Original Article Laparoscopic pyloromyotomy: Lessons learnt in our first 101 cases Abhilasha Tej Handu, Vinay Jadhav1, Deepak J1, Jayalaxmi S Aihole1, Gowrishankar1, Narendrababu M1, S Ramesh1, KR Srimurthy1 Department of Surgery, Bharti Hospital and Research Centre, Pune, Maharashtra, 1Department of Pediatric Surgery, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India Address for correspondence: Dr. Abhilasha Tej Handu, Department of Surgery, Bharti Hospital and Research Centre, Dhankawadi, Satara Road, Pune - 411 043, Maharashtra, India. E-mail: [email protected]
ABSTRACT Aim: To analyze our experience with laparoscopic pyloromyotomy for infantile hypertrophic pyloric stenosis for the lessons that we learnt and to study the effect of learning curve. Materials and Methods: This is a retrospective analysis of case records of 101 infants who underwent laparoscopic pyloromyotomy over 6 years. The demographic characteristics, conversion rate, operative time, complications, time to first feed and post-operative hospital stay were noted. The above parameters were compared between our early cases (2007-2009) (n = 43) and the later cases (2010-2013) (n = 58). Results: 89 male and 12 female babies ranging in age from 12 days to 4 months (mean: 43.4 days) were operated upon during this period. The babies ranged in weight from 1.8 to 4.7 kg (mean: 3.1 kg). Four cases were converted to open (3.9%): three due to mucosal perforations and one due to technical problem. The mean operative time was 45.7 minutes (49.7 minutes in the first 3 years and 43.0 minutes in the next 3 years). There were 10 complications-4 mucosal perforations, 5 inadequate pyloromyotomies and 1 omental prolapse through a port site. All the complications were effectively handled with minimum morbidity. In the first 3 years of our experience the conversion rate was 9.3%, mucosal perforations were 6.9% and re-do rate was 2.3% as compared to 0%, 1.7% and 6.9%, respectively, in the next 3 years. Mean time for starting feeds was 21.4 hours and mean post-operative hospital stay was 2.4 days. Conclusion: Laparoscopic pyloromyotomy is a safe procedure with minimal morbidity and reasonable operative times. Conversion rates and operative times decrease as experience increases. Our rate of inadequate pyloromyotomy was rather high which we hope to decrease with further experience.
Access this article online Website: www.jiaps.com DOI: 10.4103/0971-9261.142009 Quick Response Code:
KEY WORDS: Infantile hypertrophic pyloric stenosis, laparoscopy, pyloromyotomy
INTRODUCTION Infantile hypertrophic pyloric stenosis (IHPS) is a common condition in infants, affecting approximately 1 to 3 per 1000 live births.[1] Ramstedt’s pyloromyotomy, described in 1912, has remained the gold standard
for treatment of IHPS over the last century.[2] The laparoscopic approach to this procedure was described by Alain et al. in 1991.[3] With advances in the field of minimally invasive surgery in neonates and infants, this approach has gained popularity and a number of centers around the world have reported the safety
Cite this article as: Handu AT, Jadhav V, Deepak J, Aihole JS, G, Narendrababu M, Ramesh S, et al. Laparoscopic pyloromyotomy: Lessons learnt in our first 101 cases. J Indian Assoc Pediatr Surg 2014;19:213-7. Source of Support: Nil, Conflict of Interest: None declared.
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and feasibility of the procedure. Advantages of the laparoscopic approach have been cited as lesser time to full feeds, lesser analgesic requirement, shorter length of hospital stay and better cosmesis.[4,5] We undertook this study to analyze our experience of performing laparoscopic pyloromyotomy (LP) for IHPS. We also studied the effect of learning curve on operative time, conversion rate and complications. This is the largest reported series in the Indian literature so far.
MATERIALS AND METHODS We retrospectively analyzed the case records of infants who underwent LP for IHPS at our institute between April 2007 to March 2013. Demographic characteristics like age, sex, weight at presentation and duration of symptoms were noted. All patients were diagnosed on clinical grounds and confirmed with ultrasonography (USG). Electrolyte and acid base abnormalities were corrected before surgery.
Operative technique The procedure was the same as that described and practised in the standard literature. The child was given general endotracheal anesthesia. A nasogastric tube was placed to empty the stomach. The infant was placed supine with the surgeon standing at the foot of the table and the monitor placed at the head end. A short 5-mm optical port was inserted through the umbilicus by the open technique for a 20-cm 30-degree 4-mm telescope and one 3-mm right upper quadrant working port was inserted. A percutaneous stitch was taken through the falciform ligament to retract the liver out of the field. A 3-mm stab incision was made in the left subcostal area for direct insertion of the arthrotomy knife and the pyloric spreader. The duodenum was stabilized with a non-traumatic grasper and the arthrotomy knife used to make an incision in the middle of pylorus. The knife was then withdrawn into the arthrotome and the blunt tip was thrust into the pyloric incision and twisted to make adequate space for the pyloric spreader which was then used to gently split the pyloric muscle till the mucosa was seen to be bulging. Care was taken to ensure adequacy of the pyloromyotomy at both gastric and duodenal ends. A satisfactory pyloromyotomy was confirmed by independently moving the two pyloric edges. Air was insufflated through the nasogastric tube to check for any breach of mucosal integrity. Port sites were closed. Feeds were started within the first 24 hours and gradually increased as tolerated by the child. The child was discharged once full feeds were achieved. Seniority of the operating surgeon, operative time, conversion rate, time to first feed, post-op hospital 214
stay and complications were noted from the records. Surgeons were considered senior when they had at least 5 years of experience with laparoscopic surgery. Juniors performing the procedure were assisted by one of the four senior surgeons at all times. We divided our study patients into two groups: Group I: First half (3yrs) of study period; n = 43. Group II: Second half (next 3 yrs) of the study; n = 58. Operative time, conversion rate, complications, time to first feed and hospital stay were compared between the two groups.
