study protocol?
Loss-to-follow-up: Is there a complete report on loss-to-follow-up?
Potential other bias: a = Gastrostomy with antireflux procedure were excluded; b = Significant difference in age between groups; c = Undefined criteria for patient selection; d = Time horizon determines intervention and e = Only 8 without fundoplication in a total group of 51 patients
Primary outcomes
Only two studies reported on the success rates of the procedure. 16,17 The completion rates reported by Zamakhshary et al. 17 were similar for both groups (98% for PEG vs. 100% for LGP). Akay et al. 16 reported on the rate of conversion, which was also similar for both PEG (3.5%) and LGP (4.8%).
Only one study reported data comparing time to enteral feeding. 16 Time to reach first feeding (0.7 vs. 0.8 days) and time to reach full feedings (2.1 vs. 2.3 days) were similar for both PEG and LGP.
None of the studies reported data on the efficacy of enteral feeding, nutritional outcomes or QoL after both procedures.
None of the studies reported on GER symptoms or objective GER measurements. Only one study reported that 17 out of 234 patients (7.3%) who received a gastrostomy required an antireflux procedure to treat severe reflux symptoms. This study did not identify a statistically significant difference between PEG and LGP (p = 0.425). 16
Complications were addressed by all five studies. Three studies reported on adjacent bowel injury. 16,17,27 The risk of damaging adjacent intestine was significantly higher during PEG than during LGP (RR = 5.55, p = 0.047); Figure 2. There was no adjacent bowel injury in the LGP group. In the PEG group, 2 small bowel perforations and 7 colonic perforations occurred. In one patient, an iatrogenic perforation of the colon was made, and this was identified during the procedure. Consequently, PEG was converted to laparotomy to suture
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