Robert D. Madoff

Anal fistula surgery: Factors associated with recurrence and incontinence

PURPOSE: This study was undertaken to assess results of surgery for fistula-in-ano and identify risk factors for fistula recurrence and impaired continence. METHODS: We reviewed the records of 624 patients who underwent surgery for fistula-in-ano between 1988 and 1992. Follow-up was by mailed questionnaire, with 375 patients (60 percent) responding. Mean follow-up was 29 months. Fistulas were intersphincteric in 180 patients, transsphincteric in 108, suprasphincteric in 6, extrasphincteric in 6, and unclassified in 75. Procedures included fistulotomy and marsupialization (n=300), seton placement (n=63), endorectal advancement flap (n=3), and other (n=9). Factors associated with recurrence and incontinence were analyzed by univariate and multivariate regression analysis. RESULTS: The fistula recurred in 31 patients (8 percent), and 45 percent complained of some degree of postoperative incontinence. Factors associated with recurrence included complex type of fistula, horseshoe extension, lack of identification or lateral location of the internal fistulous opening, previous fistula surgery, and the surgeon performing the procedure. Incontinence was associated with female sex, high anal fistula, type of surgery, and previous fistula surgery. CONCLUSIONS: Surgical treatment of fistula-in-ano is associated with a significant risk of recurrence and a high risk of impaired continence. Degree of risk varies with identifiable factors.

Is local excision adequate therapy for early rectal cancer

PURPOSE: Radical surgery of rectal cancer is associated with significant morbidity, and some patients with low-lying lesions must accept a permanent colostomy. Several studies have suggested satisfactory tumor control after local excision of early rectal cancer. The purpose of this study was to compare recurrence and survival rates after treating early rectal cancers with local excision and radical surgery. METHODS: One hundred eight patients with T1 and T2 rectal adenocarcinomas treated by transanal excision were compared with 153 patients with T1N0 and T2N0 rectal adenocarcinomas treated with radical surgery. Neither group received adjuvant chemoradiation. Mean follow-up time was 4.4 years after local excision and 4.8 years after radical surgery. RESULTS: The estimated five-year local recurrence rate was 28 percent (18 percent for T1 tumors and 47 percent for T2 tumors) after local excision and 4 percent (none for T1 tumors and 6 percent for T2 tumors) after radical surgery. Overall recurrence was also higher after local excision (21 percent for T1 tumors and 47 percent for T2 tumors) than after radical surgery (9 percent for T1 tumors and 16 percent for T2 tumors). Twenty-four of 27 patients with recurrence after local excision underwent salvage surgery. The estimated five-year overall survival rate was 69 percent after local excision (72 percent for T1 tumors and 65 percent after T2 tumors) and 82 percent after radical surgery (80 percent for T1 tumors and 81 percent for T2 tumors). Differences in survival rate between local excision and radical surgery were statistically significant in patients with T2 tumors. CONCLUSIONS: Local excision of early rectal cancer carries a high risk of local recurrence. Salvage surgery is possible in most patients with local recurrence, but may be effective only in patients with T1 tumors. When compared with radical surgery, local excision may compromise overall survival in patients with T2 rectal cancers.

Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.

IntroductionAlthough Seprafilm® has been demonstrated to reduce adhesion formation, it is not known whether its usage would translate into a reduction in adhesive small-bowel obstruction.MethodsThis was a prospective, randomized, multicenter, multinational, single-blind, controlled study. This report focuses on those patients who underwent intestinal resection (n = 1,701). Before closure of the abdomen, patients were randomized to receive Seprafilm® or no treatment. Seprafilm® was applied to adhesiogenic tissues throughout the abdomen. The incidence and type of bowel obstruction was compared between the two groups. Time to first adhesive small-bowel obstruction was compared during the course of the study by using survival analysis methods. The mean follow-up time for the occurrence of adhesive small-bowel obstruction was 3.5 years.ResultsThere was no difference between the treatment and control group in overall rate of bowel obstruction. The incidence of adhesive small-bowel obstruction requiring reoperation was significantly lower for Seprafilm® patients compared with no-treatment patients: 1.8 vs. 3.4 percent (P < 0.05). This finding represents an absolute reduction in adhesive small-bowel obstruction requiring reoperation of 1.6 percent and a relative reduction of 47 percent. In addition, a stepwise multivariate analysis indicated that the use of Seprafilm® was the only predictive factor for reducing adhesive small-bowel obstruction requiring reoperation. In both groups, 50 percent of first adhesive small-bowel obstruction episodes occurred within 6 months after the initial surgery with nearly 30 percent occurring within the first 30 days. Additionally no first adhesive small-bowel obstruction events were reported in Years 4 and 5 of follow-up.ConclusionsThe overall bowel obstruction rate was unchanged; however, adhesive small-bowel obstruction requiring reoperation was significantly reduced by the use of Seprafilm®, which was the only factor that predicted this outcome.