Statistical analysis Continuous data was expressed as mean ± standard deviation (SD). Medians were calculated for skewed data. Study patients were divided into two groups as mentioned above. We used SPSS version 17.0, Stata version 13.0 statistical software to find the significance between two groups with respect to various paramneters. Two independent sample t-test and chi-square test were used to compare age and sex variations between the two groups. Operative time, time to first feed and hospital stay between two groups were compared using the Mann-Whitney U test. Complication rates and conversion rates were compared between the two groups using Fisher’s exact test.
RESULTS We performed 101 laparoscopic pyloromyotomies on 89 male (88.1%) and 12 female (11.9%) infants during this period. The mean age of the infants was 43.4 ± 20.2 days (range: 12 days to 4 months) and the mean weight at surgery was 3.1 ± 0.6 kg (range: 1.8 to 4.7 kg). Symptoms ranged in duration from 3 to 45 days (Mean ± SD: 13.1 ± 9.2 days). Sixty-nine cases (68.3%) were performed by senior surgeons and 32 (31.7%) were performed by junior surgeons under supervision. Four cases were converted to open (3.9%)-three due to mucosal perforation and one due to technical problem with insufflation. Mean operative time was 45.7 ± 17.4 minutes (range: 15 to 105 minutes). The longest operative time was in the case of a child who had a mucosal perforation which was sutured laparoscopically with an omental patch and a fresh pyloromyotomy made on the inferior aspect. The operative time reduced from 49.7 minutes to 43.0 minutes in the latter half of our experience. This difference was found to be statistically significant (P value = 0.015). The operative time of the four senior surgeons decreased from 49.2 ± 12.3 minutes (range: 20-75 minutes) to 37.0 ± 17.6 minutes (range: 15-75 minutes).
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Handu, et al.: Experience with laparoscopic pyloromyotomy
Four patients (3.9%) had mucosal perforation of which one was managed successfully laparoscopically while the remaining three were converted to open. Five children (4.9%) had inadequate pyloromyotomy requiring re-do surgery. Two re-do surgeries were performed laparoscopically with a smooth post-operative recovery. Another was attempted laparoscopically but had to be converted to open. Two re-dos were performed by the open technique. The children with inadequate pyloromyotomy presented with persistent vomiting. Two patients had frequent vomiting in the immediate post-operative period and their operative videos were reviewed. It was felt that both these children may have had inadequate pyloromyotomies hence it was decided to re-operate on them. They were operated on the 4th and 5th post-operative day, respectively. Two patients presented about 3 weeks after the first surgery. They had occasional episodes of vomiting starting from the early post-operative period which was initially managed medically. However, as the frequency of vomiting increased they were evaluated with a contrast study which showed a distended stomach with delayed passage of contrast across the pylorus. One patient had a very delayed presentation about 6 weeks after the first surgery. This child underwent a repeat USG and contrast study before being taken up for re-do surgery. One child had omental prolapse through the left subcostal port site on the 2nd post-operative day. One child had self-limiting intra-operative bleeding from the pyloromyotomy site. The child required a postoperative blood transfusion due to significant fall in the hemoglobin but there was no hemodynamic instability or further fall in hemoglobin after the transfusion. USG did not show any collection. The child had an otherwise uneventful postoperative course. There were no wound infections in any patient. Mean time for starting feeds was 21.4 ± 16.2 hours (range: 8 hours-5 days). Few babies had a couple of episodes of emesis on the 1st post-operative day. Mean post-operative hospital stay was 2.4 ± 2.0 days (range: 1-10 days). Reasons for prolonged stay included delayed initiation of feeds in the child with mucosal perforation sutured laparoscopically, sepsis and ileus in two patients and prolonged vomiting in one child. Forty-three laparoscopic pyloromyotomies were performed in the first 3 years of our experience (42.6%) and 58 (57.4%) in the next 3 years. The demographic data between the two groups has been compared in Table 1. Table 2 shows the comparison of outcomes between the two groups. Operative time and conversion rates were
significantly lower in Group II as compared to Group I. However, complication rates did not show any such difference between the groups. In contrast, the rate of inadequate pyloromyotomy was higher in the second half of our study. Time to first feed and duration of hospital stay were not significantly different between the groups.
