Content Analysis Identifies Nuanced Critical Steps in Hirschsprung Disease (HD) Surgery Which Prevent Disabling Incontinence and Improve Outcomes

doi:10.21203/rs.3.rs-1619804/v1

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Content Analysis Identifies Nuanced Critical Steps in Hirschsprung Disease (HD) Surgery Which Prevent Disabling Incontinence and Improve Outcomes

https://doi.org/10.21203/rs.3.rs-1619804/v1

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Purpose: Recently, poor function after Hirschprung’s Surgery has become more common. We hypothesized that accurate construction of the anorectal cuff and inclusion of certain technical elements would correlate with improved long-term function.

Methods:: Anoscopy was performed in dysfunctional patients to measure Anorectal cuff area (CA) reported as the distance from the dentate line to the suture line. Using content analysis, a blinded observer abstracted nine technical elements from operative reports. Function was recorded from 1-3 years post-operative and classified as a) normal bowel function (NBF), b) constipation or c) incontinence. The association the outcomes was determined for each technical element.

Results: CA in 12 incontinent and 8 constipated patients measured 8.75mm² [0-22) and 60.75mm² (32-160) respectively. 92 charts were reviewed resulting in 58 patients. NBF was found in 36 (62%), 11 (20%) had constipation and 11 (20%) had incontinence. 5 elements in the operative reports corelated with NBF. When all 5 were documented, 23/26 (89%) reported NBF while if none were recorded only 3/19 (16 %) had NBF.

Conclusion: Short CA (<22mm²) is associated with incontinence while long CA (>32mm²) is associated with constipation. Procedural components identified by content analysis are key to provide an optimal anorectal cuff preventing incontinence.

Hirschsprung Disease

Content analysis

Surgical Technique

Outcome

Hirschsprung Disease occurs approximately 1 in 5000 births or 26,000 cases a year worldwide. The pathophysiology was first identified by Dr. Orvar Swenson using manometry.[1] He developed a resection and pull-through procedure to remove the nonfunctioning segment of bowel. with a clear technical description of the operation. [2] Good function, defined as 1-3 stools a day without incontinence, was recorded in 89% of patients with no cases of urinary or sexual dysfunction.[3, 4] An appropriately sized anal cuff is required since it still is aganglionic and does not relax. In addition, when the rectum is removed, the colon that is used to replace it does not have the normal defecation dynamic. These characteristics result in an adequate but abnormal defecation mechanism. As this procedure became more widely used and modified, reported long term function was variable with increasing incidence of constipation and incontinence over time. [5] [6] Wyllie reported results similar to those of the innovator and his article is unique in that it painstakingly describes specific technical maneuvers as well. [7] Referring to articles by Drs. Wyllie and Swenson, a review published in 1964 concluded that these critical steps were key to a good outcome. [8] There remained concerns for damage to the pelvic nerves affecting urinary and sexual function, although these complications were never observed. [9] None the less, other techniques were introduced. The Soave pull-through, which uses an endo-rectal mucosectomy reported 88 % good function rate with no urinary or sexual complications when it was introduced.[10, 11] The Duhamel pull-through[12] was designed to allow the procedure to be done at an earlier age and minimize the pelvic dissection while reporting a good functional outcome 82% of the time. Long term problems such as rectal cuff complications in the Soave and fecal retention in the Duhamel reconstruction were also experienced.

Over time, many modifications to the operative technique were introduced. The usefulness of a primary pull through avoiding a colostomy was established.[13, 14] [15] As supportive care of infants advanced the definitive procedure was performed at a younger age, including the neonatal period. [16] [17] Laparoscopy offered new tools in carrying out the reconstruction.[18, 19] [20] Modifications on how to create the anastomosis were also published. [21-23] [24] Outcomes reported for these techniques typically focused on early surgical complications such as entero-colitis, anastomotic leak and stricture of the suture line. [25] Suturing the pull through colon to the skin had also been proposed for safety. [26] When laparoscopic tools were used it has been suggested that the dissection should not be intimate with the rectal wall. [27] A transanal approach to dissection and anastomosis has been recommended as the ideal exposure but required retractors on the anus and relied on limited frozen section preparation to identify the transition zone. [14] Many did well having daily bowel movements and thriving [28-32]. Unlike the early reports, the incidence of constipation and incontinence increased in more recent series ranging from 15-40%. [33-35] Long-term soiling was seen (52%) and constipation (24%) after transanal endorectal pull-through. Using interview data this study documented the incidence higher than most it raising the concern for dysfunctional outcomes. [36] Other sources report incontinence rates of 22%in their series [36]and, in another report, normal bowel function in 66.6% with only 4.9% incontinence.[37] This leads to further development of treatments for incontinence, both surgical and medical.[38]Good results using a Soave pull-through during the same time period was reported by other authors having no fecal incontinence and rare constipation[39]Complications of long-term rectal prolapse were seen if the length of the anal cuff was less than 5 mm above the dentate line [40] Post-operative dysfunction was often associated with specific problems from the procedure such as stricture, sphincter injury and transition zone pull through. [41-46] If the incorrect size of a rectal cuff was created, the functional result was poor but specific optimal cuff size was not determined.[47] More frequently, lifelong care is required for these patients to manage the result.[48]

