Laparoscopic-assisted versus Open Placement of Ventriculoperitoneal Shunts in the Pediatric Population with Congenital Hydrocephalus: A Randomized Controlled Trial

ABSTRACT

Background:

Ventriculoperitoneal (VP) shunt is the standard surgical treatment for hydrocephalus. Conventional open insertion of the distal catheter is widely practiced; however, laparoscopic-assisted right VP shunt (LARVS) provides direct visualization of peritoneal entry, potentially reducing complications and improving accuracy.

Aim:

The aim of this study was to compare LARVS with conventional open right VP shunt (RVS) in terms of operative parameters, postoperative outcomes, and complication rates.

Materials and Methods:

A randomized controlled trial was conducted on 76 patients undergoing primary RVS between July 2020 and August 2024. The patients were divided into two groups: Group A – LARVS (n = 37) and Group B – RVS (n = 39). The data analyzed included age, operative time, duration of hospital stay, type of hydrocephalus, and postoperative complications. Statistical analysis was performed using the t-test and Chi-square tests; P < 0.05 was considered statistically significant.

Results:

The two groups were comparable in terms of baseline characteristics (age, P = 0.089). The mean operative time was 62.14 ± 8.9 min for LARVS and 64.97 ± 9.8 min for RVS (P = 0.296). The average hospital stay was 5.94 ± 1.1 days for LARVS and 5.55 ± 1.2 days for RVS (P = 0.797). Noncommunicating hydrocephalus predominated (LARVS: 89%; RVS: 87%). Overall complication rates were low and not significantly different (P = 0.300). Shunt revision was required in 8.1% (LARVS) and 7.7% (RVS), cerebrospinal fluid leak occurred in 2.6% of the RVS group and 2.7% in the LARVS group. No visceral injury or port-related morbidity occurred in the laparoscopic group.

Conclusion:

LARVS is a safe and effective alternative to open RVS. Both approaches yield comparable operative times and outcomes, with LARVS offering the added advantage of direct peritoneal visualization, although its impact on morbidity was not statistically different in this cohort.

Type of study: Clinical research.

Level of evidence: Level II.

INTRODUCTION

Hydrocephalus is a common pediatric condition that requires surgery. Ventriculoperitoneal (VP) shunting is a long-standing procedure for this disease with minor modifications. In principle VP shunt diverts cerebrospinal fluid (CSF) and thus lowers intracranial pressure and provides an alternate channel for CSF flow. First described in 1908, VP shunting is generally a safe procedure; however, the postoperative complications of VP shunting, including infection, obstruction, and catheter displacement, have remained common, with revision rates approaching 40% within the first 12 months.[1] The distal end of the catheter is particularly prone to complications owing to its dynamic position. Laparoscopy allows direct visualization of the peritoneal cavity, enabling accurate positioning of the catheter tip and confirmation of intraperitoneal placement. Several studies have demonstrated improved outcomes with this approach. For example, a large comparative series reported that distal shunt obstruction occurred significantly more often after open placement, with distal obstruction accounting for 35.7% of obstructions in the open group versus 4.8% in the laparoscopic group.[2]

Furthermore, a recent systematic review and meta-analysis found that laparoscopic peritoneal access was associated with a lower rate of distal shunt failure (2.2%) than open laparotomy (6.1%), along with shorter operative time and hospital stay.[3]

Lower-end placement was traditionally performed using an open laparotomy technique; however, we performed it laparoscopically and analyzed the differences in terms of operative time, results, and complications.

MATERIALS AND METHODS

Study design and setting

This study was designed as a prospective, double-arm, parallel-group randomized controlled trial conducted in the Department of Pediatric Surgery from July 2020 to August 2024. The trial compared laparoscopic-assisted right VP shunt (LARVS) placement with conventional open right ventriculoperitoneal shunt (RVS) placement in pediatric patients diagnosed with hydrocephalus.

Participants

A diagnosis of hydrocephalus (communicating or noncommunicating) was established based on clinical history, physical examination, cranial ultrasonography, and nonenhanced computed tomography of the brain. Eligible patients underwent primary placement of a VP shunt.

Inclusion criteria

• Diagnosed cases of hydrocephalus (communicating or noncommunicating)

• Primary VP shunt placement.

Exclusion criteria

• Previous abdominal surgery with suspected adhesions

• Shunt revisions

• Active shunt infection at presentation.

Parents or legal guardians were informed about the study procedures, and written informed consent was obtained prior to enrollment.

Randomization and allocation concealment

Participants were randomized in a 1:1 allocation ratio into two groups: LARVS (Group A) and RVS (Group B). Randomization was performed using block randomization with a block size of four. The allocation sequence was generated before patient recruitment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes. The envelopes were opened sequentially after patient enrollment to determine group assignment. A total of 38 patients were allocated to each group.