DISCUSSION Laparoscopic pyloromyotomy (LP) is a technically simple, feasible and safe procedure which is being performed by many centers across the world. Various modifications of the technique have been described in literature. A good alternative in centers where the pyloromyotomy knife and spreader are not available is the technique described by Jain et al.[6] They used the hook electocautery to make the initial pyloric incision and a 3-mm Maryland forceps was used to split the pyloric muscle after incision. We started performing the laparoscopic procedure in 2007, and currently almost all pyloromyotomies are being performed by laparoscopy Table 1: Comparison of demographic data between the two groups Group I (2007-2009) (n = 43) Age (days) 45.3±21.0 (12-90) Mean±SD (Range) Weight (kg) 3.2±0.6 (2-4.5) Mean±SD (Range) Sex (M:F) 36:7 Senior surgeon 39 (90.7%) Junior surgeon 4 (9.3%)
Group II (2010-2013) (n = 58)
P value
42.0±19.6 (15-120)
0.422
3.1±0.6 (1.8-4.7)
0.649
53:5 30 (51.7%) 28 (48.3%)
0.450 —
Table 2: Comparison of outcomes and complications between the two groups Group II (2010-2013)
P value
4(9.3%) 0 (0%) 49.74±12.03 43.02±19.86 (20-75) (15-105) 45.0 40.0 16.88±3.18 22.38±17.77 (12-20) (8-120) 18 18 2±0.94 2.59±2.31 (1-3) (1-10) 2 2 Complications 3(6.9%) 1(1.7%) 1(2.3%) 4(6.9%) 0 1(1.7%) 0 1(1.7%)
0.030*
Group I (2007-2009) Conversion Operative time (min) Mean±SD (Range) Median Time to first feed (hrs) Mean±SD (Range) Median Hospital stay (days) Mean±SD (Range) Median Mucosal perforation Inadequate LP Wound complications Bleeding
0.015*
0.125
0.844 0.309 0.391 0.999 0.999
*P value < 0.05 is significant
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at our centre. Open pyloromyotomies are performed occasionally for the purpose of training of residents. There were no contraindications to performing LP in any of our patients. We analyzed the results of the 101 LP’s performed by us over the last 6 years. We divided our experience into two halves to assess the effect of learning curve. Our overall conversion rate of 3.9% (4/101) was comparable to that reported by other authors.[7-9] Three of these conversions were due to mucosal perforations. We have not had a single conversion in the last 3 years (significant fall from 9.3% to 0%). As our experience grew we were able to significantly decrease the rate of mucosal perforations (6.9% to 1.7%). In fact, the only mucosal perforation we had in the last three years was also managed laparoscopically. Van der Bilt et al. in their study of the impact of experience on LP also showed a fall in mucosal perforation from 8.3% to 0.7% with time.[10] Oomen et al. have also shown a similar fall in mucosal perforation rates with experience.[7] Our operative times were comparable to some studies,[7] but longer than that reported in others.[9,11] There was a decrease in operative times with experience in spite of the fact that more junior surgeons performed the surgeries in the second half. The operative times of the senior surgeons were lower than the overall times and decreased significantly with experience. Van der Bilt et al. have reported no significant difference in mean operative time with time, but operative time per surgeon dropped with experience.[10] Time to full feeds and post-operative length of hospital stay have been studied as markers of post-operative recovery by many authors.[5,11,12] As most children are usually discharged once they tolerate full feeds, time to full feeds and length of hospital stay are usually similar in most patients. Hence, we decided to record time of initiation of feeds, with duration of post operative hospital stay being indicative of time to full feeds. Time to first feed and duration of hospital stay did not significantly change with experience, as is also reported by another study.[9] Oomen et al. have noted that every hospital has different standardized protocols for a feeding regimen, which makes an objective comparison difficult.[13] Five children (4.9%) had inadequate pyloromyotomy requiring re-do surgery. This was comparable to previous reports which have shown a slightly higher rate of incomplete pyloromyotomy after laparoscopy as compared to the open procedure.[4,5,8,10,14-16] However, except for the study by Leclair et al., [15] no other prospective randomized control studies has shown 214
a statistically significant difference in the rate of inadequate pyloromyotomy between the open and laparoscopic methods.[5,11,12] We had a higher rate of inadequate pyloromyotomy in the second half of our study (6.9% vs 2.3%), leading to 4 re-do surgeries for the same. We have not been able to find a suitable justification for this. All these cases had inadequate splitting of the pyloric muscle at the gastric end. These infants had a longer duration of symptoms (21 days vs 12.4 days) as compared to those with adequate pyloromyotomies. In all except one of these cases we observed a marked difficulty in splitting the muscle fibers which we thought was due to the muscles being more fibrotic and difficult to split. However, this was a subjective finding noted by the operating surgeon. It may have been a phenomenon of being overconfident or fear factor (of opening the mucosa). All laparoscopic procedures were recorded and reviewed in order to avoid this complication. Subsequent to this we are making sure that we extend the myotomy adequately proximally. The difference in rates of wound complications and bleeding was not significantly different between the two groups. Initial studies have shown a wound complication rate (dehiscence and infection) as high as 6.7% after OP.