Maher A. Abbas

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial

IMPORTANCE Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation. RESULTS Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, -5.3%; 1-sided 95% CI, -10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, -0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, -0.7%; 95% CI, -4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, -4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00726622.

Who is at risk for developing chronic anal fistula or recurrent anal sepsis after initial perianal abscess

PURPOSE: This study was designed to determine factors that contribute to chronic anal fistula or recurrent sepsis after initial perianal abscess. METHODS: A retrospective cohort study was conducted in patients with a first-time perianal abscess who were treated at Kaiser Permanente Los Angeles between 1995 and 2007. Univariate and multivariable analyses were performed with the Cox proportional hazards model to determine predictors of risk for recurrent disease. RESULTS: One hundred and forty-eight patients met inclusion criteria (105 men, 43 women; mean age, 43.6 years). During a mean follow-up of 38 months, the cumulative incidence of chronic anal fistula or recurrent sepsis was 36.5 percent. Univariate and multivariable analyses showed more than two-fold increased risk of recurrence in patients <40 years vs. those ≥40 years (P < 0.01), and univariate analysis showed nondiabetics were 2.69 times as likely to experience recurrence as diabetics (P = 0.04). No significant differences in risk of recurrence were noted for men vs. women (HR = 0.78; P = 0.39), nonsmokers vs. smokers (HR = 1.17; P = 0.58); perioperative antibiotics vs. no antibiotics (HR = 1.51; P = 0.19); or HIV-positive vs. HIV- negative status (HR = 0.72; P = 0.44). CONCLUSIONS: Age younger than 40 years significantly increased risk of chronic anal fistula or recurrent anal sepsis after a first-time episode of perianal abscess. Patients with diabetes may have a decreased risk compared with nondiabetic patients. Gender, smoking history, perioperative antibiotic treatment, and HIV status were not risk factors for chronic anal fistula or recurrent anal sepsis.

Defunctioning loop ileostomy for pelvic anastomoses: predictors of morbidity and nonclosure.

OBJECTIVE: The aim of this study was to determine the morbidity of a defunctioning loop ileostomy and the subsequent closure rate, and to identify the predictors of complications and nonclosure of stoma. DESIGN: This study is a retrospective review of a single-institution experience. PATIENTS: All patients who underwent a planned temporary defunctioning loop ileostomy performed synchronously with a pelvic anastomosis during a 6-year period were included. MAIN OUTCOME MEASURES: The primary outcome measures were the ileostomy complication rate for the entire spectrum of care, readmission and reoperation rates to treat ileostomy complications, and subsequent closure rate. Patient and treatment factors were evaluated for their independent effect on complications and closure rate with the use of multivariable logistic regression. RESULTS: One hundred twenty-three patients were identified (median age, 51 years). Of these patients, 64.2% developed ≥1 minor or major ileostomy complications (13.8% during index hospitalization, 52.8% as outpatient, and 23.4% after closure). Readmitted for dehydration following ileostomy formation were 11.4% of patients. The ileostomy was closed in 76.4% of patients with 8.6% requiring a midline laparotomy. The overall ileostomy-related reoperation rate was 10.4% (2.4% during index hospitalization, 1.6% at readmission, and 6.4% following ileostomy closure). Obesity (BMI ≥30 kg/m2) was associated with a higher overall ileostomy complication rate (OR 8.56, 95% CI 1.64–44.74) and outpatient complication rate (OR 7.69, 95% CI 2.48–23.81). Age >65 years (OR 53.34, 95% CI 4.21–676.14) and hypertension (OR 8.36, 95% CI 1.09–64.43) increased the risks of high ileostomy output and dehydration. Obesity (OR 4.61, 95% CI 1.14–18.54) and smoking (4.47, 95% CI 1.43–13.98) decreased the likelihood of ileostomy closure. LIMITATION: This study was limited by its retrospective nature. CONCLUSIONS: The morbidity of a defunctioning loop ileostomy remains significant. Obesity is an independent predictor of ileostomy complications. Older age and hypertension increase the risks of high-output stoma and dehydration. Almost one quarter of patients never have the ileostomy closed. Obesity and smoking are associated with less likelihood of a subsequent ileostomy closure.

