Robot-Assisted Pull-Through for Anorectal Malformations: Comparative Observational Study of Functional Outcomes with an Open Approach

Abstract

Introduction:

Robotic surgery has gained acceptance in the field of pediatric surgery but is still under assessment. Some limitations of this device are particularly encountered when performing specific tasks in small cavities, such as neonatal pelvis. The aim of this study was to compare the functional results of robot-assisted anorectal pull-through (RAARP) with posterior sagittal anorectoplasty (PSARP) in children with “high” types of anorectal malformations (ARMs).

Materials and Methods:

In this multicenter experience, we reviewed the patients operated for ARMs using the da Vinci® system between 2007 and 2020 in our national robotic program. Two groups of patients according to the surgical technique (robotic versus open) were compared based on the postoperative outcomes and long-term functional results using Kelly and Krickenbeck scores at 3 years of age.

Results:

Ten patients operated using RAARP were compared with 10 patients operated using PSARP (mean weight 8.1 ± 1.2 kg versus 8.6 ± 1.1 kg, respectively). The two groups were comparable in terms of the ARM classification and patient demographics. The clinical Kelly score was significantly lower for the PSAAP group (P = .012). The Krickenbeck constipation score was significantly lower for the RAARP group (P = .02), whereas no statistical difference was found for the soiling score and voluntary bowel movements.

Conclusions:

A concomitant laparoscopic approach using a robotic platform appears to be an alternative technique to the criterion standard for performing anorectal malformation surgery with satisfactory functional results. The enhanced potential of preserving perirectal nerves requires confirmation through longer follow-up studies focusing on functional assessment.

Introduction

Anorectal malformations (ARMs) are rare (1/4000 births) but generally necessitate surgical repair.¹ ARMs comprise a broad spectrum, ranging from “low” types to “high” types, for which the key issue is the long-term functional results. This long-term function depends on the type of ARM as well as the abdominal component of the surgical repair.²

“High” types of ARM are treated with two stages of surgical procedures including stoma, malformation repair, and then stoma closure. The gold standard for malformation repair was described by Pena in 1982,³ using an open approach by ventral decubitus known as the posterior sagittal anorectoplasty (PSARP) approach.⁴ It is difficult to achieve abdominal repair of ARMs with a dedicated pelvic approach. A concomitant laparoscopic technique was hence proposed to achieve treatment of the fistula by separation of the rectal stump and the urogenital component.⁵ This has been reported to be a safe and feasible technique in male neonates.⁶ This concomitant abdominal step was then recognized as providing potential advantages and improved results⁷ compared with the isolated pelvic approach for “high” types of ARM. Furthermore, the results tend to favor laparoscopic pull-through compared with PSARP in terms of functional outcomes.^2,8

Since the era of robotic surgery, this platform has gained acceptance in the field of pediatric surgery, although it is still under assessment. Some limitations of this device are particularly encountered when performing specific tasks in small cavities, such as neonatal pelvis. Several cases have been performed since the first description by Meehan and Sandler.⁹ Only three studies dedicated to surgical ARM treatment have been reported^10–12 for robot-assisted anorectal pull-through (RAARP), and no study to date has compared RAARP versus the PSARP approach in terms of functional results. The aim of this study was to report the experience of the robotic treatment of ARMs in the neonatal period since the beginning of the robotic program. The primary outcome was the functional status at 3 years of age. The secondary outcomes were the peri-- and postoperative complications.

Material and Methods

A retrospective multi-institutional study was performed since the beginning of the robotic program in France in 2007. All of the patients operated for “high” types of ARM between January 2007 and June 2020 were recruited in this study. This study was approved by our Institutional Ethics Committee (Reference number 44-2023-7).

In each of the pediatric surgery centers where this study took place, two groups of patients according to the surgical technique (open versus robotic) were compared based on the surgical outcomes and the long-term functional results using Kelly,¹³ and Krickenbeck,¹⁴ scores at 3 years of age.