As these issues are identified, the root cause of these problems remain unclear. It has been reported that that anal cuff and suture line variations may contribute to dysfunction. Objective assessment of anal cuff construction would give insight into this. Although surgical skill has been mentioned [8], assessing certain technical elements used in the procedure offers an opportunity for objectively identifying the cause of constipation and incontinence. It is the hypothesis of this review that a specific sized anal cuff is critical for a good functional outcome and certain technical elements of the operation contribute to achieving this, regardless of the named procedure performed (Swenson, Soave, Duhamel), timing of the operation (neonatal, primary, staged) or technique (laparotomy, laparoscopy, trans-anal). To be able to understand the impact of surgical design on outcome, in this review, the technical elements of the pull through procedure were studied as individual variables using the principle of content analysis. [49] This method identifies words or phrases in a transcription that have significance. Researchers may then quantify and analyze the relationships of such words and phrases. Objectively identifying “content” offers an opportunity to more accurately evaluate a surgical technique recorded rather than just using categories. Reviewing operative notes for content to look towards the ability to extract and code headers has been carried out. [50] Reviewing medical records for identifiable phrases has been applied to the identification of risks for retained surgical items [51] Such analysis can be used to explore textual information to try to identify patterns, the so-called inductive analysis. It can also be used to test the hypothesis when basic information already exists and is being applied to a problem, deductive analysis. [52] Rigorous standards can be used to assure the research is as unbiased as possible. Nonetheless, qualitative data is a continuum and must always be interpreted in the setting of the documents and the goal of the research. [53] In assessing performance, use of resident sensitive quality measure data can contribute to measuring the progress of a physician in training. [54, 55] This project applies these principles to surgical procedures and their outcomes.

The study was carried out under the supervision of the Children’s Hospital of Philadelphia IRB: IRB 19-016573 and IRB 19-016602 and the procedures, including obtaining informed consent, were conducted in accord with the ethical standards of the Committee on Human Experimentation of the institution in which the experiments were done or in accord with the ethical standards of the Helsinki Declaration of 1975.

Anoscopic cuff measurements:

To assess the effect of the size of the anal cuff on dysfunction, anoscopy was performed as part of the clinically indicated evaluation of patients with significant symptoms of incontinence or constipation. The records of the Department of Pediatric General, Thoracic and Fetal Surgery were searched to identify patients undergoing Anoscopy (CPT 46600) with the diagnoses of Hirschsprung disease (ICD 10 Q43.1 or ICD 9 751.3). Records were retrieved from 2007-2019. The operative records were reviewed and the cuff dimensions were extracted from the record. The cuff length was recorded from the crypt of the dentate line when present to the visible suture line (scar and transition to colonic mucosa) in 4 quadrants of the circumference of the anastomosis. The “cuff area” (CA) was calculated by adding the four (4) quadrant measurements and tabulated. The function of each patient was listed as either “constipated” defined as fecal retention or 2 full days without passing stool or “incontinent” defined as requiring a diaper equivalent and/or complaining of frequent stools that cannot be controlled.

Content analysis of operative reports:

To identify the aspects of the pull through procedure which correlate with good outcomes, content analysis was used to study the operative reports.Using the electronic medical record, patients at the Children’s Hospital of Philadelphia from 2007-2018 inclusive that underwent the procedure titled “proctectomy and pull-through” (CPT: 45120) were reviewed. The group represents cases performed by different surgeons, at different points in time, using varied techniques at a variety of ages. Patients were excluded from analysis if there was extensive aganglionosis (transition zone proximal to the sigmoid colon) or there were complicating medical conditions or complications of surgery (leak or stricture). The patient was also excluded if the medical record was inadequate making the operative report difficult to interpret or the outcomes difficult to assess due to incomplete follow up or record keeping. The records were reviewed and data collected blinded to the timing of the surgery (staged or primary), age of the patient, identity of the surgeon or name of the surgical procedure used. To accomplish this, operative reports were printed, redacted and given a study number. Bowel function was recorded from the office notes and letters (at least three separate visits) and given a study number matching the operative report. The operative records and the office notes were assessed independently of each other. The results were then matched by the study number to minimize bias.

