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18
K. B. Wilkins and J. R. Notaro
rior sphincter defects from obstetric injury, sphincteroplasty is an option. Patients need to be informed that while good results are usual in the short-term, after 5years, a signicant proportion of patients are back to their base­line function. Repeat sphincteroplasty after a failed repair is typically not recommended unless other options are not feasible. Because of this observed deterioration with time, sacral nerve stimulation has become a rst­line surgical alternative in those with a sphincter defect <180°. Colostomy is again an alternative for those without improvement following other interventions or in those who do not want to pursue other options.

Refer to Algorithm in Fig. 3.3

A. Normal bowel habit can range from three
formed stools per day to one stool every 3days. Denitions of constipation vary but usually include infrequent hard stools that require sig­nicant straining to pass. The Rome IV criteria dene constipation in a patient with 2 or more of the following: less than three bowel move­ments a week, straining with more than 25% of bowel movements, sensation of incomplete evacuation or blockage more than 25% of bowel movements, manual maneuvers to facilitate more than 25% of bowel movements, and lumpy or hard stools in more than 25% of bowel movements. Also, loose stools are rarely present without laxatives and the patient must not meet criteria for IBS. Chronic constipation aficts roughly 15% (range: 2–30%) of the U.S. popu­lation. In 2006, the number of constipation­related medical visits was nearly $6 million USD. Constipation—related health costs are nearly $7 billion a year in the U.S., of which $725,000 USD per year is spent on laxatives.
It is crucial to remember that constipation is a
symptom with many causes. It is not an inde­pendent disease entity. Effective treatment can only be initiated after determining the specic cause. The etiology of constipation can be multifactorial thus posing a diagnostic and therapeutic challenge.
B. and C. After establishing that the patient
meets criteria for constipation by determining the frequency and consistency of the stool, a careful history is obtained. The rst step is to perform a dietary review of ber/roughage/ water intake including a thorough medication review to eliminate antidepressants, anticho­linergics, opiates, antacids (aluminum/cal­cium), calcium channel blockers, sympathomimetics, psychotropic drugs and cholestyramine, as the etiology of constipa­tion. The presence or absence of an urge to defecate can be an invaluable clue to the underlying process. The patient is asked if they frequently delay the call to stool. The patient is queried about the use of enemas in the past and the response to such treatment. No response to enemas may indicate colonic inertia whereas a normal response to an enema may indicate rectal outlet obstruction. Coexisting medical conditions such as Parkinson’s, multiple sclerosis, diabetic auto­nomic neuropathy, spinal cord lesions, cere­bral vascular accidents (CVA)/strokes, scleroderma, and amyloidosis can cause debil­itating constipation. Hypothyroidism and hyperparathyroidism are two common endo­crine abnormalities that cause constipation. Therefore a metabolic workup including thy­roid function tests and parathyroid hormone levels, calcium, magnesium, and phosphorus values, should establish or refute the diagnosis indicated in this scenario.
A focused anorectal exam may provide impor-
tant clues. Rectal exam can assess for impaction, rectocele, rectal prolapse, and baseline subjective function of the pelvic oor (asking the patient to squeeze and push on the examining nger). Anoscopy and rigid sigmoidoscopy will exclude obstruct­ing distal masses and solitary rectal ulcer syndrome. A physical exam can also exclude other causes of irregular bowel function as caused by benign or malignant conditions. Abdominal pain, weight loss, and anemia raise suspicion of a mechanical obstruction and should generally prompt colonoscopy and X-ray/CT scan.
3 Physiologic Testing
19
Fig. 3.3 Algorithm for the initial evaluation and physiologic testing for constipation
D.–H. When constipation is present without
any urge to defecate with poor response to enemas, colonic inertia is suspected. Transit studies are used to provide a measurement of the colonic motor function. Radiographic markers studies including the Sitz marker test, is simple, noninvasive and relatively inexpen­sive. The two most common protocols involve the ingestion of a single gelatinous capsule containing 24 radiopaque rings. One option is to have a single plain lm X-ray on day 5. Alternatively, one may obtain a plain X-ray on days 1, 3, and 5 (possibly 7) if there are still retained markers seen.