Blinding

Owing to the nature of surgical interventions, blinding of the operating surgeon and participants was not feasible. However, postoperative outcome assessment and statistical analysis were conducted without knowledge of group allocation, wherever applicable.

Interventions

In both the groups, the ventricular end of the shunt was placed using the standard technique.

In Group A (LARVS), the distal peritoneal end of the shunt was placed laparoscopically. The patient was positioned supine with a sandbag under the shoulders to align the head, neck, and abdomen. A 5-mm umbilical port was introduced using the open technique, and a 3-mm working port was placed in the midclavicular line at the level of the umbilicus [Figure 1a]. The abdomen was screened for the presence of inguinal hernias or any other obvious congenital malformations. After screening, the tip of the VP shunt was held with mosquito forceps, and the rectus was pierced to place the tip in the abdomen through the incision (<1 cm) made in the upper abdomen for tunneling. Once the tip was visualized inside the abdomen, the 3-mm Maryland forceps grasped the end and pulled it completely inside the abdomen and positioned it over the suprahepatic region [Figure 1b]. The peritoneal cavity was inspected for inguinal hernias or other congenital anomalies. Thus, the distal catheter was introduced through the anterior abdominal wall and placed intraperitoneally under direct visualization. Port closure was performed after confirming correct positioning. All three incisions were subcentimetric in size.

Figure 1.

(a) Port placement, (b) Intraperitoneal shunt showing cerebrospinal fluid flow. CSF: cerebrospinal fluid

In Group B (RVS), the distal catheter was placed using a conventional open approach through a right upper abdominal incision.

Follow-up and outcome measures

The baseline clinical parameters recorded included age (months), head circumference (cm), type of hydrocephalus, operative time (min), and integrity of the hernial orifices.

Patients were followed up postoperatively at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year to assess for complications, including CSF leak, shunt revision, wound-related complications, and other procedure-related adverse events.

Handling of protocol deviation

One participant randomized to the LARVS group underwent open surgery because of intraoperative technical constraints. In accordance with the intention-to-treat (ITT) principle, this participant was analyzed in the group to which they were originally assigned. A CONsolidated Standards Of Reporting Trials flow diagram has been added [Figure 2].

Figure 2.

CONsolidated Standards of Reporting Trials flow diagram. LARVS: Laparoscopic-assisted right VP shunt, ITT: intention-to-treat, RVS: Right ventriculoperitoneal shunt

Statistical analysis

Statistical analysis was performed using Jamovi statistical software (Version 2.4.8) (Computer Software. Sydney, New South Wales, Australia.https://www.jamovi.org). Continuous variables were summarized as mean ± standard deviation. Although some variables showed minor deviations from normality, parametric tests were applied as each study group contained more than 30 participants, and the central limit theorem supports the use of parametric methods for comparison of means in sufficiently large samples.

Categorical variables are presented as frequencies and percentages, and comparisons between the groups were conducted using the Chi-square test or Fisher’s exact test, as appropriate. A two-sided P < 0.05 was considered statistically significant.

Sample size calculation

Sample size was calculated using G*Power software (version 3.1.9.6; developed by Heinrich Heine University Düsseldorf, Düsseldorf, North Rhine-Westphalia, Germany) to detect a difference in the mean operative time between laparoscopic-assisted and open VP shunt placement. The expected group means were derived from a published comparative study by Hanna et al.[4] (mean operative time: 74.0 min in the open group vs. 50.1 min in the laparoscopic group). Assuming a two-sided independent sample t-test, α =0.05, power (1−β) =0.95, and equal allocation (1:1), the required sample size was 36 participants per group (total = 72), corresponding to Cohen’s d = 0.87. To account for potential protocol deviations and incomplete data, we aimed to recruit at least this minimum sample; 76 participants were ultimately enrolled and analyzed.

Ethical approval

The study protocol was reviewed and approved by the Institutional Ethics Committee (AIIMS/Pat/IRC/2020/464). Written informed consent was obtained from the parents or legal guardians prior to participation.

RESULTS

After satisfying the inclusion and exclusion criteria, 76 patients were randomized and allocated into two groups (38 in each group) in a 1:1 ratio. One of the patients initially randomized to the LARVS group was subsequently shifted to the RVS group owing to technical problems, thus making the total number of patients in the LRVS group 37 and the RVS group 39. An ITT analysis was performed. Hence, all 76 participants were included in the data analysis [Table 1].

Table 1.