[17] Although recent studies have not shown such a high rate of wound complications even with OP, Sola et al. have found that the rate of total complications was significantly lower with LP than OP, due primarily to a lower wound complication rate.[4] We were previously closing only the skin in the 3-mm incisions, however after this incident we have been closing the fascia as well. With experience, we have begun to tackle mucosal perforation and inadequate pyloromyotomies by laparoscopy. This has not been previously reported in the literature. One mucosal perforation and two re-do pyloromyotomies have been successfully completed laparoscopically, both in the latter half of our experience. Our initial cases were performed mostly by senior surgeons who already had advanced laparoscopic skills. Junior surgeons and trainees were also gradually taught the procedure and eventually performed it in comparable times with no additional increase in complications. We feel that LP is a simple procedure which can be easily mastered by trainees. The randomized control trial comparing OP (circumumbilical incision) with LP by Hall et al. had 32 of 87 (37%) laparoscopic procedures done by a trainee under supervision.[5] Comparisons of time to full feed or postoperative length of stay after procedures done by trainees and non-trainees failed to identify any significant difference. The frequency of
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serious complications was similar in patients operated by trainees and non-trainees. In our study, as all junior surgeons were always assisted by a senior surgeon we did not feel it was right to compare the outcomes of junior versus senior surgeons. Although not evaluated in our study, analgesic requirement has been found to be significantly lesser in patients undergoing LP as compared to OP. There is higher parental satisfaction of scars on the visual analog scale showing a definite cosmetic advantage of LP over OP (circumumbilical incision).[5] In fact in the above-mentioned study, a prospective randomized control trial, the trial was halted before full recruitment because of significant treatment benefit in the LP group at interim analysis. They concluded that both OP and LP were safe but LP had advantages over OP, without additional complications or cost implications and recommended it in centers with suitable laparoscopy experience. A more recent meta-analysis of the randomized control trials comparing OP versus LP has found no clear benefit of LP over OP.[13] They have concluded that LP might be acknowledged as the standard of care if the major postoperative complication rate is low and that the choice of procedure depends on discretion of the surgeon. A study by Kim et al. has studied the effect of learning curve and found that LP has a steep learning curve, especially for the first 15 patients. Operative time decreases and becomes more consistent after about 30 cases.[9] Another study by Oomen et al. has found the learning curve in their series to be about 35 cases.[7] We could not arrive at such a number as multiple surgeons including trainees performed the surgeries in our series. Thus, to conclude, laparoscopic pyloromyotomy is a safe procedure which can be performed in pediatric surgical centers with some degree of laparoscopic experience. Operative times are reasonable with a comparable complication rate. The procedure can be easily learnt by junior surgeons and trainees. Although we demonstrated a fall in operative time and conversion rate with experience, our rate of inadequate pyloromyoyomy was rather high. We hope to decrease this with the lessons learnt and further increase in experience. We have also begun to tackle mucosal perforation and inadequate pyloromyotomy laparoscopically.
Laparoscopic pyloromyotomy is yet to be considered the standard of care for management of IHPS, but it is safe, results are comparable with open surgery and gives excellent cosmesis in the long term. As more pediatric centers are adopting this approach, LP is expected to become the standard of care in the future.
REFERENCES 1. Grant GA, McAleer JJ. Incidence of infantile hypertrophic pyloric stenosis. Lancet 1984;1:1177. 2. Ramstedt C. Zur operation der angeborenen pylorus stenose. Med Klin 1912;26:1191-2. 3. Alain JL, Grousseau D, Terrier G. Extramucosal pyloromyotomy by laparoscopy. Surg Endosc 1991;5:174-5. 4. Sola JE, Neville HL. Laparoscopic vs open pyloromyotomy: A systematic review and meta-analysis. J Pediatr Surg 2009;44:1631-7. 5. Hall NJ, Pacilli M, Eaton S, Reblock K, Gaines BA, Pastor A, et al. Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: A double-blind multicentre randomised controlled trial. Lancet 2009;373:390-8. 6. Jain V, Choudhury SR, Chadha R, Puri A, Naga AS. Laparoscopic pyloromyotomy: Is a knife really necessary? World J Pediatr 2012;8:57-60. 7. Oomen MW, Hoekstra LT, Bakx R, Heij HA. Learning curves for pediatric laparoscopy: How many operations are enough? The Amsterdam experience with laparoscopic pyloromyotomy. Surg Endosc 2010;24:1829-33. 