Chapter 13
A Practical Guide to Running an Anorectal Laboratory
Joseph T. Gallagher, Sergio W. Larach, and Andrea Ferrara
Introduction
The anorectal laboratory is an invaluable addition to the practice of any coloproctologist, enabling the specialist to provide unique services for patients in a competitive market. The Colon and Rectal Clinic of Orlando is a private practice performing solely colon and rectal surgeries and treat- ments with an anorectal laboratory first established in 1990. Based on the management of this anorectal laboratory, it was our intention to provide a workable model for a community-based private practice physiology center offering such specialist diagnostic and therapeutic services. There are many excellent institutionally based anorectal laboratories around the world;
however, many are not practicable for translation into private colorectal practice.
Goals of an Anorectal Laboratory
The goals in development of an anorectal laboratory are as follows:
1. Provision of a comprehensive assessment of patients referred to the clinic with functional disorders;
2. To provide guidance with both surgical and non-surgical management of such functional disorders, as well as broad and specific management principles that may include changes in lifestyle, diet, toileting details, etc.,
3. To provide actual treatment (and audit), including biofeedback therapies,
4. To coordinate evaluation and treatment as part of a team approach incorporating gastroenterologists, urologists, or urogynecologists as indi- cated. In this respect, even though the coloproctologist directs the evalua- tion of all the patients presenting to the anorectal laboratory, most patients will not undergo surgery.
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Staffing Issues
A successful anorectal laboratory requires a team approach, with person- nel having different areas of expertise. However, there are two key posi- tions required to establish an anorectal laboratory. All patients undergo an initial consultation by a colon and rectal surgeon before they are evaluated by the anorectal laboratory or before starting biofeedback treatment. The coloproctologist will then manage and direct future tests, as well as direct overall care of the patient. It is important in this respect to establish an initial clinical diagnosis of a functional disorder and to ensure that the patient does not have any additional diagnoses that are likely to signifi- cantly impact on the overall success of treatment. Another required par- ticipant for a successful anorectal laboratory is a trained and certified biofeedback therapist who can provide treatment as directed by the surgeon (1,2). Ideally, all of the procedures and staff of the anorectal labo- ratory would be conducted at one site in order to facilitate evaluation and treatment of patients with these disparate functional disorders.
The coloproctologist associated with the lab needs to be knowledgeable about and have an interest in functional disorders; his/her evaluation needs to be comprehensive (American system HCFA level 4 or 5). In addition to a complete physical examination (as extensively discussed in other parts of this book), the patient also should undergo an anoscopy and flexible sig- moidoscopy. Depending on the results of these evaluations, the patients with a functional disorder(s) can effectively be placed into diagnostic and therapeutic algorithms constructed for the unit as described by John Pemberton MD in his book, The Pelvic Floor: Its Function and Disorders (3). We feel it is important to supplement and reinforce this clinical evalu- ation with objective information obtained through the anorectal laboratory, where a similar approach has been offered by Smith (4). The guidelines for the running of an anorectal laboratory such as this may be assisted by data available concerning the management of an ambulatory anorectal service in terms of design, patient referral practice, patient selection, licensure, billing practice, and physician ownership (5).
Here, the surgeon’s role is also one of interpretation of all anorectal phys- iology testing where the allied team performs anal manometry, endorectal ultrasound (ERUS), invasive electromyography (EMG), and pudendal nerve evaluation under direction of the coloproctologist and where the surgeon reviews all imaging studies. Initiation of conservative therapy and additional recommendations including diet, water intake, physical activity, toileting habits, and the like also are made during the initial consultation.
The certified biofeedback therapist will need specific training for pelvic floor dysfunction in order to be able to provide audited biofeedback therapy. This subject is considered in detail in Chapter 6.5. In our lab, the therapist is actually an employee of the clinic. The therapist collects and reviews the patient’s diet diary and will administer the psychological profile
(where necessary) and collate functional scoring tests (including sexual function, constipation, and an incontinence index). The therapist performs the manometry and biofeedback and counsels (and notates) the patient on dietary recommendations and toileting habits.
A radiologist is required for the smooth functioning of the lab—prefer- ably one with a special interest in colorectal functional disorders. In our unit, we have a specialized radiologist from our major institutions who per- forms and interprets the radiologic tests performed for these functional dis- orders. Having such a dedicated radiologist has increased the efficiency and consistency of our radiographic evaluations in complex cases and has stan- dardized algorithms of management where the coordination of findings is completed by the surgeon.