Operative protocol

The preoperative imaging protocol consisted of pelvic sonography and MRI to define the anatomical abnormalities, which were classified according to the International Conference for the Development of Standards for the Treatment of ARMs.¹⁴ Surgical management consisted of three stages of surgical procedures, comprising colostomy and urinary endoscopy at birth before scheduling the surgical repair of the malformation between 3 and 6 months of age. Since the beginning of the robotic program, robotic was favored compared with standard laparoscopy. RAARP was performed with a da Vinci^® SI and Xi according to Georgeson et al.⁵ and enhanced by means of robotic technology,¹² in order to preserve the nervous bundles. A camera was inserted in the umbilical, and two 8 mm trocars were inserted in the flanks inwardly of the stoma. Precise dissection started at the peritoneal reflection line. Skeletonization of the fistula under direct magnified vision was performed step-by-step in order to decide on a knot closure or spontaneous healing process. An endoloop anchoring knot can be placed at the end of the rectum to assist further pull-through. The placing of the neoanus was guided by means of electrostimulation, and a 12 mm pelvic trocar was inserted before the pull-through was performed and the robot undocked. Anoplasty was carried out without the need to change the operative field for the perineal step, as shown in the video for this article. Closure of the stoma was performed 6–8 weeks later.

PSARP was preferred in the case of female patients, robotic platform unavailability, and patients’ laparoscopic contraindications. Among the patients operated on during the same period by PSARP, a control group was selected. Most patients of this group were targeted as patients with ARM and associated abnormalities or other conditions with consequent laparoscopic contraindications. They were matched in terms of anatomical shape and type of ARM, weight, gender, age at surgery, and comparable associated abnormalities. Both procedures were performed by the same group of surgeons. The data for the two groups included the gender, age, and weight at the time of the surgery, associated anomalies, the type of management (RAARP versus PSARP), the total operative time, the hospital stay, the duration of bladder catheter drainage, the perioperative course, the functional results, and the follow-up.

Evaluation of the outcomes

Functional outcomes were prospectively assessed after 2 years of age every 6 months in consultation. Kelly’s clinical scoring: Three parameters¹³ were used to evaluate the outcomes: the parents were asked about incontinence and fecal staining, and these parameters were also reported by the surgeons, whereas the squeezing sphincter force was evaluated by the surgeon, and each of these parameters was divided into three grades. The Krickenbeck criteria¹⁴ assessed voluntary bowel movements (a), evaluated using three questions in order to score the patient from 0 to 3. The two other parameters (soiling [b] and constipation [c]) were categorized into four grades: from 0 (absence of symptoms) to 3 (maximal symptoms intensity).

Statistical methodology

The statistical analyses were performed using Microsoft Prism 5 software (GraphPad Software, San Diego, California, USA). All tests were two-sided, and a P value ≤.05 was considered to be statistically significant. The patient characteristics are reported as percentages for the qualitative variables and as means ± the standard deviation for the continuous variables. A paired t-test and Mann–Whitney test were used to compare the quantitative data and Fisher’s exact test was used for the qualitative variables.

Results

Description of the population

Only two centers were found to perform RAARP during this period in the national program. A total of 550 patients were operated on with the robot in these two pediatric surgical centers during this period for abdominal and thoracic procedures. During this period, a total of 103 patients (52 boys and 51 girls; six had suspected ARM at prenatal diagnosis) were surgically managed by the same surgeons for ARM in these two centers. Of these, 56 were “high” types, 44 of whom were operated using PSARP and two with a concomitant standard laparoscopic approach.

Surgical results

Ten patients were operated on using RAARP, and their data are summarized in Table 1. All procedures were robotically completed without the need for conversion to laparoscopic or open technique. No mortality or intraoperative complications occurred. The mean docking time was 44 ± 7 minutes and the mean console time was 99 ± 34 minutes. In six patients, the fistula was left open. The Foley catheter was removed after 4.1 ± 1.3 days. Anal dilatation started at 3 weeks postoperatively. Two postoperative complications occurred: one anal stenosis that required two sessions of dilatation under general anesthesia, and one case of partial mucosal prolapse. All the patients had their colostomies closed after 8.3 ± 1.3 weeks.

Table 1.

Cases of Patients with Robot-Assisted Anorectal Pull-Through Procedures for “High” Types of Anorectal Malformations