8. Hall NJ, Van Der Zee J, Tan HL, Pierro A. Meta-analysis of laparoscopic versus open pyloromyotomy. Ann Surg 2004;240:774-8. 9. Kim SS, Lau ST, Lee SL, Waldhausen JH. The learning curve associated with laparoscopic pyloromyotomy. J Laparoendosc Adv Surg Tech A 2005;15:474-7. 10. van der Bilt JD, Kramer WL, van der Zee DC, Bax NM. Laparoscopic pyloromyotomy for hypertrophic pyloric stenosis: Impact of experience on the results in 182 cases. Surg Endosc 2004;18:907-9. 11. St Peter SD, Holcomb GW 3 rd , Calkins CM, Murphy JP, Andrews WS, Sharp RJ, et al. Open versus laparoscopic pyloromyotomy for pyloric stenosis: A prospective, randomized trial. Ann Surg 2006;244:363-70. 12. Siddiqui S, Heidel RE, Angel CA, Kennedy AP Jr. Pyloromyotomy: Randomized control trial of laparoscopic vs open technique. J Pediatr Surg 2012;47:93-8. 13. Oomen MW, Hoekstra LT, Bakx R, Ubbink DT, Heij HA. Open versus laparoscopic pyloromyotomy for hypertrophic pyloric stenosis: A systematic review and meta-analysis focusing on major complications. Surg Endosc 2012;26:2104-10. 14. Adibe OO, Nichol PF, Flake AW, Mattei P. Comparison of outcomes after laparoscopic and open pyloromyotomy at a high-volume pediatric teaching hospital. J Pediatr Surg 2006;41:1676-8. 15. Leclair MD, Plattner V, Mirallie E, Lejus C, Nguyen JM, Podevin G, et al. Laparoscopic pyloromyotomy for hypertrophic pyloric stenosis: A prospective, randomized controlled trial. J Pediatr Surg 2007;42:692-8. 16. Yagmurlu A, Barnhart DC, Vernon A, Georgeson KE, Harmon CM. Comparison of the incidence of complications in open and laparoscopic pyloromyotomy: A concurrent single institution series. J Pediatr Surg 2004;39:292-6. 17. Leahy PF, Farrell R, O’Donnell B. 300 infants with hypertrophic pyloric stenosis: Presentation and outcome. Ir Med J 1986;79:114-6.
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ABSTRACT Aim: To analyze our experience with laparoscopic pyloromyotomy for infantile hypertrophic pyloric stenosis for the lessons that we learnt and to study the effect of learning curve. Materials and Methods: This is a retrospective analysis of case records of 101 infants who underwent laparoscopic pyloromyotomy over 6 years. The demographic characteristics, conversion rate, operative time, complications, time to first feed and post-operative hospital stay were noted. The above parameters were compared between our early cases (2007-2009) (n = 43) and the later cases (2010-2013) (n = 58). Results: 89 male and 12 female babies ranging in age from 12 days to 4 months (mean: 43.4 days) were operated upon during this period. The babies ranged in weight from 1.8 to 4.7 kg (mean: 3.1 kg). Four cases were converted to open (3.9%): three due to mucosal perforations and one due to technical problem. The mean operative time was 45.7 minutes (49.7 minutes in the first 3 years and 43.0 minutes in the next 3 years). There were 10 complications-4 mucosal perforations, 5 inadequate pyloromyotomies and 1 omental prolapse through a port site. All the complications were effectively handled with minimum morbidity. In the first 3 years of our experience the conversion rate was 9.3%, mucosal perforations were 6.9% and re-do rate was 2.3% as compared to 0%, 1.7% and 6.9%, respectively, in the next 3 years. Mean time for starting feeds was 21.4 hours and mean post-operative hospital stay was 2.4 days. Conclusion: Laparoscopic pyloromyotomy is a safe procedure with minimal morbidity and reasonable operative times. Conversion rates and operative times decrease as experience increases. Our rate of inadequate pyloromyotomy was rather high which we hope to decrease with further experience.
Access this article online Website: www.jiaps.com DOI: 10.4103/0971-9261.142009 Quick Response Code:
KEY WORDS: Infantile hypertrophic pyloric stenosis, laparoscopy, pyloromyotomy
INTRODUCTION Infantile hypertrophic pyloric stenosis (IHPS) is a common condition in infants, affecting approximately 1 to 3 per 1000 live births.[1] Ramstedt’s pyloromyotomy, described in 1912, has remained the gold standard
for treatment of IHPS over the last century.[2] The laparoscopic approach to this procedure was described by Alain et al. in 1991.[3] With advances in the field of minimally invasive surgery in neonates and infants, this approach has gained popularity and a number of centers around the world have reported the safety
Cite this article as: Handu AT, Jadhav V, Deepak J, Aihole JS, G, Narendrababu M, Ramesh S, et al. Laparoscopic pyloromyotomy: Lessons learnt in our first 101 cases. J Indian Assoc Pediatr Surg 2014;19:213-7. Source of Support: Nil, Conflict of Interest: None declared.
Journal of Indian Association of Pediatric Surgeons / Oct-Dec 2014 / Vol 19 / Issue 4
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Handu, et al.: Experience with laparoscopic pyloromyotomy
and feasibility of the procedure. Advantages of the laparoscopic approach have been cited as lesser time to full feeds, lesser analgesic requirement, shorter length of hospital stay and better cosmesis.[4,5] We undertook this study to analyze our experience of performing laparoscopic pyloromyotomy (LP) for IHPS. We also studied the effect of learning curve on operative time, conversion rate and complications. This is the largest reported series in the Indian literature so far.