The latter method also gives indirect information
regarding gastric emptying and small-bowel motility as well. Additionally, if the majority of markers accumulate in the rectosigmoid by day 3, obstructed defecation is suggested. A disadvantage however is multiple visits to the
X-ray department and increased ionizing radi­ation exposure. Regardless of method, the location and number of markers is recorded. Elimination of greater than 80% of markers is a normal study. If less than 80% of the mark­ers are eliminated and diffusely located throughout the colon, colonic inertia is suspected.
Scintigraphy, following the ingestion of a radio-
labeled meal or charcoal, is performed using a gamma camera imager. This represents a time efcient and accurate means of measuring gastric, small bowel, and colonic transit. It is expensive, and radiation exposure along with limited expertise, pose signicant disadvan­tages. Wireless motility capsule utilizes pH, pressure, and temperature to measure motility. After orally ingesting the capsule, information is transmitted to a portable data receiver worn by the patient. There is nearly a 90%
20
K. B. Wilkins and J. R. Notaro
correlation with radio-opaque marker tests. It is easy to perform, lacks radiation exposure, and provides information on whole gut transit. It is expensive due to a non-reusable capsule. Newer techniques such as high-resolution colonic manometry, and colonic barostat, have been used to directly characterize colonic con­traction patterns and categorize colonic dys­motility. These tend to be available only in specialized digestive disease centers, are expensive and technically very challenging.
Even after colonic inertia is evident on colonic
transit study, certain patients require addi­tional testing including the hydrogen breath test, gastric emptying study/nuclear scintigra­phy, or wireless motility capsule to eliminate dysmotility proximal to the colon. Obviously performing a subtotal colectomy on these patients will not necessarily improve their symptoms. They instead would benet from prokinetic and intestinal pacemaker in select cases. In those patients with isolated colonic inertia, a trial of colonic prokinetic agents is warranted, after maximizing ber and water. Osmotic agents such as lubiprostone and lina­clotide, stimulate intestinal uid secretion by acting on the intestinal chloride channel and guanylate cyclase receptor, respectively. After initial success, then withdrawal from U.S. market, tegaserod, is again available (since
2014) via an emergency treatment investiga­tional new drug protocol through the FDA. Newer agents, such as renzapride, a mixed 5-HT4 receptor agonist and 5-HT3 receptor antagonist, holds promise. If the colonic transit studies are normal and inertia is excluded, continue with ber, water, laxatives, and treatment for IBS-C.
I. Surgical options may be discussed in patients
who are refractory to all dietary and medical management. After exclusion of distal outlet obstruction, subtotal colectomy with ileorec­tal anastomosis can be offered in select patients. Segmental resections are fraught with prohibitive recurrences and subsequent patient dissatisfaction.
J. The act of defecation is a multi-step process
involving many components—ranging from rectal compliance and anal sampling to abdominal Valsalva and sphincter relaxation. The pelvic oor comprised of the levator ani muscles and the endopelvic fascia, plays a crucial role in defecation. Pelvic oor disor­ders and dysfunction can result in various organ prolapses and functional disturbances of the evacuation process; rectal outlet obstruction is one such pelvic oor dysfunction.
Rectal outlet obstruction, also referred to as
obstructed defecation syndrome, is suspected when a constipated patient gets the urge to defecate, but evacuates only partially or not at all. Response to laxatives is a watery loose stool (+/ over ow incontinence) without relief of the rectal pressure. Using an enema can have a successful response but does vary among patients and their specic pathology. The causes of obstructive defecation syn­drome are multiple and varied (Fig.3.4).
Physical exam alone has signicant limitations in
establishing the diagnosis. It may only be helpful with an obvious abnormality such as procidentia or rectoceles. Otherwise the colorectal surgeon must rely on anorectal physiology laboratory testing and imaging to conrm both the diagnosis and the pathology involved.