Clinical parameters and complications

Parameter	LARVS (n=37)	RVS (n=39)	P
Age (months)	13.73±11.0	18.63±12.0	0.089
Initial head circumference (cm)	48.06±6.0	50.15±7.0	0.12
Operative time (min)	62.14±8.9	64.97±9.8	0.296
Hospital stay (days)	5.94±1.1	5.55±1.2	0.797
Noncommunicating hydrocephalus (%)	89	87	1.000
Complication	LARVS (n=37), n (%)	RVS (n=39), n (%)
Nil	30 (81.1)	30 (77)
Inguinal hernia (incidental finding)	3 (8.1)	3 (7.7)
Shunt revision	3 (8.1)	3 (7.7)
CSF leak	1 (2.7)	1 (2.6)
CSF leak + omental prolapse	0	1 (2.6)
Wound dehiscence/shunt exposure	0	1 (2.6)

RVS: Right ventriculoperitoneal shunt, LARVS: Laparoscopic-assisted RVS, CSF: Cerebrospinal fluids

The mean age (months) of the patients was 13.73 ± 11.0 in Group A and 18.63 ± 12.0 in Group B. The mean operating time in patients undergoing LARVS was 62.14 ± 8.9 min and 64.97 ± 9.8 min in patients undergoing RVS (P = 0.296). The average hospital stay in case of LARVS was 5.94 ± 1.1 days, whereas it was 5.55 ± 1.2 days in the RVS group (P = 0.797). Among the patients undergoing LARVS, 81.1% had no complications, and 77% of the RVS patients were free from any complications. Shunt revision was required in three (8.1%) LARVS patients, whereas three (7.7%) RVS group patients required shunt revision. CSF leak from the abdominal wound was observed in one (2.7%) LARVS patient compared with one (2.6%) RVS patient.

A CSF leak with omental prolapse was present in one (2.7%) patient who underwent RVS; however, none of the LARVS patients had omental prolapse. Wound dehiscence and shunt exposure were observed in one (2.6%) patient who underwent RVS, while none of the LARVS patients had this type of complication. Our comparative analysis showed comparable operative time, length of hospital stay, and complication rates between LARVS and conventional open RVS within the limits of the present sample size. The mean follow-up was 1.2 years at the time of analysis.

DISCUSSION

Hydrocephalus is one of the most common neurosurgical conditions necessitating the diversion of CSF to the peritoneal cavity via a VP shunt. Traditionally, the distal shunt is placed through an upper abdominal incision; however, this method carries the risk of a larger scar and more complications.

LARVS offers enhanced visualization of the peritoneal cavity and confirmation of distal catheter placement, with the potential to reduce postoperative complications. However, limited comparative data exist evaluating laparoscopic-assisted versus open VP shunt techniques, particularly in pediatric populations. Our comparative analysis demonstrates that LARVS provides outcomes equivalent to conventional open right ventricular shunt (RVS) with respect to operative time, length of hospital stay, and complication rates.

While not statistically significant in this study, the observation of numerically fewer distal complications and the inherent advantage of direct visual confirmation of peritoneal end placement suggest potential benefits of the laparoscopic approach. Further research with larger cohorts is warranted to determine if these translate into statistically significant clinical advantages.

These findings are in agreement with previous reports by Schucht et al. (2015)[1] and Greuter et al. (2023),[5] who emphasized improved visualization and reduced shunt malfunction rates with laparoscopic assistance. In our series, the absence of visceral injury and comparable operative time highlight the feasibility of integrating laparoscopy into routine VP shunt placement, particularly in pediatric or complex abdominal cases. Neurosurgeons are increasingly moving toward laparoscopic placement of the peritoneal end to minimize the need for subsequent revisions.[5,6,7,8] A total of 76 patients were included in the study (38 in each arm). One of the patients initially randomized into the laparoscopic group was later shifted to the open group due to some logistic problems at the time of surgery, and an ITT analysis was performed. The mean age of the patients in the LARVS group was 13.73 months and 18.63 months in the RVS group. Studies have shown that LARVS is safe in the pediatric population under 1 year of age.[9,10,11] We included patients aged >3 months of age so that creating a pneumoperitoneum does not compromise patient safety. The majority of the patients in both the groups had noncommunicating hydrocephalus: 89% in the LARVS and 87% in the RVS groups. The mean operating time was slightly longer in the RVS group than in the LARVS group. This result is in accordance with studies conducted in adult populations, which indicated that laparoscopic placement did not lead to a significantly longer operating time.[2,12,13] This may be possible as the open placement of the peritoneal end demands meticulous closure of the abdominal wound in multiple layers. The abdominal wound being very close to the shunt tubing carries the risk of being caught in the bite, leading to leakage or obstruction of the shunt tube. In contrast, the laparoscopic approach requires only the closure of a small 5-mm umbilical port and a 3-mm midclavicular port. Both of these ports stay away from the entry point of the shunt tube in the abdomen. The entire surgery in our study was performed by a single pediatric surgeon; therefore, the transition time between the general surgeon and the neurosurgeon was also curtailed, unlike in adult laparoscopic VP shunting. One patient who underwent open hernia repair was also included in the same operating time.