High rate of positive circumferential resection margins following rectal cancer surgery a call to action

Objectives : To identify predictors of positive circumferential resection margin following rectal cancer resection in the United States. Background: Positive circumferential resection margin is associated with a high rate of local recurrence and poor morbidity and mortality for rectal cancer patients. Prior study has shown poor compliance with national rectal cancer guidelines, but whether this finding is reflected in patient outcomes has yet to be shown. Methods: Patients who underwent resection for stage I-III rectal cancer were identified from the 2010–2011 National Cancer Database. The primary outcome was a positive circumferential resection margin. The relationship between patient, hospital, tumor, and treatment-related characteristics was analyzed using bivariate and multivariate analysis. Results: A positive circumferential resection margin was noted in 2859 (17.2%) of the 16,619 patients included. Facility location, clinical T and N stage, histologic type, tumor size, tumor grade, lymphovascular invasion, perineural invasion, type of operation, and operative approach were significant predictors of positive circumferential resection margin on multivariable analysis. Total proctectomy had nearly a 30% increased risk of positive margin compared with partial proctectomy (OR 1.293, 95%CI 1.185–1.411) and a laparoscopic approach had nearly 22% less risk of a positive circumferential resection margin compared with an open approach (OR 0.882, 95%CI 0.790–0.985). Conclusions: Despite advances in surgical technique and multimodality therapy, rates of positive circumferential resection margin remain high in the United States. Several tumor and treatment characteristics were identified as independent risk factors, and advances in rectal cancer care are necessary to approach the outcomes seen in other countries.

Prospective Multicenter Trial Comparing Echodefecography With Defecography in the Assessment of Anorectal Dysfunction in Patients With Obstructed Defecation

BACKGROUND: Defecography is the gold standard for assessing functional anorectal disorders but is limited by the need for a specific radiologic environment, exposure of patients to radiation, and inability to show all anatomic structures involved in defecation. Echodefecography is a 3-dimensional dynamic ultrasound technique developed to overcome these limitations. OBJECTIVE: This study was designed to validate the effectiveness of echodefecography compared with defecography in the assessment of anorectal dysfunctions related to obstructed defecation. DESIGN: Multicenter, prospective observational study. PATIENTS: Women with symptoms of obstructed defecation. SETTING: Six centers for colorectal surgery (3 in Brazil, 1 in Texas, 1 in Florida, and 1 in Venezuela). INTERVENTIONS: Defecography was performed after inserting 150 mL of barium paste in the rectum. Echodefecography was performed with a 2050 endoprobe through 3 automatic scans. MAIN OUTCOME MEASURES: The &kgr; statistic was used to assess agreement between echodefecography and defecography in the evaluation of rectocele, intussusception, anismus, and grade III enterocele. RESULTS: Eighty-six women were evaluated: median Wexner constipation score, 13.4 (range, 6–23); median age, 53.4 (range, 26–77) years. Rectocele was identified with substantial agreement between the 2 methods (defecography, 80 patients; echodefecography, 76 patients; &kgr; = 0.61; 95% CI = 0.48–0.73). The 2 techniques demonstrated identical findings in 6 patients without rectocele, and in 9 patients with grade I, 29 with grade II, and 19 patients with grade III rectoceles. Defecography identified rectal intussusception in 42 patients, with echodefecography identifying 37 of these cases, plus 4 additional cases, yielding substantial agreement (&kgr; = 0.79; 95% CI = 0.57–1.0). Intussusception was associated with rectocele in 28 patients for both methods (&kgr; = 0.62; 95% CI = 0.41–0.83). There was substantial agreement for anismus (&kgr; = 0.61; 95% CI = 0.40–0.81) and for rectocele combined with anismus (&kgr; = 0.61; 95% CI = 0.40–0.82). Agreement for grade III enterocele was classified as almost perfect (&kgr; = 0.87; 95% CI = 0.66–1.0). LIMITATIONS: Echodefecography had limited use in identification of grade I and II enteroceles because of the type of probe used. CONCLUSIONS: Echodefecography may be used to assess patients with obstructed defecation, as it is able to detect the same anorectal dysfunctions found by defecography. It is minimally invasive and well tolerated, avoids exposure to radiation, and clearly demonstrates all the anatomic structures involved in defecation.

