The use of "spin" in laparoscopic lower GI surgical trials with nonsignificant results: an assessment of reporting and interpretation of the primary outcomes.

BACKGROUND: Spin has been defined as "specific reporting that could distort the interpretation of results and mislead readers." OBJECTIVE: The purpose of this study was to identify how frequently, and to what extent, "spin" occurs in laparoscopic lower GI surgical trials with nonsignificant results. DATA SOURCES: Publications were referenced in MEDLINE and EMBASE (1992-2012). STUDY SELECTION: Randomized controlled trials comparing laparoscopic with open surgical technique in lower GI surgery were sought. Trials were included if a nonsignificant (p > 0.05) result of the primary outcome(s) occurred. INTERVENTION: The laparoscopic versus open technique in lower GI surgery was studied. MAIN OUTCOME MEASURES: Trials were assessed for frequency, strategy, and extent of "spin," as previously defined. RESULTS: Fifty-eight trials met the inclusion criteria. Sixty-six percent of these trials had evidence of "spin." In general, authors used significant results only (one of multiple primary outcomes, secondary outcomes, or subgroup analyses) (43%) or interpreted nonsignificance as equivalence (43%). Trials with spin were more likely to recommend the laparoscopic approach over the open technique (p < 0.001), were less likely to call for further trials (p = 0.003), and were less likely to acknowledge the nonsignificant differences (p < 0.001). Inadequate randomization was associated with decreased odds of spin (p = 0.03), as was an intent-to-treat analysis (p < 0.0001), whereas inadequate allocation concealment (p = 0.06) was weakly associated with a decrease in spin. No other a priori candidate risk factors were associated with the presence of spin. LIMITATIONS: Funding source was rarely described, so the association between industry funding and spin could not be assessed. CONCLUSION: The distortion of nonsignificant results in laparoscopic trials was highly prevalent in this review. Readers of trials with nonsignificant results should be cautious of the authors' interpretations. Editors, reviewers, and publishers should ensure that author's conclusions correspond to the study's results and design.

Total pelvic exenteration for rectal cancer: outcomes and prognostic factors.

BACKGROUND: To perform complete resection of locally advanced and recurrent rectal carcinoma, total pelvic exenteration (TPE) may be attempted. We identified disease-related outcomes and prognostic factors. METHODS: We conducted a single-centre review of patients who underwent TPE for rectal carcinoma over a 10-year period. RESULTS: We included 28 patients in our study. After a median follow-up of 35 months, 53.6% of patients were alive with no evidence of disease. The 3-year actuarial disease-free and overall survival rates were 52.2% and 75.1%, respectively. On univariate analysis, recurrent disease, preoperative body mass index greater than 30 and lymphatic invasion were poor prognostic factors for disease-free survival, and only lymphatic invasion predicted overall survival. Additionally, multivariate analysis identified lymphatic invasion as an independent poor prognostic factor for disease-free survival in this patient population with locally advanced and recurrent rectal carcinoma. CONCLUSION: Despite the significant morbidity, TPE can provide long-term survival in patients with rectal carcinoma. Additionally, lymphatic invasion on final pathology was an independent prognostic factor for disease-free survival.

Better late than never? Impact of local analgesia timing on postoperative pain in laparoscopic surgery: a systematic review and metaanalysis.