MATERIALS AND METHODS We retrospectively analyzed the case records of infants who underwent LP for IHPS at our institute between April 2007 to March 2013. Demographic characteristics like age, sex, weight at presentation and duration of symptoms were noted. All patients were diagnosed on clinical grounds and confirmed with ultrasonography (USG). Electrolyte and acid base abnormalities were corrected before surgery.
Operative technique The procedure was the same as that described and practised in the standard literature. The child was given general endotracheal anesthesia. A nasogastric tube was placed to empty the stomach. The infant was placed supine with the surgeon standing at the foot of the table and the monitor placed at the head end. A short 5-mm optical port was inserted through the umbilicus by the open technique for a 20-cm 30-degree 4-mm telescope and one 3-mm right upper quadrant working port was inserted. A percutaneous stitch was taken through the falciform ligament to retract the liver out of the field. A 3-mm stab incision was made in the left subcostal area for direct insertion of the arthrotomy knife and the pyloric spreader. The duodenum was stabilized with a non-traumatic grasper and the arthrotomy knife used to make an incision in the middle of pylorus. The knife was then withdrawn into the arthrotome and the blunt tip was thrust into the pyloric incision and twisted to make adequate space for the pyloric spreader which was then used to gently split the pyloric muscle till the mucosa was seen to be bulging. Care was taken to ensure adequacy of the pyloromyotomy at both gastric and duodenal ends. A satisfactory pyloromyotomy was confirmed by independently moving the two pyloric edges. Air was insufflated through the nasogastric tube to check for any breach of mucosal integrity. Port sites were closed. Feeds were started within the first 24 hours and gradually increased as tolerated by the child. The child was discharged once full feeds were achieved. Seniority of the operating surgeon, operative time, conversion rate, time to first feed, post-op hospital 214
stay and complications were noted from the records. Surgeons were considered senior when they had at least 5 years of experience with laparoscopic surgery. Juniors performing the procedure were assisted by one of the four senior surgeons at all times. We divided our study patients into two groups: Group I: First half (3yrs) of study period; n = 43. Group II: Second half (next 3 yrs) of the study; n = 58. Operative time, conversion rate, complications, time to first feed and hospital stay were compared between the two groups.
Statistical analysis Continuous data was expressed as mean ± standard deviation (SD). Medians were calculated for skewed data. Study patients were divided into two groups as mentioned above. We used SPSS version 17.0, Stata version 13.0 statistical software to find the significance between two groups with respect to various paramneters. Two independent sample t-test and chi-square test were used to compare age and sex variations between the two groups. Operative time, time to first feed and hospital stay between two groups were compared using the Mann-Whitney U test. Complication rates and conversion rates were compared between the two groups using Fisher’s exact test.
RESULTS We performed 101 laparoscopic pyloromyotomies on 89 male (88.1%) and 12 female (11.9%) infants during this period. The mean age of the infants was 43.4 ± 20.2 days (range: 12 days to 4 months) and the mean weight at surgery was 3.1 ± 0.6 kg (range: 1.8 to 4.7 kg). Symptoms ranged in duration from 3 to 45 days (Mean ± SD: 13.1 ± 9.2 days). Sixty-nine cases (68.3%) were performed by senior surgeons and 32 (31.7%) were performed by junior surgeons under supervision. Four cases were converted to open (3.9%)-three due to mucosal perforation and one due to technical problem with insufflation. Mean operative time was 45.7 ± 17.4 minutes (range: 15 to 105 minutes). The longest operative time was in the case of a child who had a mucosal perforation which was sutured laparoscopically with an omental patch and a fresh pyloromyotomy made on the inferior aspect. The operative time reduced from 49.7 minutes to 43.0 minutes in the latter half of our experience. This difference was found to be statistically significant (P value = 0.015). The operative time of the four senior surgeons decreased from 49.2 ± 12.3 minutes (range: 20-75 minutes) to 37.0 ± 17.6 minutes (range: 15-75 minutes).
