This is a prospective observational study of 526 infants who underwent laparoscopic pyloromyotomy. During surgery, their inguinal canals were examined for the presence of a patent processus vaginalis (PPV); they were then followed annually to determine the incidence and timing of any subsequent inguinal hernia development and need for repair. This study showed that while there was a high incidence of PPV during surgery, the need for inguinal hernia repair is low.
Summary:
Inguinal hernias are common in both men and women, with indirect inguinal hernias being the most frequently encountered type. These hernias are believed to arise due to a persistent patent processus vaginalist (PPV). However, there is a lack of literature regarding the natural progression of PPVs in the absence of symptomatic hernias. This knowledge gap results in inconclusive guidelines for managing incidentally discovered PPVs or those found on the contralateral side during inguinal hernia repair in children.
This prospective observational study included 526 infants under 4 months across 9 centers from the Midwest Pediatric Surgery Consortium. Patients who underwent laparoscopic pyloromyotomy were evaluated for the presence of a PPV in their bilateral inguinal canals. If a PPV was noted, further detail of location, size, estimated depth, and presence of scrotal/labial insufflation was recorded.
During initial surgery, there were a total of 283 (53.8%) PPVs identified, of which 132 (47%) were bilateral, 116 (41%) were only right sided, and 35 (12%) were only left sided. Patients with a PPV were significantly younger (1.1 months vs 1.3 months, p=0.02), weighed less (3.76 kg vs 3.9 kg, p=0.03), were more commonly male (88% vs 75%, p<0.001), and had a lower gestational age (38 weeks vs 39 weeks (p=0.003).
This study is ongoing with the intention to follow patients annually until 18 years old. At the time of interim analysis, 246 patients had reached at least one year of study enrollment. At 1-year follow up, 130/219 (59%) patients responded, with 3 reporting development of an inguinal hernia, all of which were managed operatively. At 2-year follow up, 64/151 (42%) responded, with no inguinal hernias reported. At 3-year follow up, 36/77 (47%) responded with no inguinal hernias reported. 22 patients have reached the 4-year follow up milestone so far, of which 16 (73%) had no reports of inguinal hernias.
The overall rate of inguinal hernias in the 246 PPVs discovered by the time of interim analysis was 1.2% (3/246), all of which, interestingly, occurred within the first 120 days after laparoscopic pyloromyotomy. This demonstrates that while the incidence of PPV during the first 4 months of life is high, the risk of developing a hernia or requiring repair is low. Some limitations of this study include the recruitment of a cohort of patients after detection of PPV during another surgery (retrospective), which means the reported incidence of PPV is likely artificially inflated. Additionally, similar studies have shown that patients ultimately needing hernia repair were in their teens, suggesting that the relatively short-term interim analysis of only 4 years is not yet long enough to capture the full range of pathology. Long-term follow-up of this cohort will further establish the subsequent natural history of development of inguinal hernia in infants born with a PPV.
Bottom line: This observational study showed that while patent processus vaginalis may be prevalent among infants, most will never become clinically relevant or require intervention.