K. Once clinical suspicion of rectal outlet
obstruction is established, extensive investiga­tion is warranted (Fig.3.2). In order to estab­lish effective medical or surgical treatment, specic anorectal pathology must be identi­ed. The assessment of obstructive defecation syndrome includes both anorectal physiology laboratory testing and X-rays. Anal manome­try will assess resting pressures and rule out hypertonia. The strain maneuver measures the pressure in the high pressure zone while bear­ing down. It should reduce for a few seconds while attempting to defecate. Failure to relax the sphincters is termed anismus or non­relaxing puborectalis. Although the presence
3 Physiologic Testing
Fig. 3.4 Pathology associated with outlet obstruction. Pathologic ndings are separated into those conditions for which surgery may be considered versus those conditions for which biofeedback is indicated
21
of a recto anal inhibitory reex (RAIR) elimi­nates Hirschsprung’s disease, its absence does not necessarily conrm it. However, failure to elicit the RAIR should prompt transanal full thickness rectal biopsies for conrmation. The balloon expulsion test is performed during manometry. The balloon is placed in the rec­tum and inated with 50ml of air or water (or alternatively until the patient has a sensation to defecate). Failure to evacuate the balloon within 1 min suggests outlet obstruction. In normal sized rectums, 200–250cc of balloon ination will elicit an uncomfortably strong urge to defecate is termed the maximum toler­ated volume. Greater volume than this sug­gests mega rectum—a cause or consequence of outlet obstruction. EMG can complement or conrm anal manometric ndings of anis­mus, non-relaxing puborectalis, or paradoxi­cal contraction of the puborectalis.
Once the anorectal physiology laboratory ndings
suggest outlet obstruction, radiographic testing can not only verify the diagnosis but provide specic etiologies and guide treatment plans. Imaging techniques such as ultrasound (endo­vaginal and transperineal), MRI (dynamic pel­vic oor MRI or MR defecography), and cinedefecography (dynamic defecating proc­tography or cystocolpodefecography) have successfully diagnosed pelvic oor disorders.
Cinedefecography, traditionally performed as
dynamic defecating proctography, has long being considered the gold standard for evalu­ating the posterior pelvic compartment. It documents the defecatory process in real­time. By opacifying the bladder, vagina and small-bowel, cystocolpodefecography also detects abnormalities of the anterior and mid­dle pelvic compartments. Distinct advantages are its anatomical position (patient is in a seated position), quick performance timing, and relatively low cost; a considerable dose of ionizing radiation is a distinct disadvantage.
Recently MR defecography or dynamic pelvic
oor MR, has challenged cinedefecography as the new standard. It has multiplanar capabil­ity, excellent soft tissue contrast and ability to evaluate anterior, middle and posterior pelvic compartments. It offers information on both morphology and physiology with this test. Although traditionally the colorectal surgeon concentrates on the posterior pelvic compart­ment for analyzing disorders of defecation, the simultaneous assessment of the anterior and middle compartments may become increasingly benecial to recognize coexisting conditions and reduce recurrences. The lack of ionizing radiation is also an advantage. Proponents, however point out that the obliga­tory supine position does not parallel the usual
22
K. B. Wilkins and J. R. Notaro
physiological position of defecation. An open magnet would address this concern, however, their availability is relatively limited.
Various ultrasound techniques are another
class of emerging technology in the diag­nosis and management of outlet obstruc­tion. Transperineal ultrasound is performed with the patient in dorsal lithotomy position after voiding. Using the ultrasound gel, the probe is placed rmly on the perineum. Both sagittal and coronal views are obtained by rotating the probe. Two-dimensional and 3-dimensional imaging is possible. Additional information is obtained by endo­luminal placement of the probe into the vagina (endovaginal ultrasound). Unlike the transperineal technique, this one requires a full bladder. These ultrasounds are per­formed at rest, on Valsalva and during pelvic oor contraction. Although both can detect a myriad of pathology causing rectal outlet obstruction, a rectocele is best evaluated with a transperineal approach. The place­ment of the probe into the vagina (endovag­inal ultrasound) may reduce/camouage a rectocele. Ultrasound is the least expensive of all the aforementioned techniques. It is often better tolerated than cinedefecography or MRI.Disadvantages include the possible shifting of organ position just by the opera­tor’s placement and compression of the transducer, and the overall limited eld of view compared to the other two techniques.
L. and M. The aforementioned evaluation
should help categorize the patient’s rectal out­let obstruction into mechanical causes (recto­cele, rectal intussusception, procidentia, perineal descent, sigmoidocele and entero­cele) or functional disorders (anismus, non­relaxing or paradoxical puborectalis syndrome). This distinction is crucial since the latter generally is treated conservatively while the former are candidates for surgical intervention if conservative treatment has failed to improve symptoms (Fig.3.4).