A urogynecologist, urologist, or gynecologist are also becoming impor- tant parts of the anorectal laboratory because about 30% of patients with anorectal functional disorders also have urinary dysfunction and because the vast majority of patients seen are female. Here, sexual function/dys- function is a vital part of the evaluation. These physicians perform their own comprehensive evaluation and also will perform and interpret urodynamic studies where indicated. They also may perform any surgical corrective pro- cedures as indicated for urinary dysfunction and assist in consultation of surgeries where transvaginal surgery may be used.
Ideally, a dietician should be available to counsel and evaluate each patient as part of the team approach, where dietary diaries are a very impor- tant part of the work-up of functional disorders. We currently use the local hospital dieticians as indicated and rely heavily on our biofeedback thera- pist to review these diaries, to reinforce good colonic dietary practices, and to counsel for dietary recommendations. In the best of all worlds, a psy- chologist should be available to evaluate and possibly counsel patients with functional disorders, as these complaints can sometimes be hallmark signs or symptoms of an underlying psychological disorder that should be addressed. Certain patients may be able to make significant improvements with changes in their toileting or dietary habits and with counseling; we are fortunate in our lab because our biofeedback therapist is also a certified mental health counselor, administering a SCL-90-R test for the prediction success with biofeedback therapies (2).
Testing and Equipment
The anorectal laboratory will need to establish it own controls for normal values. Reports generated from the lab will need to be standardized in order to facilitate communication between the team and increase the ability to review the collected information. The equipment used for anal physiology testing is constantly improving and the information collected that each unit has the most experience with tends to be used in clinical practice. Surveys
have shown a shift in the demographics of both manometric and endosono- graphic use throughout both the United Kingdom and the United States (6).
Computerized anorectal manometry uses an eight-channel perfusion catheter with automated catheter withdrawal. This uses a computer program that is windows based (see Chapter 2.3). The standardized infor- mation retrieved from this test includes sphincter pressures at rest and squeeze, mean resting and squeeze sphincter asymmetry, high-pressure zone (HPZ) length, rectal sensation, paradoxical firing during strain, and the balloon rectoanal inhibitory reflex (RAIR). These tests are performed in the office by the therapist under the supervision of a surgeon and show high correlation with conventional manometry in both health and disease (7).
Computerized noninvasive EMG uses an intra-anal or surface sensor.
This test determines the short peaks evaluation, ten-second contraction test, endurance and constipation profile, and is performed during the same visit as the computerized manometry by the biofeedback therapist. Pudendal nerve latency and invasive EMG are performed by the physician in a surgery center or a hospital outpatient neurological center. Invasive EMG is conducted using a single concentric needle electrode placed in the left lateral sphincter complex with the patient in the lithotomy position. The report includes motor unit potential (MUP) evaluation and a graphic eval- uation of pelvic floor dysfunction. Pudendal nerve latency motor latency is determined using a standardized St. Mark’s pudendal electrode glove (see Chapter 2.9).
Anal ultrasound is performed by the physician in the office. The cost of this machine for the office is approximately 22 000 US dollars. It has proven highly sensitive in the detection of internal anal sphincter (IAS) and exter- nal anal sphincter (EAS) defects in patients presenting with fecal inconti- nence and provides a thorough evaluation of all sphincter components in a standardized fashion.
As an allied service, the radiology department should be able, where nec- essary, to perform defecography, colonic transit studies, small bowel series, solid and liquid scintigraphic gastric emptying analyses, and hydrogen breath tests. Guidelines have been internationally established with radiol- ogy departments to ensure a standardization of imaging analysis for func- tional disorders (8). Most of the imaging is performed at a single center dedicated to conducting the imaging in a standard fashion with concise written reports. Having an imaging center familiar with specialized imaging for functional disorders improves the consistency of the results, as well as minimizes patient discomfort.
Biofeedback therapy is performed by the therapist, as has already been discussed. Before each session, the therapist reviews the dietary diary and the patient’s toileting activities since the last visit. The biofeedback sessions will be given in four treatments over a course of up to two months. Patients
may need additional treatments with secondary decay of benefit over time (see Chapter 6.5). Most biofeedback patients use an anal surface electrode and abdominal surface sensors; however, some patients will require an internal anal sensor for optimal results (2). The patient is allowed to sit in their street clothes in front of the monitor and is expected to do therapeu- tic Kegels and advanced Kegels at home. Depending on the patient, they may also receive an anal sensor to be used at home. Clinical improvement is monitored and recorded at each visit.