BACKGROUND: This study aimed to determine the effect of local anesthesia administered before laparoscopic surgery (preemptive anesthesia) on postoperative pain. METHODS: The authors searched Medline, EMBase, and the Cochrane Central Register of Controlled Trials, as well as reference lists of textbooks and relevant articles. They contacted experts in the field of anesthesia and laparoscopic surgery for randomized controlled trials comparing preemptive administration of local anesthesia at the incision site or intraperitoneally with postoperative anesthesia administration or placebo. Trials were systematically assessed for eligibility and validity, and data were extracted in duplicate. The data were pooled across studies using a random effects model. RESULTS: The 26 studies that met the inclusion criteria were included in the analysis. Preemptive incisional local anesthetic was superior to placebo in terms of visual analog pain scores (VAS) at 4 h (weighted mean difference [WMD], -9.49 mm; 95% confidence interval [CI], -15.50 to -3.48) and 24 h (WMD, -4.75 mm; 95%CI, -8.90 to 0.60). However, no difference was found between these measures and those for postoperative incision-site infiltration. Preemptive intraperitoneal local anesthetic was superior to placebo in terms of VAS at 4 h (WMD, 5.76 mm; 95%CI, -11.27 to -0.25), 8 h (WMD, -9.64 mm; 95%CI, -13.68 to -5.60), 12 h (WMD, -4.68 mm; 95%CI, -5.86 to -3.49), and 24 h (WMD, -5.57 mm; 95%CI, -8.35 to -2.79), and superior to postoperative anesthesia administration at 8 h (WMD, -7.42; 95%CI, -13.40 to -1.45), 12 h (WMD, -7.27 mm; 95%CI, -10.26 to -4.28), and 24 h (WMD, -7.95 mm; 95%CI, -12.33 to -3.56). CONCLUSION: Preemptive administration of local anesthetic at the incision site reduces postoperative pain compared with placebo but achieves an analgesic effect similar to that of postincisional anesthetic infiltration. Preemptive local anesthetic administered intraperitoneally decreases postoperative pain compared with both placebo and postoperative infiltration. Surgeons should use local analgesia in laparoscopic surgery to decrease postoperative pain, but the timing of administration is significant only for intraperitoneal infiltration.

The more the better?: the impact of surgeon and hospital volume on in-hospital mortality following colorectal resection.

OBJECTIVE: To determine the in-hospital mortality rates for patients undergoing colorectal resection for malignant or benign conditions, and to identify risk factors for in-hospital death, particularly the relationships with surgeon and hospital volume. BACKGROUND: Although there is strong evidence that complex cancer operations are best performed at specialized high-volume centers and by high-volume surgeons, the relationship between surgeon and hospital volume and perioperative outcomes is less well defined for more common procedures such as colorectal resections, particularly for benign diseases. METHODS: We obtained data from the Canadian Institute for Health Information Discharge Abstract Database on all adult patients who underwent colorectal resection between April 1, 2005 and March 31, 2006. We performed a logistic regression to identify variables associated with a higher likelihood of in-hospital death. RESULTS: Twenty-one thousand seventy-four patients underwent colorectal resection, with the majority being elective (59.4%). Malignancy represented the most common indication for resection (56.8%), followed by diverticular disease (16.2%) and inflammatory bowel disease (7.1%). The overall in-hospital mortality rate among patients undergoing colorectal resection was 5.3%. Increased age (adjusted Odds Ratio [OR]: 1.97 per 10 years, P < 0.001), urgent operation (OR: 2.63, P < 0.001), indication for resection (P < 0.001), nature of the surgery (P < 0.001), and several comorbidities were all independently associated with an increased risk of death. Surgeons with higher volumes of colorectal resections achieved significantly lower mortality rates (OR: 0.92 per 20 cases/y, P = 0.003), corresponding to an adjusted mortality rate of 5.6% for surgeons in the bottom decile (1 case per year) compared with 4.5% for surgeons in the top decile (greater than 43 cases per year). Hospital volume was not associated with mortality (OR: 1.00 per 10 cases, P = 0.504). CONCLUSIONS: This large, population-based study suggests that surgeons who perform high volumes of colorectal resections achieve lower in-hospital mortality rates than surgeons with low volumes, whereas the hospital volume does not influence mortality.

CUSUM analysis of J-pouch surgery reflects no learning curve after board certification.