Elements for Content Analysis: The following elements (content phrases) quoted from the original description were considered significant. Listed are partial quotes used to identify the element.

1 “…conserve colon..”; 2 “…dissect tissue off rectal wall…” (fig 1); 3 “… dissection continued to the level of internal sphincter…”; 4 “…review proximal margin for ganglia…”; 5 “…evert rectum through anus…” (fig 2); 6 “…dissection complete…” (figure 3-arrow); 7 “…do not separate canal from sphincter…”; 8 “…divide rectum 2-3 cm proximal to mucocutaneous margin…” (fig 3); 9 “…rectum recedes through anus…” (fig 3). [2]

The above quotes are limited in description and might not be applicable when used verbatim. To be able to interpret operative reports from different surgeons using all techniques, the above quotes were given expanded meanings (below) which were used to abstract the records. The documentation of the element being present or abent in the operative record was only recorded if the note was complete and clear. The element was only considered absent if the document clearly stated that it was not performed.

1 conserve colon : a description confirming an effort to preserve as much colon as possible

2 dissect tissue off rectal wall: The intimate pelvic dissection of the entire rectum meaning the dissection and control of bleeding occurred along the muscular wall of the rectum with blood vessel control below the muscle surface (figure 2)

3 dissection continued to the internal sphincter: documentation that the dissection of the aganglionic rectum reached the anal sphincter as evidenced by the intraoperative evaluation of the surgeon.

4 review proximal margin for ganglia: report of the intraoperative pathology confirmation of normal pattern and frequency of ganglion cells at the level of the colon pull through

5 evert rectum through anus : report states that the dissected rectum was prolapsed through the anus and inspected (figure 3) which allowed for an external anastomosis.

6 dissection complete: visualization of the intact mucosa to assure that the dissection was complete and part of the diseased segment was not left behind which would result in a long anal cuff.

7 do not separate canal from sphincter: report identified protection of the internal sphincter fibers and avoided injury to the anoderm or dentate line

8 divide rectum 2-3 cm proximal to mucocutaneous margin : clear description of the creation of an appropriate anal cuff, this could be adjusted for age, size and method of anastomosis but was considered present if the note had a description of a properly placed anastomosis. If the record described a short or missing anal cuff, a low anastomosis or suturing to the anoderm then it was felt to be absent. If there was no documentation detailing the creation of the anastomosis then the subject was excluded

9 rectum recedes through anus colon: the suture line was within the rectum and identified above the dentate line at the desired location.

If the technical element (content phrase) was described in the operative note it was recorded as “yes” for that study number. If there was a clear description of the procedure but the quoted element was missing or the report stated that the element was not performed, it was recorded as “no”. If it appeared that a certain statement was simply missing or the dictation was difficult to understand or incomplete, then that patient was excluded from the study for reason of inadequate record.

Outcomes were compared at a standard interval after the procedure (1-3 years) to avoid the confounding issues of early post-operative dysfunction and the long term accommodation which is seen in most patients.[43, 44] Clinic notes and letters were abstracted and redacted as to the procedure named, surgeon listed and age of the patient. The record was given an identifying number to match the operative report. All notes and records were analyzed by a single reviewer (Doolin). The outcome was only recorded if multiple sources (at least 3 separate encounters including hospital notes, office notes and letters) were consistent in the assessment. If this was not available the patient was excluded from analysis.

One of three functional categories was assigned to define each patient:

1) Normal lifestyle for age: If 1-3 spontaneous bowel movements per day without significant adjuvants such as enemas, irrigations, myomectomy or botulinum toxin were reported the patient was recorded as “normal lifestyle”. In addition, no complaint of lifestyle or schedule disruption was recorded. Use of oral medication such as fiber or laxatives was allowed. In younger patients, the typical use of diapers for up to three stools per day or for urinary function was included here. Occasional temporary dysfunctional episodes secondary to infection or medication were accepted in this category.

2) Constipated: If the notes documented extended days without stool, if there was recorded abdominal distension or if the patient required treatments such as irrigation or Botulinum Toxin injections the result was recorded as “Constipated Function”. Abnormal x-rays including recurrent megacolon was also included. To be placed in this category these symptoms must have been observed consistently for 2 years. This also had an effect on the family’s lifestyle including increased frequency of appointments and procedures.

3) Incontinent: If the office note recorded multiple stools (greater than 3/day with soiling), incontinence, an excessive need for diapers or nocturnal encopresis the result was recorded as “incontinent function”. This category was assigned only if multiple complaints were recorded. Severe contact dermatitis due to constant soiling was considered to be an incontinent patient. The normal use of diapers in the younger age group having fewer than 4 stools a day or needing care for enuresis were not considered problems placing the patient in this group.