The average length of hospital stay was nearly the same in both the groups (5 days). This is similar to the systematic review and meta-analysis conducted by Phan et al.;[7] however, they excluded studies that included pediatric populations. The laparoscopic group recovered faster and was ready for early discharge; however, they remained for 5 days due to our antibiotic protocol.

One patient (3%) in each group had a concurrent inguinal hernia that was repaired in the same setting using an open inguinal herniotomy approach. The chances of developing inguinal hernia were higher in patients who were operated for the VP shunt before the age of 1 year.[14,15,16,17] The risk of developing an inguinal hernia in children with VP shunt was more than 10-fold higher than that in the no-shunt group during the first 2 years. Therefore, if encountered intraoperatively, it must be operated on using either open or laparoscopic methods in the same setting. Regarding the pathophysiology of inguinal hernia development, we hypothesized that it may be related to the increased fluid volume in the peritoneal cavity, resulting in elevation of the intra-abdominal pressure, in conjunction with the presence of a patent processus vaginalis.

It has been reported that almost 80%–85% of patients in the pediatric age group undergo shunt revision surgery during a 15-year follow-up.[18] Out of the total revisions, 15% were due to complications related to the distal end of the shunt. In the index study, we found a significantly lower incidence of shunt revision (7% in both the groups); one apparent reason is the shorter follow-up. Other reasons for the lower incidence are that redo cases were excluded from the study, and only the virgin abdomen was considered. However, many studies in the adult population claim a significantly lower incidence of distal shunt-related complications after laparoscopic distal insertion of the VP shunt.[7,19,20,21] This marked difference between the pediatric and adult populations could be because of the naturally different habitus and size between adults and pediatric patients. Several studies have reported distal catheter-related complications in VP shunts, including catheter kinking, tissue ingrowth through slit valves, peritoneal adhesions, and CSF pseudocyst formation. These problems may lead to shunt malfunction and often require revision surgery, with laparoscopy providing the advantage of direct visualization and targeted management.[19,20,21]

CSF leak from the abdominal wound was observed in one (2.7%) LARVS patient compared with one (2.6%) RVS patient. Although the difference was not statistically significant in this study, previous literature suggests that CSF leaks are more commonly expected in the open surgery group owing to the larger wound size and longer suture line.[22] All patients with CSF leaks from the abdominal wound were managed conservatively. Leakage along with omental prolapse was present in one (2.7%) patient undergoing RVS; however, none of the LARVS patients had omental prolapse. All patients with omental prolapse underwent revision surgery. Wound dehiscence and shunt exposure were observed in one (2.6%) RVS patient, while none of the LARVS patients had this complication. Shunt revision was required for this complication. One patient in the RVS group underwent shunt revision for wound dehiscence and subsequent shunt exposure from the abdominal entry point. Abdominal wound complications such as CSF leakage or tissue prolapse are more frequently encountered with the open technique as the distal catheter is inserted blindly, whereas laparoscopic-assisted placement provides direct visualization and has been associated with fewer abdominal complications and lower distal shunt failure rates.[22,23]

Limitations

The limitation of the index study was its relatively small sample size and shorter duration of follow-up. The results are based on a single-center experience, which may not be generalizable to other facilities. The results were not statistically significant; however, longer follow-ups are required to determine the actual incidence of complications such as shunt migration and pseudocyst formation. While the study was adequately powered for operative time, it may be underpowered to detect smaller differences in less frequent outcomes such as complications.

CONCLUSION

LARVS appears to be a safe and minimally invasive technique with outcomes comparable to those of the conventional open approach. A key advantage of the laparoscopic method is the ability to directly visualize the distal catheter within the peritoneal cavity and confirm CSF flow, which may help reduce the likelihood of distal catheter malposition, kinking, or obstruction along the long intracorporeal course of the shunt. Additionally, laparoscopy allows for rapid inspection of the abdominal cavity, enabling the identification of associated conditions, such as inguinal hernias, that may predispose to complications, such as shunt migration or extrusion.

Although the laparoscopic group demonstrated a numerically lower complication rate in our series, the difference did not reach statistical significance. Therefore, the findings suggest that the laparoscopic approach is noninferior to the conventional open technique in terms of safety and complication rates. Given the limitations of the study, including the relatively small sample size and lack of statistically significant differences between the groups, larger prospective studies are required to further clarify whether the laparoscopic approach confers a definitive clinical advantage over the traditional open method.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.