		Weight	Age	Operative time	Console time	Hospital stay	Bladder catheter	Clinical groups of fistula according to international classification (Krickenberg)	Associated abnormalities	Complications	Colostoma closure	Follow-up
Patient	Gender	Kg	Months	Minutes	Minutes	Days	Days		Associated abnormalities	Complications	Weeks	Months
1	M	8.2	7.2	230	85	5	5	Rectovesical fistula	Coccyx agenesia	0	8	71
2	M	10.3	22	255	110	5	5	Rectourethral fistula	Fallot’s tetralogy	Colic atresia	7	65
3	M	6.2	7.2	180	120	8	7	Rectovesical fistula	No	0	10	68
4	F	7.6	11.8	100	50	6	5	Rectovaginal fistula	No	0	11	42
5	M	7.9	8.1	180	100	4	4	Rectourethral fistula	Buried penis	0	7	38
6	M	9.1	4.3	190	110	4	3	Rectourethral fistula	Spinal/filum cord lipoma	0	8	37
7	M	7.6	4.7	116	40	3	3	Rectourethral fistula	No	0	8	32
8	M	9.1	15.5	320	155	3	3	Rectovesical fistula	Cutaneous urethral fistula	0	7	34
9	M	8.6	2.8	245	120	3	3	Rectovesical	VACTERL	0	9	36
10	M	6.5	6.2	185	100	3	3	Rectourethral fistula	Hypospadias	Mucosal prolapse	8	39
Mean ± SD	90%	8.1 ± 1.2	8.8 ± 5.9	201 ± 69	99 ± 34	4.4 ± 1.6	4.1 ± 1.4		70%	10%	8.3 ± 1.3	51.5 ± 16.1

M, male; F, female.

In the PSARP group, 10 patients (Table 2) were selected to constitute a paired control group and their data are compared with the RAARP group in Table 3. No statistical differences were found according to preoperative clinical data. Three postoperative complications occurred: one anal stenosis that required three sessions of dilatation under general dilatation, one case of bladder dysfunction requiring 1 month of bladder diversion using a Foley catheter, and one case of partial mucosal prolapse. All the patients had their colostomies closed after 9.7 ± 2.6 weeks. A significantly shorter hospital stay was found for the RAARP group compared with the PSARP group: 4.4 ± 1.6 days versus 7.3 ± 3.1 days, respectively; P = .018. During this period, three patients were treated using standard laparoscopy—two due to limited access to the robotic platform and one due to the unavailability of an experienced robotic surgeon.

Table 2.

Cases of Patients with Posterior Sagittal Anorectoplasty for “High” Types of Anorectal Malformations

Patient	Gender	Weight	Age	Operative time	Hospital stay	Bladder catheter	Clinical groups of fistula according to international classification (Krickenberg)	Associated abnormalities	Complications	Colostoma closure	Follow-up
Patient	Gender	Kg	Months	Minutes	Days	Days		Associated abnormalities	Complications	Weeks	Months
1	M	10	6	120	5	5	Rectourethral fistula	None specified genetic disorder	0	8	71
2	M	9	7	110	6	5	Rectourethral fistula	Pallister Killian syndrome	0	7	68
3	F	6.5	15	190	4	4	Rectovaginal fistula	Agenesis of the corpus callosum	Anal stenosis	8	98
4	M	5.7	13	290	5	5	Rectourethral fistula	Cardiac malformation	0	8	59
5	M	5.8	3	180	5	5	Rectourethral fistula	Renal malformation	0	9	54
6	F	6.7	8	120	9	28	Rectovesical	No	Bladder voiding dysfunction	14	97
7	M	7.1	3	120	5	5	Rectourethral fistula	Spinal cord lipoma	0	9	105
8	M	9	3	190	12	10	Rectovesical fistula	Sacral agenesis	0	13	78
9	M	10	4	210	12	10	Rectovesical	Undescended testis	Mucosal prolapse	13	119
10	M	9	13	210	10	7	Rectourethral fistula	No	0	8	49
Mean ± SD	80%	8.6 ± 1.1	7.5 ± 4.6	174 ± 57	7.3 ± 3.1	8.4 ± 7.2		80%	30%	9.7 ± 2.6	79.8 ± 23.7

M, male; F, female.

Table 3.

Characteristics and Functional Outcomes of the Two Groups of Patients

Data	RAARP	PSARP	Difference
Number of patients	10	10
Weight	8.1 ± 1.2	8.6 ± 1.1	P = .41
Spinal anomalies (%)	2	2
Sacral abnormalities (%)	5	4
Age at surgery (months)	9 ± 5.9	7.5 ± 4.6	P = .55
Operative time (min)	201 ± 69	174 ± 69	P = .35
Hospital stay (days)	4.4 ± 1.6	7.3 ± 3.1	P = .018
Follow-up (months)	46.2 ± 15.3	68.5 ± 26.7	P = .62
Functional outcomes at 3 years of age
Krickenbeck voluntary bowel movements			P = .25
Feeling of urge	80%	50%
Capacity to verbalize	60%	60%
Hold the bowel movement	90%	60%
Krickenbeck soiling score			P = .29
No soiling	0%	10%
Grade 1	60%	40%
Grade 2	30%	20%
Grade 3	10%	30%
Krickenbeck constipation score			P = .02
No constipation	50%	0%
Grade 1	40%	30%
Grade 2	10%	60%
Grade 3	0%	10%
Kelly clinical assessment score	4.5 ± 0.5	3.8 ± 0.9	P = .012

RAARP, robot-assisted anorectal pull-through; PSARP, posterior sagittal anorectoplasty.