OBJECTIVE: To investigate changes in morbidity and mortality associated with ileal J-pouch surgery performed during the first 3 years of a single surgeon's practice to determine the presence or absence of a learning curve after fellowship training. METHODS: From July 2002 to July 2005, an observational study of postoperative outcomes was undertaken, in which 30-day and inhospital morbidity and mortality were assessed. A total of 37 patients (17 women and 20 men) underwent the surgery; their average age was 32 (range 16-51) years. The operation was performed for ulcerative colitis n = 31), familial adenomatous polyposis n = 4) and indeterminate colitis n = 2); 32 were diverted and 5 were not. Predicted morbidity and mortality were 31.66% and 1.47%, respectively. Observed morbidity and mortality were 29.7% and 0%, respectively. I used a risk-adjusted cumulative sum (CUSUM) model to compare observed outcomes with predicted outcomes according to a validated scoring system and to analyze outcomes with adjusting for risk on a case-by-case basis. RESULTS: CUSUM analysis revealed a flat curve trending down over the duration. CONCLUSION: CUSUM methodology permits documentation of quality control during the first 3 years of practice. The experience of a single board-certified colorectal surgeon reveals acceptable results in the first 3 years of practice, with no obvious learning curve. The results suggest that fellowship training and board certification conferred reasonable proficiency in J-pouch surgery before the onset of practice.

Stapled hemorrhoidopexy is associated with a higher long-term recurrence rate of internal hemorrhoids compared with conventional excisional hemorrhoid surgery.

PURPOSE: The purpose of this systematic review was to compare the long-term results of stapled hemorrhoidopexy with conventional excisional hemorrhoidectomy in patients with internal hemorrhoids. METHODS: A systematic review of all randomized, controlled trials comparing stapled hemorrhoidopexy and conventional hemorrhoidectomy with long-term results was performed by using the Cochrane methodology. The minimum follow-up was six months. Primary outcomes were hemorrhoid recurrence, hemorrhoid symptom recurrence, complications, and pain. RESULTS: Twelve trials were included. Follow-up varied from six months to four years. Conventional hemorrhoidectomy was more effective in preventing long-term recurrence of hemorrhoids (odds ratio (OR), 3.85; 95 percent confidence interval (CI), 1.47-10.07; P < 0.006). Conventional hemorrhoidectomy also prevents hemorrhoids in studies with follow-up of one year or more (OR, 3.6; 95 percent CI, 1.24-10.49; P < 0.02). Conventional hemorrhoidectomy is superior in preventing the symptom of prolapse (OR, 2.96; 95 percent CI, 1.33-6.58; P < 0.008). Conventional hemorrhoidectomy also is more effective at preventing prolapse in studies with follow-up of one year or more (OR, 2.68; 95 percent CI, 0.98-7.34; P < 0.05). Nonsignificant trends in favor of conventional hemorrhoidectomy were seen in the proportion of asymptomatic patients, bleeding, soiling/difficultly with hygiene/incontinence, the presence of perianal skin tags, and the need for further surgery. Nonsignificant trends in favor of stapled hemorrhoidopexy were seen in pain, pruritus ani, and symptoms of anal obstruction/stenosis. CONCLUSIONS: Conventional hemorrhoidectomy is superior to stapled hemorrhoidopexy for prevention of postoperative recurrence of internal hemorrhoids. Fewer patients who received conventional hemorrhoidectomy complained of hemorrhoidal prolapse in long-term follow-up compared with stapled hemorrhoidopexy.

Attainment of continence with J-pouch and artificial bowel sphincter for concomitant imperforate anus and familial adenomatous polyposis: report of a case.

Numerous proven surgical therapies now exist to compensate for loss of anal sphincter function or loss of rectal reservoir capacity. Fecal incontinence that results from the combined loss of rectal reservoir and anal sphincter tone remains a surgical challenge. This case describes what may be the first successful treatment of a patient with imperforate anus and familial adenomatous polyposis using an ileal J-pouch and artificial bowel sphincter.

Surgical management of colon cancer.

The primary mode of therapy for colon cancer continues to be surgery. Although little has changed in the technical aspects of colonic resection, a great deal of research has taken place to develop procedures that enhance staging of disease, optimize postoperative recovery, and improve outcomes in obstructed patients without compromising cancer-related morbidity and mortality. This review explores the current use of laparoscopy, sentinel node biopsy, intraoperative ultrasound, and colonic stents in the elective and emergent management of colon cancer.