The following is a brief summary of the vast
pathological causes of obstructive defecation syndrome and the recommended treatments.
A rectocele is dened as a herniation of the
rectal wall into the posterior vagina, due to an abnormally thin, weak rectovaginal sep­tum. It can be seen in more than 75% of par­ous women and rarely in men. In extreme cases, the posterior vaginal wall may pro­trude beyond the vaginal orice. Symptoms do not necessarily parallel the size of a rec­tocele. Treatment starts with optimizing stool consistency and a trial of biofeedback to maximize pelvic oor relaxation. Surgical repair is reserved if conservative treatment failures. Although rectocele repair can be approached both transvaginally and tran­srectally, the former has shown superiority in select studies.
Rectal intussusception (internal or incomplete
rectal prolapse) has been described in approximately 65% of patients with pelvic oor disorders. It consists of an invagination of the rectal wall that can be located in the anterior or posterior location or circumferen­tially. Procidentia occurs when the intussus­ception protrudes distal to the anal verge. Although early, minor rectal intussusception may not actually obstruct defecation, it may still lead to the debilitating sensation of incomplete evacuation. Solitary rectal ulcer syndrome may be associated with prolapse of all degrees and in extreme cases, rectal pro­lapse can lead to incarceration and strangulation.
Surgical repair of rectal prolapse depends on the
severity of the symptoms. Any review of the literature reveals an exuberant number of sur­gical techniques—mainly because no single procedure addresses all issues. The higher morbidity of abdominal approaches are gener­ally offset/rewarded with lower recurrence rates. Conversely the perineal approaches are fraught with higher recurrences yet reportedly less morbidity and mortality.
3 Physiologic Testing
23
When the small bowel, or sigmoid colon herni-
ates into the Douglas pouch, an enterocele or sigmoidocele, respectively, is formed. They are not always symptomatic, but when indicated, surgical repair is accomplished by obliterating the cul-de-sac.
A generalized weakness of the pelvic oor is
referred to as descending perineal syndrome. It is diagnosed when the anorectal junction descends more than 3 cm below the pubo­coccygeal line. It is caused by the incessant straining associated with obstructive defeca­tion. Pelvic oor weakness and pudendal neu­ropathy from childbirth trauma also contributes. Treatment generally involves bio­feedback for pelvic oor strengthening while also maximizing relaxation during the strain maneuver.
Anismus, non-relaxing puborectalis (NRPR),
and paradoxical puborectalis, comprise a spectrum of pelvic oor dyssynergy. Insufcient, or absence of, puborectalis mus­cle relaxation is the underlying pathology. It has been reported in almost half of constipated patients with outlet obstruction. Treatment, once again is conservative, with biofeedback to maximize pelvic oor relaxation. If a coex­isting mechanical cause of outlet obstruction is present, conservative measures take priority over surgical ones.
If none of the pathology in Fig.3.4 are diagnosed,
continued conservative management is indi­cated. Along with dietary manipulation, opti­mization of stool consistency, empiric trial of prokinetic and biofeedback, psychosocial sup­port can also be helpful.

Suggested Reading

Abdool Z, Sultan AH, Thakar R.Ultrasound imaging of
the anal sphincter complex: a review. Br J Radiol. 2012;85:865–75.
Ahmad AN, Hainsworth A, Williams AB, Schizas
AMP. A review of functional pelvic oor imaging modalities and their effectiveness. Clin Imaging. 2015;39:559–65.
Alavi K, Chan S, Wise P, Kaiser AM, Sudan R, Bordeianou
L.Fecal incontinence: etiology, diagnosis, and man­agement. J Gastrointest Surg. 2015;19:1910–21.
Bordeianou LG, Carmichael JC, Paquette IM, et al.
Consensus statement of denitions for anorectal phys­iology testing and pelvic oor terminology (Revised). Dis Colon Rectum. 2018;61:421–7.
Dietz HP, Beer-Gabel M. Ultrasound in the investiga-
tion of posterior compartment vaginal prolapse and obstructed defecation. Ultrasound Obstet Gynecol. 2012;40:14–27.