Functional results

The clinical Kelly score was significantly lower for the PSARP group (Table 3). The Krickenbeck constipation score was significantly lower for the RAARP group, whereas no statistical difference was found for the soiling score or in terms of voluntary bowel movements (Table 2).

Discussion

This study compared, for the first time, functional outcomes between RAARP and PSARP in children, underscoring better outcomes for RAARP at 3 years of age. It confirms the feasibility and safety of robotic technology for small children, even in the pelvic area. It underlines the probable advantage of combined laparoscopic and perineal approaches for ARM compared with an isolated open approach.

The limitations of this study are the small number of patients, the absence of a standard laparoscopic control group, as well as the absence of functional data after 3 years of age.

Limitations of the robot

Limited access to the robotic platform precluded systematic RAARP for all patients with MAR during this study period. Due to limited platform access, two patients were treated by standard laparoscopy. This access limitation is probably the cause of the very limited number of patients with RAARP since the beginning of the robotic program in Europe. In the two centers, eight patients with associated abnormalities had contraindications for laparoscopic procedures.

Robotic advantages

The size of the trocars did not appear to be a limitation for these neonatal patients, nor was the length of the arms. None of the stomas had to be displaced during the robotic procedure, and no conversion occurred. Our data suggest that surgical management and the functional outcomes of RAARP are comparable with those of standard laparoscopy for “high” ARM types, for which this laparoscopic procedure appears to be mandatory, as claimed previously.²

In the current context of rationalization of the means, some pediatric surgeons have questioned the benefits of robotics compared with standard 3 mm laparoscopy. A robotic platform is thought to facilitate clear dissection between different anatomical layers. Clear laparoscopic individualization of the fistula¹⁵ is all the more obvious when magnified and viewed on a 3D robotic console. This allows clear dissection of the muscular fibers and enables detection of the absence or presence of a mucosal channel that can be closed. It also allows clear individualization of the pelvic plexus and Denonvillier’s fascia, which is a critical step for proceeding to the nerve-sparing technique. This was initially devised by urologists¹⁶ and consists of dividing the rectal muscular layer from the rectal fascia proper.

3D laparoscopy has been reported for anorectal pull-through in children to reduce the overall mental strain, the operative time, and particularly the fistula dissection step compared with 2D laparoscopy.¹⁷ It presents the disadvantage, however, of requiring a larger 10 mm camera and physical discomfort for the surgeon. Another advantage of a robotic platform is the sparing musculoskeletal effect on the surgeon’s quality of life. Experienced laparoscopic surgeons are generally acutely aware of the ergonomic discomfort encountered when using a 3 mm camera in tiny spaces, with consequent long-term physical impacts after such repeated lengthy procedures.¹⁸

Prospects

Chang et al.¹² reported that colostoma closure was performed at the same time as RAARP. This first experience could encourage pediatric surgeons to perform concomitant RAARP and stoma closure. The current results do not allow it to be concluded that robotic tools enhance the quality of dissection and provide better long-term functional results. However, the robotic perspective using augmented reality by the superimposition of pelvic nervous anatomical structures and the operative field in the console could enhance the potential of this very precise dissection. Those technologies could favor image-guided pelvic surgery as a result of MRI-based 3D autonomous innervation reconstruction,^19,20 which may be highly overhauled in “high” types of ARM.

Conclusion

A robotic approach to anorectal malformation corrective surgery appears to be a safe alternative technique to the criterion standard, providing comparable functional outcomes. The enhanced potential of preserving perirectal nerves and the sphincter effect technique require confirmation through longer follow-up studies focusing on functional results including an adult period assessment.

Footnotes

Acknowledgments

The draft article was reviewed by a native English speaker (Sophie Domingues, Koonec°, Barcelona, Spain).

Authors’ Contributions

Q.B. and P.M.: Carried out the data collection. H.L. and Q.B.: Conceptualization, methodology. P.L., J.H., and K.B.: Data curation. A.B. and P.M.: Writing—original draft preparation. H.L.: Supervision and validation. Q.B.: Writing and editing.

Disclosure Statement

The authors declare that they have no conflicts of interest.

Funding Information

No funding was received for this article.

Supplementary Material

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