Additional tests may include comprehensive stool evaluation, where alternative therapies such as probiotics may be prescribed. Further tests and treatments potentially offered by the anorectal laboratory in the future may include radiofrequency anal canal treatments and percutaneous sacral nerve stimulation for fecal incontinence, 24-hour ambulatory anorectal motility studies, and selected pelvic magnetic resonance imaging (MRI). All of these tests and treatments are currently under evaluation and cost analy- sis. As these tests become universally accepted and standardized, they can be added to the armamentarium of the surgeon for the sophisticated treat- ment of patients presenting with functional pelvic disorders (9,10).
A successful anorectal laboratory will require a sound financial business plan. Cost analysis will have to be performed, taking into account state laws, local laws, and regulations. Financial success will have to be determined on an individual basis considering the size of the practice and local reim- bursements for performing the test, interpretation of the test, and the strat- ified compensation for team members. There are many potential benefits that need to be assessed, including predicted increases in the practice patient base and the projected ability to offer services unique to a colon and rectal surgery practice in accordance with agreed surgical and gas- troenterological society standards (11). The bare minimum to start an anorectal laboratory requires a dedicated physician interested in functional disorders and the ability to offer biofeedback therapy. Equipment costs can be prohibitive; the cost can be partially deferred and offset through increas- ing the volume of patients undergoing evaluation by the anorectal labora- tory or possibly through local hospital equipment purchasing strategies.
References
1. Pantankar SK, Ferrara A, Levy JR, Larach SW, Williamson PR, and Perozo S.
Biofeedback in colorectal practice: A multicenter, statewide, three-year experi- ence. Dis Colon Rectum. 1997;40:827–31.
2. Patankar SK, Ferrara A, Larach SW, Williamson PR, Perozo SE, Levy JR, and Mills JA. Electromyographic assessment of biofeedback for fecal incontinence and chronic constipation. Dis Colon Rectum. 1997;40:907–11.
3. Pemberton JH, Swash M, Henry MH, and Lightner DJ. Algorithms. In:
Pemberton JH, Swash M, and Henry MH, editors. The pelvic floor, its function and disorders. Philadelphia: Saunders; 2002. p. 4–10.
4. Smith LE. Practical guide to anorectal testing. 2nd ed. New York: Igaku-Shoin;
1995.
5. Bailey HR and Snyder MJ, editors. Ambulatory anorectal surgery. New York:
Springer Verlag; 2000.
6. Karulf RE, Coller JA, Bartolo DC, Bowden DO, Roberts PL, Murray J, Schoetz DJ Jr, and Veidenheimer MC. Anorectal physiology testing. A survey of avail- ability and use. Dis Colon Rectum. 1991;34:464–8.
7. Zbar AP, Aslam M, Hider A, Toomey P, and Kmiot WA. Comparison of vector volume manometry with conventional manometry in anorectal dysfunction.
Tech Coloproctol. 1998;2:84–90.
8. Diamant NE, Kamm MA, Wald A, and Whitehead WE. A GA technical review on anorectal testing techniques. Gastroenterology. 1999;116:735–60.
9. Speakman CT and Henry MM. The work of an anorectal physiology laboratory.
Baillieres Clin Gastroenterol. 1992;6:59–73.
10. Felt-Bersma RJ, Poen AC, Cuesta MA, and Meuwissen SG. Referral for ano- rectal function evaluation: therapeutic implications and reassurance. Eur J Gastroenterol Hepatol. 1999;11:289–94.
11. Rao SS, Azpiroz F, Diamant N, Enck P, Tougas G, and Wald A. Minimum stan- dards of anorectal manometry. Neurogastroenterol Motil. 2002;14:553–9.
Editorial Commentary
I had the privilege of visiting the Colorectal Unit of Orlando some years ago and found an impressive combination of both specialized equipment and dedicated personnel. There are some guidelines provided in this chapter for the development and running of a successful anorectal labora- tory which follow the recommendations in other units for the construction of an ambulatory proctologic service. I would emphasize some relatively neglected points. Regarding the socioeconomic aspects of the service, the office should be able to effectively deal with insurance companies. Specific request and reporting forms are valuable in the reporting of specialized findings, in the notation for clinical coloproctological conferences concern- ing medical and surgical patient management (and for medicolegal pur- poses) and for the academic collation and presentation of data. I believe that dynamic transperineal ultrasonography should be also available as it is quick and reproducible and is very helpful in the diagnosis of perineal descent, non relaxing puborectalis syndrome, recto-(peritoneo-entero)cele and sigmoidocele. Photographic equipment and video technology is essen- tial for the recording of a database and for teaching purposes and images are necessary to support clinical and research presentations at congresses, workshops, and institutional meetings.
MP