Jorge JM, Wexner SD.Etiology and management of fecal
incontinence. Dis Colon Rectum. 1993;36(1):77–97.
Khatri G.Magnetic resonance imaging of pelvic oor dis-
orders. Top Magn Reson Imaging. 2014;23:259–73.
Lalwani N, Moshiri M, Lee JH, Bhargava P, Dighe
M.Magnetic resonance imaging of pelvic oor dys­function. Radiol Clin N Am. 2013;51:1127–39.
Olson CH.Diagnostic testing for fecal incontinence. Clin
Colon Rectal Surg. 2014;27:85–90.
Paquette I, Varma M, Kaiser A, Steele S, Rafferty J.The
American society of colon and rectal surgeons’ clini­cal practice guideline for the treatment of fecal incon­tinence. Dis Colon Rectum. 2015;58:623–36.
Paquette IM, Varma M, Ternent C, et al. The American
Society of Colon and Rectal Surgeons’ Clinical Practice Guideline for the Evaluation and Management of Constipation. Dis Colon Rectum. 2016;59:479–92.
Rezvan A, Jakus-Waldman S, Abbas MA, Yazdany T,
Nguyen J.Review of the diagnosis, management and treatment of fecal incontinence. Female Pelvic Med Reconstr Surg. 2015;21:8–17.
Zbar AP.Posterior pelvic oor disorders and obstructed
defecation syndrome: clinical and therapeutic approach. Abdom Imaging. 2013;38:894–902.
Mechanical Bowel Preparation forElective Colon andRectal Surgery
ChayaShwaartz andOdedZmora
4

Refer to Algorithm in Fig. 4.1

A. The use of mechanical bowel preparation
(MBP) prior to an elective colorectal surgery was the standard of care for many years aim­ing to clear the bowel of fecal matter and to lower the risk of postoperative infectious complications. The initial evidence question­ing the usefulness of mechanical bowel prep­aration has been derived from studies on the management of colorectal trauma. Multiple studies have shown that despite the fact that the colon is unprepared, the mechanism of injury is not as controlled as in elective sur­gery, and there is often a delay between the injury and the repair, primary repair of the colon is safe in the setting of trauma.
B. Postoperative complications such as surgical
site infection (SSI) and anastomotic leak are of major concern both in emergent and elective colorectal surgery. Despite the improvement in surgical techniques, and powerful antibiotics for the control of sepsis, the rate of these complica-
C. Shwaartz Department of Surgery, Sheba Medical Center, Tel Aviv, Israel
O. Zmora (*) Department of Surgery, Shamir Medical Center (Assaf Harofe), Tel Aviv, Israel
Department of Surgery, Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel e-mail: ozmora@post.tau.ac.il
tions is still high, leading to morbidity and mor­tality, prolonged length of stay, and higher cost. SSIs occur in about 15% of colorectal cases. Additionally, the risk for anastomotic leak is reported as between 3% to 20% following colorectal surgery, leading to a signicantly higher mortality rate in these patients.
C. The use of MBP in elective colon and rectal
surgery has been assessed in several single and multicenter randomized controlled trials, which showed that MBP did not decrease the risk for postoperative complications. These results led to decreasing use of MBP.
D. It seems that there is a trend towards decreased
use of bowel preparation (see Algorithm in Fig.4.1). In 2003, a survey including more than 500 surgeons (American Society of Colon and Rectal Surgeons members) showed that 98% of the surgeons participating in the survey used MBP and 75% were using oral antibiotics. A few years later (2006), a multinational survey in Europe and the US showed that 86–97% of patients received bowel preparation. In a recent large multicenter national cohort, about 50% of the patients undergoing elective colectomy received bowel preparation.
E. Recent data generated from several indepen-
dent analysis of large databases show that MBP in combination with oral antibiotics is associ­ated with reduced risk of postoperative SSI and anastomotic leak in patients undergoing elec­tive colorectal surgery.This reduction has not been shown in randomized controlled trials.