Analysis: The paired proportions between the “normal function” and “constipated” or “incontinent” were analyzed using the Chi-Square technique for each individual technical element separately. The presence of the “element” (yes or no) was considered the independent variable. The outcome (normal lifestyle for age, constipated, incontinent) was the dependent variable.

Anoscopy

Twenty-eight patient’s charts were reviewed rendering 29 evaluations (one patient was reevaluated after a redo pull through). Nine (9) were excluded for reasons of post-operative anastomotic complications, and one patient after a Duhamel procedure which does not have a comparable cuff. All of these patients had dysfunctional outcomes which was the clinical indication for the anoscopy. Three (3) patients did not have all four (4) measurements. The missing number was derived from the average of the adjacent numbers. Of the remaining twenty patients, twelve (12) had the complaint of incontinence and eight (8) had constipation. In the incontinent group, the “cuff area”(CA) ranged from 0-22mm². while individual quadrant measurements ranged from 0-12mm. In the constipated group, the “cuff area” ranged from 22–140 mm². while individual measurements ranged from 0–40 mm.

Content analysis: Ninety-two (92) patients’ charts were reviewed. Thirty-four (34) patients were excluded either because of a procedure done for different diagnosis, a significant medical comorbidity, extensive aganglionosis (proximal transition zone), an acute surgical complication (leak, stricture) or inadequate records as described above. Fifty-eight (58) patients made up the study population. The average age of the pull through procedure was 7 months (range 1–36 months). Only 8 of the 58 subjects included were greater than 9 months of age at the time of corrective surgery. Overall, 36 of 58 (62%) of patients had a functionally successful pull through recorded as “normal lifestyle for age”. Of the 22 patients considered unsuccessful 11 were classified as “constipated” requiring mechanical or operative intervention and 11 were classified as “incontinent” with frequent stools and poor control affecting lifestyle.

The outcome of the patients as a function of each of the nine separate elements as an independent variable are listed below and in Table 1. For each element, when present or absent, the number (n) and the percentage (%) of “normal”, “constipated” and “incontinent” children were listed over the total in that category The report below is recorded in the following way:

Table 1

Normal Function: results reported are numbers with normal function/total (percentage) summarizing the 5 elements found to be significant.
Technical Element	Element Present Normal/Total(%)	Element absent Normal/Total(%)	P value
2 dissect off rectal wall	26/31 (83%)	10/27 (37%)	< .01
3 dissection to sphincter	26/32 (81%)	10/26 (38%)	< .01
5 evert rectum	26/30 (87%)	10/28 (36%)	< .01
6 dissection complete	26/31 (84%)	10/27 (37%)	< .01
8 divide 2–3 cm proximal	30/34 (85%)	6/24 (25%)	< .01

Element # “quote“

Present: total n: normal lifestyle for age n (%): Constipated n (%): Incontinent n (%)

Absent: total n: normal lifestyle for age n (%): Constipated n (%): Incontinent n (%)

Element 1: “conserve colon”

This was universally documented in all notes and was not used as an independent variable

Element 2: “dissect tissue off rectal wall”

Present total 31: normal lifestyle for age 26 (83%): Constipated 2/ (6%): Incontinent 3 (10%)

Absent total 27: normal lifestyle for age 10(37%): Constipated 7/ (25%): Incontinent 10 (37%)

Element 3: “dissection continued to the internal sphincter”

Present Total 32: normal lifestyle for age 26 (81%): Constipated 2(6%): Incontinent 4 (12%)

Absent Total 26: normal lifestyle for age 10 (38%): Constipated 7 (27%): Incontinent 9 (35%)

Element 4: “review proximal margin for ganglia”

This was universally documented in all notes and was not used as an independent variable Element 5: “evert rectum through anus”

Present total 30: normal lifestyle for age 26 (87%): Constipated 3 (10%): Incontinent 1 (3%)

Absent total 28: normal lifestyle for age 10 (36%): Constipated 7 (25%): Incontinent 11 (39%)

Element 6: “dissection complete”

Present total 31: normal lifestyle for age 26 (83%): Constipated 2(6%): Incontinent 3 (10%)

Absent total 27: normal lifestyle for age 10 (37%): Constipated 7(26%): Incontinent 10 (37%)

Element 7: “do not separate canal from sphincter”

Wide variations of description made this element difficult to abstract and was therefore excluded from analysis. Element 8: “divide rectum 2–3 cm proximal to mucocutaneous margin”

Present total 34: normal lifestyle for age 30 (88%): Constipated 4 (12%) : Incontinent 0 (0%)

Absent total 24: normal lifestyle for age 6 (25%): Constipated 7 (29%): Incontinent 11 (46%)

Element 9 “rectum recedes through anus colon”

This was universally documented in all notes and could not be analyzed as an independent variable.