Journal of Indian Association of Pediatric Surgeons / Oct-Dec 2014 / Vol 19 / Issue 4
Handu, et al.: Experience with laparoscopic pyloromyotomy
Four patients (3.9%) had mucosal perforation of which one was managed successfully laparoscopically while the remaining three were converted to open. Five children (4.9%) had inadequate pyloromyotomy requiring re-do surgery. Two re-do surgeries were performed laparoscopically with a smooth post-operative recovery. Another was attempted laparoscopically but had to be converted to open. Two re-dos were performed by the open technique. The children with inadequate pyloromyotomy presented with persistent vomiting. Two patients had frequent vomiting in the immediate post-operative period and their operative videos were reviewed. It was felt that both these children may have had inadequate pyloromyotomies hence it was decided to re-operate on them. They were operated on the 4th and 5th post-operative day, respectively. Two patients presented about 3 weeks after the first surgery. They had occasional episodes of vomiting starting from the early post-operative period which was initially managed medically. However, as the frequency of vomiting increased they were evaluated with a contrast study which showed a distended stomach with delayed passage of contrast across the pylorus. One patient had a very delayed presentation about 6 weeks after the first surgery. This child underwent a repeat USG and contrast study before being taken up for re-do surgery. One child had omental prolapse through the left subcostal port site on the 2nd post-operative day. One child had self-limiting intra-operative bleeding from the pyloromyotomy site. The child required a postoperative blood transfusion due to significant fall in the hemoglobin but there was no hemodynamic instability or further fall in hemoglobin after the transfusion. USG did not show any collection. The child had an otherwise uneventful postoperative course. There were no wound infections in any patient. Mean time for starting feeds was 21.4 ± 16.2 hours (range: 8 hours-5 days). Few babies had a couple of episodes of emesis on the 1st post-operative day. Mean post-operative hospital stay was 2.4 ± 2.0 days (range: 1-10 days). Reasons for prolonged stay included delayed initiation of feeds in the child with mucosal perforation sutured laparoscopically, sepsis and ileus in two patients and prolonged vomiting in one child. Forty-three laparoscopic pyloromyotomies were performed in the first 3 years of our experience (42.6%) and 58 (57.4%) in the next 3 years. The demographic data between the two groups has been compared in Table 1. Table 2 shows the comparison of outcomes between the two groups. Operative time and conversion rates were
significantly lower in Group II as compared to Group I. However, complication rates did not show any such difference between the groups. In contrast, the rate of inadequate pyloromyotomy was higher in the second half of our study. Time to first feed and duration of hospital stay were not significantly different between the groups.
DISCUSSION Laparoscopic pyloromyotomy (LP) is a technically simple, feasible and safe procedure which is being performed by many centers across the world. Various modifications of the technique have been described in literature. A good alternative in centers where the pyloromyotomy knife and spreader are not available is the technique described by Jain et al.[6] They used the hook electocautery to make the initial pyloric incision and a 3-mm Maryland forceps was used to split the pyloric muscle after incision. We started performing the laparoscopic procedure in 2007, and currently almost all pyloromyotomies are being performed by laparoscopy Table 1: Comparison of demographic data between the two groups Group I (2007-2009) (n = 43) Age (days) 45.3±21.0 (12-90) Mean±SD (Range) Weight (kg) 3.2±0.6 (2-4.5) Mean±SD (Range) Sex (M:F) 36:7 Senior surgeon 39 (90.7%) Junior surgeon 4 (9.3%)
Group II (2010-2013) (n = 58)
P value
42.0±19.6 (15-120)
0.422
3.1±0.6 (1.8-4.7)
0.649
53:5 30 (51.7%) 28 (48.3%)
0.450 —
Table 2: Comparison of outcomes and complications between the two groups Group II (2010-2013)
P value
4(9.3%) 0 (0%) 49.74±12.03 43.02±19.86 (20-75) (15-105) 45.0 40.0 16.88±3.18 22.38±17.77 (12-20) (8-120) 18 18 2±0.94 2.59±2.31 (1-3) (1-10) 2 2 Complications 3(6.9%) 1(1.7%) 1(2.3%) 4(6.9%) 0 1(1.7%) 0 1(1.7%)
0.030*
Group I (2007-2009) Conversion Operative time (min) Mean±SD (Range) Median Time to first feed (hrs) Mean±SD (Range) Median Hospital stay (days) Mean±SD (Range) Median Mucosal perforation Inadequate LP Wound complications Bleeding
0.015*
0.125
0.844 0.309 0.391 0.999 0.999
*P value < 0.05 is significant
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Handu, et al.: Experience with laparoscopic pyloromyotomy
at our centre. Open pyloromyotomies are performed occasionally for the purpose of training of residents. There were no contraindications to performing LP in any of our patients. We analyzed the results of the 101 LP’s performed by us over the last 6 years. We divided our experience into two halves to assess the effect of learning curve. Our overall conversion rate of 3.9% (4/101) was comparable to that reported by other authors.[7-9] Three of these conversions were due to mucosal perforations. We have not had a single conversion in the last 3 years (significant fall from 9.3% to 0%). As our experience grew we were able to significantly decrease the rate of mucosal perforations (6.9% to 1.7%). In fact, the only mucosal perforation we had in the last three years was also managed laparoscopically. Van der Bilt et al. in their study of the impact of experience on LP also showed a fall in mucosal perforation from 8.3% to 0.7% with time.[10] Oomen et al. have also shown a similar fall in mucosal perforation rates with experience.[7] Our operative times were comparable to some studies,[7] but longer than that reported in others.[9,11] There was a decrease in operative times with experience in spite of the fact that more junior surgeons performed the surgeries in the second half. The operative times of the senior surgeons were lower than the overall times and decreased significantly with experience. Van der Bilt et al. have reported no significant difference in mean operative time with time, but operative time per surgeon dropped with experience.[10] Time to full feeds and post-operative length of hospital stay have been studied as markers of post-operative recovery by many authors.