© Springer Nature Switzerland AG 2020 S. R. Steele et al. (eds.), Clinical Decision Making in Colorectal Surgery,
https://doi.org/10.1007/978-3-319-65942-8_4
25
26
C. Shwaartz and O. Zmora
Fig. 4.1 Algorithm for mechanical bowel preparation for elective colon and rectal surgery

Single Center Studies

G. Between 2000 and 2007, several larger well
designed single center studies were performed.
F. Brownson etal.were the rst to publish on this
topic in 1992, with their randomized trial of 179 patients to either preparation with polyeth­ylene glycol or no mechanical preparation. This pioneer study was published as a meeting abstract, which was not followed by a full manuscript. Surprisingly, patients who had received preparation experienced a signi­cantly increased rate of anastomotic leak and intra-abdominal infection, compared to patients without preparation. However, there was no signicant difference in the rate of wound infection. This nding was followed by two studies, which were published in the 1990s by Burke etal. and Santos etal.both of which failed to show any signicant difference in the intra-abdominal infection rate. However, wound infection, was more common in patients who had received mechanical prepara­tion in the latter study.
In 2003, the senior author published the largest non-multicenter study published, which included 380 patients undergoing elective colon and rectal surgery with primary anasto­mosis, of whom 193 were randomized to colon and rectal surgery without preoperative mechanical bowel preparation. Importantly, all patients from both groups received oral antibi­otics prior to surgery. Patients undergoing rec­tal surgery were given one phosphate enema on the day of surgery, to avoid extrusion of stool when using a trans- anally inserted sta­pling device. Importantly, patients with tumors smaller than 2cm in diameter were excluded from the study, as palpation of small tumors may be difcult in an unprepared bowel, and these patients may require intra-operative colonoscopy to identify these smaller lesions. Patients who required a diverting stoma proxi­mal to the anastomosis were excluded from the
4 Mechanical Bowel Preparation forElective Colon andRectal Surgery
27
data analysis, thereby reducing the number of low rectal or coloanal anastomoses in this study. The two groups were well matched in parameters of demographic characteristics, indications for surgery and type of surgical procedure. There was no difference in the rate of surgical infectious complications between the two groups. Overall, infectious complica­tion rate was 10.2% in the preparation group, and 8.8% in the non-preparation group. Wound infection, anastomotic leak, and intra­abdominal abscess occurred in 6.4%, 3.7%, and 1.1% in the bowel preparation group ver­sus 5.7%, 2.1%, and 1%, in the no bowel prep­aration group.
H. Ram etal. used the exact same protocol to ran-
domize 329 patients, and found no signicant difference in infectious and overall complica­tion rate between patients who underwent pre­operative mechanical bowel preparation and those who had not, and Miettinen et al. ran­domized 267 patients, in a similar fashion, and found slight and non- signicant increase in anastomotic leak and wound infection rates in patients who had preoperative mechanical bowel preparation. Pena-Soria etal. also pre­sented similar results from a randomized trial including 129 patients that underwent an elec­tive colon or proximal rectal resection with a primary anastomosis by a single surgeon.
I. Several studies suggested that when an ileo-
colonic anastomosis is planned, for instance, in a right, subtotal or total abdominal colec­tomy, surgery can be safely performed with­out mechanical bowel preparation. Advocates of this approach suggest that since the col­umn of stool proximal to the anastomosis, which may mechanically disrupt the anasto­mosis, is avoided in these cases, mechanical cleansing may not be required. We have per­formed a subgroup analysis of our data, including only patients with left- sided anas­tomoses, in order to assess whether this type of anastomosis may be safely performed in the elective setting without mechanical bowel preparation. We included 249 patients with colo-colonic and colo-rectal anastomosis, and showed that the overall infectious com-
plication rate was 12.5% in the preparation group, and 13.2% in the non-preparation group. Wound infection, anastomotic leak, and intra-abdominal abscess were not signi­cantly different among the groups, occurring in 6.6%, 4.2%, and 1.6% in the preparation group, versus 10%, 2.3%, and 0.7% in the non-preparation group. Bucher etal. prospec­tively randomized 153 patients undergoing colon and rectal surgery with left-sided anas­tomosis, and found a signicantly increased complication rate in patients who received mechanical bowel preparation. The overall rate of abdominal infectious complications was 22% in the preparation group and 8% in the non- preparation group, and this differ­ence was statistically signicant. Anastomotic leak occurred in 6% of the preparation group and 1% in the non-preparation group (non­signicant), and mean length of hospital stay was longer for patients who had mechanical bowel preparation (14.9days versus 9.9days).