Accuracy of Endorectal Ultrasonography in Preoperative Staging of Rectal Tumors

PURPOSE: Preoperative staging of rectal tumors is considered essential to tailor treatment for individual patients. The aim of the present study was to evaluate the accuracy of endorectal ultrasonography in preoperative staging of rectal tumors. METHODS: Eleven hundred eighty-four patients with rectal adenocarcinoma or villous adenoma underwent endorectal ultrasonography evaluation at a single institution during a ten-year period. We compared the endorectal ultrasonography staging with the pathology findings based on the surgical specimens in 545 patients who had surgery (307 by transanal excision, 238 by radical proctectomy) without adjuvant preoperative chemoradiation. Comparisons between groups were performed using chi-squared tests and logistic regression analysis. RESULTS: Overall accuracy in assessing the level of rectal wall invasion was 69 percent, with 18 percent of the tumors overstaged and 13 percent understaged. Accuracy depended on the tumor stage and on the ultrasonographer. Overall accuracy in assessing nodal involvement in the 238 patients treated with radical surgery was 64 percent, with 25 percent overstaged and 11 percent understaged. CONCLUSION: The accuracy of endorectal ultrasonography in assessing the depth of tumor invasion, particularly for early cancers, is lower than previously reported. The technique is more precise in distinguishing between benign tumors and invasive cancers and between tumors localized to the rectal wall and tumors with transmural invasion. Differences in image interpretation may in part explain discrepancies in accuracy between studies.

A Pathologic Complete Response to Preoperative Chemoradiation Is Associated With Lower Local Recurrence and Improved Survival in Rectal Cancer Patients Treated by Mesorectal Excision

AbstractPURPOSE: Preoperative chemoradiation reduces tumor size and nodal metastasis in patients with rectal cancer. Tumor downstaging has been associated with an increased probability of a sphincter-saving procedure and with improved local control. However, pathologic complete response to chemoradiation has not been correlated with local control and patient survival. We studied the prognostic value of pathologic complete response to preoperative chemoradiation in rectal cancer patients. METHODS: We have prospectively followed up 168 consecutive patients with ultrasound Stages II (46) and III (122) rectal cancer treated by preoperative chemoradiation followed by radical resection with mesorectal excision; 161 had a curative resection. Recurrence and survival were compared with tumor characteristics and pathologic complete response. Average follow-up was 37 months. RESULTS: Tumor downstaging occurred in 97 (58 percent) patients, including 21 (13 percent) patients who had a pathologic complete response. None of the clinical or pathologic variables was associated with pathologic complete response. The estimated 5-year rate of local recurrence was 5 percent; of distant metastasis, 14 percent. None of the patients with pathologic complete response has developed disease recurrence. We found no difference in survival among patients with pathologic Stages I, II, or III tumors. CONCLUSIONS: A pathologic complete response to preoperative chemoradiation is associated with improved local control and patient survival. For patients without pathologic complete response, the pathology stage does not have prognostic significance.

Local excision of rectal cancer without adjuvant therapy: A word of caution

OBJECTIVE To evaluate the results of local excision alone for the treatment of rectal cancer, applying strict selection criteria. BACKGROUND DATA Several retrospective studies have demonstrated that tumor control in properly selected patients with rectal cancer treated locally is comparable to that observed after radical surgery. Although there is a consensus regarding the need for patient selection for local excision, the specific criteria vary among centers. METHODS The authors reviewed 82 patients with T1 (n = 55) and T2 (n = 27) rectal cancer treated with transanal excision only during a 10-year period. At pathologic examination, all tumors were localized to the rectal wall, had negative excision margins, were well or moderately differentiated, and had no blood or lymphatic vessel invasion, nor a mucinous component. End points were local and distant tumor recurrence and patient survival. RESULTS Ten of the 55 patients with T1 tumors (18%) and 10 of the 27 patients with T2 tumors (37%) had recurrence at 54 months of follow-up. Average time to recurrence was 18 months in both groups. Seventeen of the 20 patients with local recurrence underwent salvage surgery. The survival rate was 98% for patients with T1 tumors and 89% for patients with T2 tumors. Preoperative staging by endorectal ultrasound did not influence local recurrence or tumor-specific survival. CONCLUSION Local excision of early rectal cancer, even in the ideal candidate, is followed by a much higher recurrence rate than previously reported. Although most patients in whom local recurrence develops can be salvaged by radical resection, the long-term outcome remains unknown.