[5,11,12] As most children are usually discharged once they tolerate full feeds, time to full feeds and length of hospital stay are usually similar in most patients. Hence, we decided to record time of initiation of feeds, with duration of post operative hospital stay being indicative of time to full feeds. Time to first feed and duration of hospital stay did not significantly change with experience, as is also reported by another study.[9] Oomen et al. have noted that every hospital has different standardized protocols for a feeding regimen, which makes an objective comparison difficult.[13] Five children (4.9%) had inadequate pyloromyotomy requiring re-do surgery. This was comparable to previous reports which have shown a slightly higher rate of incomplete pyloromyotomy after laparoscopy as compared to the open procedure.[4,5,8,10,14-16] However, except for the study by Leclair et al., [15] no other prospective randomized control studies has shown 214
a statistically significant difference in the rate of inadequate pyloromyotomy between the open and laparoscopic methods.[5,11,12] We had a higher rate of inadequate pyloromyotomy in the second half of our study (6.9% vs 2.3%), leading to 4 re-do surgeries for the same. We have not been able to find a suitable justification for this. All these cases had inadequate splitting of the pyloric muscle at the gastric end. These infants had a longer duration of symptoms (21 days vs 12.4 days) as compared to those with adequate pyloromyotomies. In all except one of these cases we observed a marked difficulty in splitting the muscle fibers which we thought was due to the muscles being more fibrotic and difficult to split. However, this was a subjective finding noted by the operating surgeon. It may have been a phenomenon of being overconfident or fear factor (of opening the mucosa). All laparoscopic procedures were recorded and reviewed in order to avoid this complication. Subsequent to this we are making sure that we extend the myotomy adequately proximally. The difference in rates of wound complications and bleeding was not significantly different between the two groups. Initial studies have shown a wound complication rate (dehiscence and infection) as high as 6.7% after OP.[17] Although recent studies have not shown such a high rate of wound complications even with OP, Sola et al. have found that the rate of total complications was significantly lower with LP than OP, due primarily to a lower wound complication rate.[4] We were previously closing only the skin in the 3-mm incisions, however after this incident we have been closing the fascia as well. With experience, we have begun to tackle mucosal perforation and inadequate pyloromyotomies by laparoscopy. This has not been previously reported in the literature. One mucosal perforation and two re-do pyloromyotomies have been successfully completed laparoscopically, both in the latter half of our experience. Our initial cases were performed mostly by senior surgeons who already had advanced laparoscopic skills. Junior surgeons and trainees were also gradually taught the procedure and eventually performed it in comparable times with no additional increase in complications. We feel that LP is a simple procedure which can be easily mastered by trainees. The randomized control trial comparing OP (circumumbilical incision) with LP by Hall et al. had 32 of 87 (37%) laparoscopic procedures done by a trainee under supervision.[5] Comparisons of time to full feed or postoperative length of stay after procedures done by trainees and non-trainees failed to identify any significant difference. The frequency of
Journal of Indian Association of Pediatric Surgeons / Oct-Dec 2014 / Vol 19 / Issue 4
Handu, et al.: Experience with laparoscopic pyloromyotomy
serious complications was similar in patients operated by trainees and non-trainees. In our study, as all junior surgeons were always assisted by a senior surgeon we did not feel it was right to compare the outcomes of junior versus senior surgeons. Although not evaluated in our study, analgesic requirement has been found to be significantly lesser in patients undergoing LP as compared to OP. There is higher parental satisfaction of scars on the visual analog scale showing a definite cosmetic advantage of LP over OP (circumumbilical incision).[5] In fact in the above-mentioned study, a prospective randomized control trial, the trial was halted before full recruitment because of significant treatment benefit in the LP group at interim analysis. They concluded that both OP and LP were safe but LP had advantages over OP, without additional complications or cost implications and recommended it in centers with suitable laparoscopy experience. A more recent meta-analysis of the randomized control trials comparing OP versus LP has found no clear benefit of LP over OP.[13] They have concluded that LP might be acknowledged as the standard of care if the major postoperative complication rate is low and that the choice of procedure depends on discretion of the surgeon. A study by Kim et al. has studied the effect of learning curve and found that LP has a steep learning curve, especially for the first 15 patients. Operative time decreases and becomes more consistent after about 30 cases.[9] Another study by Oomen et al. has found the learning curve in their series to be about 35 cases.[7] We could not arrive at such a number as multiple surgeons including trainees performed the surgeries in our series. Thus, to conclude, laparoscopic pyloromyotomy is a safe procedure which can be performed in pediatric surgical centers with some degree of laparoscopic experience. Operative times are reasonable with a comparable complication rate. The procedure can be easily learnt by junior surgeons and trainees. Although we demonstrated a fall in operative time and conversion rate with experience, our rate of inadequate pyloromyoyomy was rather high. We hope to decrease this with the lessons learnt and further increase in experience. We have also begun to tackle mucosal perforation and inadequate pyloromyotomy laparoscopically.
Laparoscopic pyloromyotomy is yet to be considered the standard of care for management of IHPS, but it is safe, results are comparable with open surgery and gives excellent cosmesis in the long term. As more pediatric centers are adopting this approach, LP is expected to become the standard of care in the future.
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