J. The only single center randomizedstudy sug-
gesting that mechanical bowel preparation given prior to colon and rectal surgery may actually lead to improved outcomes was pub­lished by Platell etal. in 2006. In this study, 335 patients were randomized to receive either oral mechanical bowel preparation using polyethylene glycol, or trans-anal prep­aration using phosphate enema. Patients undergoing any type of elective resection of colon or rectum with anastomosis were eligi­ble for this study, with or without defunction­ing stoma. Although there was no signicant difference in overall anastomotic leak rate between the two groups, there was a signi­cant difference in the severity of the leaks. Six out of seven patients, who developed anastomotic leak following preparation with enema only, required re-operation, as com­pared to none of the three patients who received oral mechanical preparation and leaked. Owing to this difference in re­operation rates, the study was prematurely terminated, before reaching its accrual goal. Three of the patients who required re­operation for anastomotic leak underwent
28
C. Shwaartz and O. Zmora
ultra-low anterior resection, a procedure which was not within the inclusion criteria of most other randomized trials.
K. Single center studies have the advantage of
relative homogeneity of the operative and perioperative techniques, which is an impor­tant factor inuencing the surgical outcome. However, assuming an infectious complica­tion rate of 10%, designing a prospective study which will be able to detect a difference of 5% in the infection rate, in a one tailed sta­tistical test (which only examines if the treat­ment is better than the control, and not the possibility that treatment is actually worse), assuming an alpha level of 0.05, with a statis­tical power of 90%, approximately 770 patients are required to be randomized into each group, for a total of 1540 patients. It is virtually impossible for one institution to acquire such a large number of patients in a reasonable timeframe. Thus, single center studies have the advantage of homogeneity in techniques, but usually lack sufcient power leading to type II error.

Special Considerations

Localization ofSmall Lesions
L. Mechanical bowel preparation may have sev-
eral advantages unrelated to the risk of infec­tion. It facilitates palpation of the entire colon during surgery, and enables the surgeon to perform intra-operative colonoscopy, if required. The intraoperative localization of small tumors may require careful palpation of the colon, which may be more difcult if the colon is loaded with fecal material. Large tumors would usually be easily distinguished from solid feces, but the identication of small tumors may be difcult. In our random­ized controlled trial, we have excluded all patients with tumors smaller than 2 cm in diameter and reported no difculties in tumor localization. Platell et al. did not exclude small tumors leading to difculty inlocaliza-
tion of the tumor in six patients. Thus, we strongly advise selective mechanical bowel preparation in patients with small tumors that have not been marked preoperatively with endoscopic tattoo, to allow for adequate pal­pation and possibly intraoperative endoscopy for tumor localization, if required.
M. In addition, the unprepared bowel does not
allow palpation of the rest of the bowel to exclude synchronous lesions. In the era of modern endoscopy and other imaging tech­niques, the vast majority of patients have high-quality colonic workup prior to surgery, and the necessity of intraoperative palpation is thus limited. In cases where adequate pre­operative full endoscopic colonoscopy or high quality virtual colonoscopy is not possi­ble, mechanical bowel preparation should be considered.
Low Rectal or Coloanal Anastomosis
N. Most randomized controlled trials assessing
the utility of mechanical bowel preparation did not include patients with low rectal or coloanal anastomosis. In our daily practice, most of the patients undergoing coloanal anastomosis concomitantly underwent tempo­rary proximal diversion and were thereby excluded from our study. Interestingly, in the study by Platell and his colleagues, half of the patients who required re-operation for anasto­motic leak underwent ultra-low rectal anasto­mosis with enema preparation only. Additionally, in a propensity score matching analysis by Kim etal., the authors compared the outcomes between patients receiving MBP vs. patients who did not receive bowel prepa­ration. However, patients who underwent left­sided or rectal resection who did not receive MBP had received rectal enemas. In this study, there were signicantly higher rates of severe post-operative complications in these patients compared to patients that received MBP (14% vs. 2%, p=0.03). In a randomized trial, the French GRECCAR III study, it was