Sacral spinal nerve stimulation for faecal incontinence: multicentre study

BACKGROUND In patients with faecal incontinence in whom conservative treatment fails, options are limited for those with a functionally deficient but morphologically intact sphincter. We investigated the effect of sacral nerve stimulation on continence and quality of life. METHODS In this multicentre prospective trial, 37 patients underwent a test stimulation period, followed by implantation of a neurostimulator for chronic stimulation in 34. Effect on continence was assessed by daily bowel-habit diaries over a 3-week period and on quality of life by the disease-specific American Society of Colon and Rectal Surgeons (ASCRS) questionnaire and the standard short form health survey questionnaire (SF-36). Every patient served as his or her own control. FINDINGS Frequency of incontinent episodes per week fell (mean 16.4 vs 3.1 and 2.0 at 12 and 24 months; p<0.0001) for both urge and passive incontinence during median follow-up of 23.9 months. Mean number of days per week with incontinent episodes also declined (4.5 vs 1.4 and 1.2 at 12 and 24 months, p<0.0001), as did staining (5.6 vs 2.4 at 12 months; p<0.0001) and pad use (5.9 vs 3.7 at 12 months; p<0.0001). Ability to postpone defecation was enhanced (at 12 months, p<0.0001), and ability to completely empty the bowel was slightly raised during follow-up (at 12 months, p=0.4122). Quality of life improved in all four ASCRS scales (p<0.0001) and in seven of eight SF-36 scales, though only social functioning was significantly improved (p=0.0002). INTERPRETATION Sacral nerve stimulation greatly improves continence and quality of life in selected patients with morphologically intact or repaired sphincter complex offering a treatment for patients in whom treatment options are limited.

Faecal incontinence in adults

Faecal incontinence can affect individuals of all ages and in many cases greatly impairs quality of life, but incontinent patients should not accept their debility as either inevitable or untreatable. Education of the general public and of health-care providers alike is important, because most cases are readily treatable. Many cases of mild incontinence respond to simple medical therapy, whereas patients with more advanced incontinence are best cared for after complete physiological assessment. Recent advances in therapy have led to promising results, even for patients with refractory incontinence. Health-care providers must make every effort to communicate fully with incontinent patients and to help restore their self-esteem, eliminate their self-imposed isolation, and allow them to resume an active and productive lifestyle.

Sacral nerve stimulation for fecal incontinence: Results of a 120-patient prospective multicenter study

Background:Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Methods:Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing ≥50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that ≥50% of subjects would achieve therapeutic success, defined as ≥50% reduction of incontinent episodes per week at 12 months compared with baseline. Results:A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2–69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%–90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusion:Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI.

Long-Term Results of Anterior Sphincteroplasty

PURPOSEThis study was designed to evaluate the outcome of anterior sphincteroplasty in a large series with ten-year follow-up.METHODSThe long-term results in 191 consecutive patients who were a median of ten years from sphincteroplasty were assessed. A questionnaire was administered to assess current bowel function, degree of incontinence, and quality of life as measured by the Fecal Incontinence Quality of Life Scale. Subjective assessment of early outcome was available for most patients at a median follow-up of three years.RESULTSDuring the follow-up period, three patients died and one developed severe dementia. Five patients required further surgery for incontinence and were considered failures. Of the remaining 182 patients, 130 (71 percent) returned a completed questionnaire. At ten years follow-up, 6 percent had no incontinence, 16 percent were incontinent of gas only, 19 percent had soiling only, and 57 percent were incontinent of solid stool. Results worsened significantly between the assessments at three and ten years. The only significant predictors of a poor outcome were older age and fecal incontinence at three years. Preoperative anorectal physiology studies did not predict outcome. Scores on the Fecal Incontinence Quality of Life Scale were lower in those with fecal incontinence, indicating a poorer disease-specific quality of life.CONCLUSIONSOnly 40 percent of patients maintain fecal continence long-term after sphincteroplasty. Older patients and patients with poorer short-term function are more likely to have fecal incontinence at ten years. Incontinence at ten years had a negative effect on quality of life. Further research is needed to develop techniques to improve long-term continence in these patients.