Natural orifice transluminal endoscopic surgery: the future of gastrointestinal surgery.

Considering the continued evolution of flexible endoscopy into more of a therapeutic tool and, at the same time, the growing awareness that the degree of invasiveness of surgery has a large impact on patient outcomes, it was perhaps inevitable that endoscopy and surgery would eventually work together (Figure 1). Accelerating technologic developments mean that this theoretic point of fusion has a potential clinical application. It is conceivable that the current generation of surgical endoscopists is on the verge of witnessing a true paradigm shift, which is being referred to as Natural Orifice Transluminal Endoscopic Surgery (NOTES). The potential of flexible endoscopy to perform therapeutic procedures beyond the wall of the gastrointestinal tract was recognized as early as 1980 when the first transluminal feeding gastrostomy was described by Gauderer et al.1 Kozarek et al2 published the first report of successful endoscopic drainage of pseudocyst in 1985. On the surgical side, the established benefits of laparoscopic procedures over conventional laparotomy in terms of patient recovery and perioperative morbidity, the increasing skill set of advanced laparoscopists, and the comfort of practitioners in performing complex surgeries using video imaging and pneumoperitoneum raised the possibility of replicating such operations endoscopically. The first report of oral peritoneoscopy done in animals was published by Kalloo et al3 in 2004. Since then, multiple investigators have used transluminal flexible endoscopy in animal models to perform various intraperitoneal procedures, ranging from tubal ligation to splenectomy3–8 (Table 1). There have been additional reports of clinical cases, but no publications about them have appeared. On the basis of these initial reports exploring both the scope and feasibility of NOTES, the transluminal approach appears to have tremendous potential. However, several important issues, including the safety of this approach and whether it will provide significant patient benefit in terms of postoperative recovery compared with laparoscopy, must be resolved before the new technique is widely introduced into clinical use. Additionally, it is recognized that early use of this approach by surgeons or gastroenterologists who might be relatively inexperienced in the particular skill sets required might lead to serious complications, which should definitely be avoided during the infancy of this concept. To head off such errors and to develop NOTES in a responsible and safe manner, a working group of 14 leading laparoscopic surgeons and endoscopists from the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) and the American Society for Gastrointestinal Endoscopy (ASGE) met in July 2005. The working group was named Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR). The prime goal of the meeting was to produce a document that would serve as a guide for responsible development of NOTES. In the white paper that the group subsequently published, NOSCAR discussed in detail the potential challenges to safe use of NOTES in clinical practice and outlined guidelines for investigators working on NOTES and criteria for expanding participation in NOSCAR.9 Figure 1 Merging of surgery and therapeutic endoscopy Table 1 NOTES procedures described to date Will Natural Orifice Transluminal Endoscopic Surgery Offer Advantages Over Current Surgical Techniques? When the laparoscopic approach was introduced, it was initially argued that it might not provide any benefit to the patient other than better cosmesis. Since then, multiple benefits of laparoscopic surgery, including a decreased neurohumoral stress response,10 decreased immunosuppression,11 less pain, faster recovery,12 and a decreased incidence of wound-related and pulmonary complications, have been recognized.13 In spite of initial skepticism then, today laparoscopy has become a standard approach for most general surgical, gynecologic, and urologic procedures and has been widely accepted for several oncologic procedures as well. NOTES should provide all of the above-mentioned advantages of laparoscopic surgery. In addition, the elimination of all abdominal wall incisions might have several potential benefits. Wound infection is a common surgical complication, with a reported incidence ranging between 2% and 25%, depending on the type of surgery performed.14,15 This has a tremendous adverse impact on patient recovery and health care costs.16 Eliminating all skin incisions would completely eliminate this risk. Incisional hernias and increasing rates of postoperative adhesions are thought to correlate with the size of abdominal wall incision. The incidence of incisional hernia is substantially lower with laparoscopic procedures, where incision size is much smaller than for open surgery, and should be eliminated with NOTES (4%–18% with open surgery17–19 vs 0.2%–3% with laparoscopic surgery20). Similarly, the reported rates of small-bowel obstruction due to adhesions are also significantly lower after laparoscopic surgery compared with open surgery (3.3% vs 7.7%) and will perhaps be further decreased with NOTES.21 Reducing or eliminating these complications would be an important improvement in patient care as well as a major cost savings to society as a whole. Other potential benefits that NOTES has been theorized to offer are decreased postoperative pain, less need for postoperative analgesia, shorter hospital stay, and faster recovery. Additionally, NOTES may have several advantages in specific subpopulations. It may provide an easy alternative access to the peritoneal cavity in morbidly obese patients, in whom traditional open or laparoscopic access can be difficult because of abdominal wall thickness, and could possibly reduce the lifetime risk of incision-related complications in children.22