Five elements (2,3,5,6,8) demonstrated significant differences in outcome. Two groups were created and compared. Those patients with recording all of the elements studied and those with none of the elements. When all 5 elements were included in the operative note 23/26 (89%) of the patients reported normal lifestyle for age with no reported incontenence while if none of the 5 elements were recorded only 3/19 (16%) had normal lifestyle for age (p < .01).

The anal cuff reconstruction is important for outcome as demonstrated here and reported in other reviews. The hypothesis of this study is that there are critical elements of the pull-through operation contributing to a good result. When comparing treatments by the name of the operation, variations among surgeons and institutions are lost sources of error and inaccuracy.[56–59] When compiling published results using database analysis and publication review, consistent recording methods cannot be assured. In addition, there is a concern that published reports may have skewed.

It was not the purpose of this analysis to declare the best procedure. It has been well established that surgeon experience with any given operation has a significant impact on outcome. In this review the individual elements of the procedure were studied to assess the correlation they had with outcome. Some of the elements could not be studied since they were universally present or absent. Five of the elements, 2 “…dissect tissue off rectal wall…”; 3 “… dissection continued to the level of internal sphincter5 “…evert rectum through anus…”; 6 “…dissection complete…” ; 8 “…divide rectum 2–3 cm proximal to mucocutaneous margin…”; each when present, had a positive correlation with outcome with normal lifestyle for age recorded 81–87% of the time with only one incontinent patient (Table 1). Of the patients in the poorly functioning group, 40% had severe constipation and 60% had incontinence. One element in particular, 9 “divide rectum 2–3 cm proximal to mucocutaneous margin”, had the highest predictability of a patient with a good outcome. (Table 2) This is affirmed by the data of our separate analysis of anoscopic measurement identifying the dimension of the cuff required for good function. The smaller anal cuff led to incontinence and the longer cuff led to constipation. This was stressed in a later review of the various approaches.[60]

Table 2

Detailed analysis of the impact of element 8 on both constipation and incontinence.
Divide 2–3 cm proximal	Element Present	Element Absent	P value
Normal Function	30/34 (88%)	6/24 (25%)	< .01
Constipated	4/34 (12%)	7/24 (29%)	< .01
Incontinent	0/34 (0%)	11/24 (46%)	< .01

A significant number patients have many stools/day in the early post-operative period (less than one year) and most patients ultimately have acceptable function when they are older (greater than 10 years) likely due to bowel accommodation, patient experience and treatment. This makes the length of follow up a significant factor for comparison so children should be compared at similar intervals. The 1–3 year follow up was used as a standard period for comparison. If a patient had “normal lifestyle for age function” they usually require little follow up after three years reducing office visits and treatments. Children with problems require extensive lifelong treatments and care.

Interpreting an operative report to find phrases might be subjective and can also be inconsistent. This is an unmeasurable source of error which must be acknowledged. All records were reviewed by a single individual (Doolin) to try and minimize this. The results of this review also correlate with other reports of dysfunction after pull through where problems can be attributable to scarring, damaged anal cuff or inaccurate histology, all of which may be due to missing one or more elements of the technique.

Hirschsprung pull-through procedures are difficult to evaluate and as the variables increase, comparisons become more challenging with the proliferation of modifications and operations. Content analysis provides a tool that can minimize bias and generalization. This study was carried out to observe the feasibility of assessing certain specific points of the procedure described by Dr. Swenson.[61] Using this, recommendations regarding technique may be offered which can then be incorporated into any approach. This can be a powerful tool when trying to study treatments while recognizing the spectrum of practitioners and settings. By using specific and well-defined parameters, these findings are universally applicable to all procedures and settings.

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No competing interests reported.

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Content Analysis Identifies Nuanced Critical Steps in Hirschsprung Disease (HD) Surgery Which Prevent Disabling Incontinence and Improve Outcomes

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Abstract

Figures

Introduction

Methods

Results

Element # “quote“

Element 1: “conserve colon”

Element 2: “dissect tissue off rectal wall”

Element 3: “dissection continued to the internal sphincter”

Element 4: “review proximal margin for ganglia”

Element 6: “dissection complete”

Element 7: “do not separate canal from sphincter”

Element 9 “rectum recedes through anus colon”

Discussion

Conclusion

References

Additional Declarations

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