The study was carried out under the supervision of the Children’s Hospital of Philadelphia IRB and the committee fo the hospital IRB approved the protocols as being compliant with the institutional guidelines. Approval study numbers were assigned as follows: Anoscopy protocol : IRB 19-016573 and Content analysis chart review; IRB 19-016602. 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:
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 score” (CS) was calculated by adding the four (4) quadrant measurements. The function of each patient was listed as either “constipated” defined as fecal retention and/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. 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 by a blinded reviewer.. Bowel function was recorded from the office notes and letters (at least three separate visits) from 1 to 3 years postoperatively. The operative records and the office notes were assessed independently of each other.
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]
To be able to interpret operative reports, the above quotes were used with expanded meanings to be broadly applicable as opposed to verbatum. The documentation of the element being present or absent in the operative note 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. If there was a clear description of the procedure the presence or absence of the element was recorded (yes/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) and at a similar age 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. 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
One of three functional categories was assigned to each patient:
1) Normal bowel Function (NBF) 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 function”. In addition, no complaint of lifestyle or schedule disruption was recorded.. 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
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”.
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 (NBF, constipated, incontinent) was the dependent variable.