Predictors of outcome for anal fistula surgery.

OBJECTIVES To review our experience with patients treated for anal fistula secondary to cryptoglandular disease and to determine factors that influence postoperative outcome. DESIGN Retrospective review. SETTING A regional tertiary referral center. PATIENTS Adult patients with anal fistula secondary to cryptoglandular disease. INTERVENTIONS Fistulotomy, advancement flap, and fistula plugging. MAIN OUTCOME MEASURES Rates of operative failure (persistent fistula), incontinence, and septic complications. We evaluated age, sex, previous operation, fistula type, number of fistula tracts, horseshoe fistula, and intervention type to determine their independent influence on outcomes. RESULTS One hundred seventy-nine patients (79.3% male) underwent fistula operation from October 1, 2003, through December 31, 2008. Median age was 45 years. Fistulotomy was undertaken in 82.7% of patients, advancement flap in 10.6%, and plugging in 6.7%. The rates of operative failure, postoperative incontinence, and septic complications were 15.6%, 15.6%, and 7.3%, respectively. Plugging carried the highest failure rate (83.3%) compared with fistulotomy (10.1%) (odds ratio [OR], 44.3 [95% confidence interval (CI), 8.9-221.0; P < .001]) and was the only independent predictor for failure after adjusting for all variables. Being older than 45 years was associated with a higher postoperative incontinence rate compared with the younger group (adjusted OR, 2.8 [95% CI, 1.0-7.7; P = .04]). High transsphincteric and suprasphincteric fistulas were predictors of incontinence compared with subcutaneous fistulas (adjusted OR, 22.9 [95% CI, 2.2-242.0; P = .009] and 61.5 [4.5-844.0; P = .002], respectively). The only predictor of septic complications was plugging compared with fistulotomy (adjusted OR, 15.1 [95% CI, 2.3-97.7; P = .004]). CONCLUSIONS Fistulotomy is the preferred operation for anal fistula. Plugging is associated with the highest operative failure and septic complication rates. Incontinence was influenced more by fistula type and age rather than procedure.

Management of Rectal Injuries Sustained During Laparoscopic Radical Prostatectomy

OBJECTIVES To report on a treatment algorithm for the management of rectal injures. Rectal injuries during laparoscopic radical prostatectomy (LRP) are rare. In the first 200 cases of LRP performed at our institution, 2 (1%) rectal injuries occurred. Our experience prompted collaboration with our colorectal surgery colleagues to develop a treatment algorithm for the management of such injuries. METHODS We report on the management of rectal injuries sustained during LRP at our institution. We describe the intraoperative laparoscopic repair of a rectal tear using a 2-layer interrupted closure with absorbable suture. The conservative, nonoperative, management of a rectourethral fistula in a patient who presented after LRP is also described. Collaboration with our colorectal surgery colleagues resulted in the formulation of a treatment algorithm for intraoperative and postoperative presentations of rectal injury during LRP. The algorithm is presented. RESULTS Of the first 200 cases of LRP at our institution 2 (1%) were complicated by rectal injury. Injuries recognized intraoperatively should be managed laparoscopically if the operating surgeon is adept at intracorporeal suturing. Small rectourethral fistulas can be managed conservatively with urinary catheterization or diversion and antibiotics as needed. Rarely, rectal injuries sustained during LRP will require fecal diversion; injuries that fail to heal despite fecal diversion require operative repair. CONCLUSIONS Rectal injuries incurred during LRP are rare but must be managed successfully to minimize morbidity. Rectal tears recognized intraoperatively can be managed laparoscopically. The development of a rectourethral fistula is a potential complication of LRP. Most fistulas can be managed conservatively with urinary catheterization or diversion. Rarely, rectal injuries that occur during LRP require fecal diversion or definitive operative repair.

Radiofrequency Treatment for Fecal Incontinence: Is It Effective Long-term?

OBJECTIVE: The aim of this study was to evaluate the short- and long-term outcome of the radiofrequency treatment for moderate to severe fecal incontinence. DESIGN: This study is a retrospective review of a single-institution experience. PATIENTS: Patients who underwent the radiofrequency procedure were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the complication rate, short- and long-term response, and the rate of subsequent intervention for incontinence. RESULTS: Twenty-seven patients underwent 31 radiofrequency procedures (81% women; mean age, 64 years). Median length of symptoms was 3 years. Biofeedback had failed for 52% of patients, and 23% of patients had previous surgical intervention. Thirty-eight percent of patients had a sphincter defect. Minor complications were observed in 19% of the patients. A treatment response was noted in 78% of the patients (mean Cleveland Clinic Florida Fecal Incontinence Score: 16 (baseline) and 10.9 (3 months postoperatively)). However, a sustained long-term response without any additional intervention was noted in 22% of the patients, and 52% of the patients underwent or are awaiting additional intervention for persistent or recurrent incontinence (mean follow-up, 40 months). LIMITATION: This study is limited by its retrospective nature and the limited number of subjects. CONCLUSIONS: The radiofrequency procedure was safe, but a long-term benefit was noted in a minority of patients with moderate to severe fecal incontinence. Additional interventions were required in more than half of the patients. Larger studies are needed to determine the impact of various patient-related factors on the outcome of the radiofrequency treatment to identify the ideal patient for this therapy.

Perforation Following Colorectal Endoscopy: What Happens Beyond the Endoscopy Suite?

BACKGROUND The risk factors for perforation from colorectal endoscopy have been well studied, but little is known about clinical outcomes beyond the immediate event. OBJECTIVE To evaluate short- and long-term outcomes of iatrogenic colorectal perforation following colorectal endoscopy. DESIGN Retrospective review over 16 years at a single tertiary care institution. MAIN OUTCOME MEASURES Treatment interventions, morbidity and mortality rates, hospital length of stay, stoma closure rate, and long-term complications. RESULTS Of 132,259 colorectal endoscopies, 26 patients (0.02%) had a perforation (54% males; mean age, 67 years). The rectosigmoid colon was the most common site of perforation (65%). Thirty-eight percent of the perforations were recognized at the time of procedure, 31% presented within 24 hours, and 31% presented beyond 24 hours. Operative repair was undertaken in 85% of the patients, and 15% were managed with inpatient hospital observation. Primary repair was performed in 68% (defunctioning stoma in 18%). Mean hospital length of stay was 10.1 days. The overall postoperative complications rate was 55%, and wound complications were noted in 45%. The 30-day mortality rate was 19%. No death was observed beyond the first month. American Society of Anesthesiologists physical status Classes 3 and 4 were associated with mortality (p = 0.004). Of 7 patients who received a stoma, only 2 patients (29%) had stoma reversal. Long-term complications included incisional hernia (10%) and small-bowel obstruction (5%). CONCLUSIONS Perforation following colorectal endoscopy was uncommon in this study but was associated with significant morbidity and mortality. An increased risk of death was noted with higher American Society of Anesthesiologists physical status class.