Marco E. Allaix

Mortality after bariatric surgery: analysis of 13,871 morbidly obese patients from a national registry.

Objective:To define mortality rates and risk factors of different bariatric procedures and to identify strategies to reduce the surgical risk in patients undergoing bariatric surgery. Summary Background Data:Postoperative mortality is a rare event after bariatric surgery. Therefore, comprehensive data on mortality are lacking in the literature. Methods:A retrospective analysis of a large prospective database was carried out. The Italian Society of Obesity Surgery runs a National Registry on bariatric surgery where all procedures performed by members of the Society should be included prospectively. This Registry represents at present the largest database on bariatric surgery worldwide. Results:Between January 1996 and January 2006, 13,871 bariatric surgical procedures were included: 6122 adjustable silicone gastric bandings (ASGB), 4215 vertical banded gastroplasties (VBG), 1106 gastric bypasses, 1988 biliopancreatic diversions (BPD), 303 biliointestinal bypasses, and 137 various procedures. Sixty day mortality was 0.25%. The type of surgical procedure significantly influenced (P < 0.001) mortality risk: 0.1% ASGB, 0.15% VBG, 0.54% gastric bypasses, 0.8% BPD. Pulmonary embolism represented the most common cause of death (38.2%) and was significantly higher in the BPD group (0.4% vs. 0.07% VBG and 0.03% ASGB). Other causes of mortality were the following: cardiac failure 17.6%, intestinal leak 17.6%, respiratory failure 11.8%, and 1 case each of acute pancreatitis, cerebral ischemia, bleeding gastric ulcer, intestinal ischemia, and internal hernia. Therefore, 29.4% of patients died as a result of a direct technical complication of the procedure. Additional significant risk factors included open surgery (P < 0.001), prolonged operative time (P < 0.05), preoperative hypertension (P < 0.01) or diabetes (P < 0.05), and case load per Center (P < 0.01). Conclusions:Mortality after bariatric surgery is a rare event. It is influenced by different risk factors including type of surgery, open surgery, prolonged operative time, comorbidities, and volume of activity. In defining the best bariatric procedure for each patient the different mortality risks should be taken into account. Choice of the procedure, prevention, early diagnosis, and therapy for cardiovascular complications may reduce postoperative mortality.

Laparoscopic versus open surgery for extraperitoneal rectal cancer: a prospective comparative study.

BackgroundThe role of laparoscopic resection (LR) in the management of extraperitoneal rectal cancer still is unclear. This study aimed to compare perioperative and long-term results of laparoscopic and open resection (OR) for low and midrectal cancer.MethodsA prospective nonrandomized trial comparing patients submitted to OR or LR for low and midrectal cancer at a single institution was conducted.ResultsThe study included 191 consecutive patients: 98 patients who underwent LR and 93 who underwent OR. The mean follow-up period was 46.3 months for LR and 49.7 months for OR. The conversion rate for LR was 18.4%. With the use of LR, the mean time for complete patient mobilization was shorter (1.7 vs 3.3 days; p < 0.001) and patients were earlier in passing flatus (2.6 vs 3.9 days; p < 0.001) and stools (3.8 vs 4.7 days; p < 0.01), and in resuming oral intake (3.4 vs 4.8 days; p < 0.001). The mean hospital stay was shorter for LR, but the difference did not reach significance (11.4 vs 13 days). Morbidity and mortality rates were similar: LR (24.4% and 1%) and OR (23.6% and 2.2%). Laparoscopic patients presented a higher rate of anastomotic fistulas (13.5% vs 5.1%) and reoperations (6.1% vs 3.2%) but the difference was statistically nonsignificant. Laparoscopic resection presented a significantly lower local recurrence rate (3.2% vs 12.6%; p < 0.05). The cumulative survival and disease-free rates at 5 years were, respectively, 80% and 65.4% after LR and 68.9% and 58.9% after OR (nonsignificant difference). Stage-by-stage comparison showed prolonged cumulative survival for stages III and IV cancer in LR (82.5% vs 40.5%; p = 0.006 and 15.8% vs 0%; p = 0.013, respectively) and a reduced rate of cancer-related death for stage III in LR (11.4% vs 51.9%; p = 0.001).ConclusionsAs compared with conventional open surgery, LR for low and midrectal cancer is characterized by a faster recovery and similar overall morbidity (but a higher rate of anastomotic leakages), and does not present any adverse oncologic effect.

Long-term functional results and quality of life after transanal endoscopic microsurgery

Of the few studies that have investigated quality‐of‐life (QoL) outcomes after transanal endoscopic microsurgery (TEM), the majority have reported only short‐term follow‐up data. This study assessed long‐term clinical and instrumental outcomes (QoL, sexual, urinary and sphincter function) after TEM for extraperitoneal rectal cancer.

Transanal endoscopic microsurgery for rectal neoplasms: experience of 300 consecutive cases.

PURPOSE: Abdominal resection for rectal neoplasms is associated with significant morbidity. Local excision with retractors can be proposed only for distal rectal lesions. With this retrospective review of our prospective series of transanal endoscopic microsurgery procedures, we wanted to verify the advantages of local treatment in terms of disease recurrence and complication rates. METHODS: Indications for transanal endoscopic microsurgery were adenoma, early carcinoma, rectal ulcers, carcinoid tumors, gastrointestinal stromal tumors, and leiomyosarcoma apparently located in the extraperitoneal rectum. We analyzed operating time, morbidity and mortality rates, length of hospital stay, staging discrepancy, recurrence rate, and oncological outcome. RESULTS: From January 1993 to January 2007, 300 patients underwent transanal endoscopic microsurgery at our institution. The mean operating time was 66 minutes. The peritoneum was inadvertently opened in 13 cases. The overall morbidity rate was 7.7%. The mean hospital stay was five days. Histology demonstrated cancer in 90 patients. At a mean follow-up of 60 months, the recurrence rate was zero in pT1, 24% in pT2, and 50% in pT3. The overall estimated five-year survival rate was 87%, and the disease-free survival rate was 82%. CONCLUSIONS: Transanal endoscopic microsurgery is safe and effective in the treatment of adenoma and pT1 carcinoma; it carries a lower morbidity than conventional surgery and a recurrence rate comparable to that of conventional surgery.

Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation.

Objective:To evaluate the effect of laparoscopic sleeve gastrectomy (LSG) on gastroesophageal reflux disease (GERD) in morbidly obese patients. Background:Symptomatic GERD is considered by many a contraindication to LSG. However, studies evaluating the relationship between LSG and GERD by 24-hour pH monitoring are lacking. Methods:Consecutive morbidly obese patients selected for LSG were included in a prospective clinical study. Gastroesophageal function was evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry, and 24-hour pH monitoring before and 24 months after LSG. This trial is registered with ClinicalTrials.gov (no. NCT02012894). Results:From June 2009 to September 2011, a total of 71 patients were enrolled into the study; 65 (91.5%) completed the 2-year protocol. On the basis of preoperative 24-hour pH monitoring, patients were divided into group A (pathologic, n = 28) and group B (normal, n = 37). Symptoms improved in group A, with the Gastroesophageal Reflux Disease Symptom Assessment Scale score decreasing from 53.1 ± 10.5 to 13.1 ±3.5 (P < 0.001). The DeMeester score and total acid exposure (% pH <4) decreased in group A patients (DeMeester score from 39.5 ± 16.5 to 10.6 ± 5.8, P < 0.001; % pH <4 from 10.2 ± 3.7 to 4.2 ± 2.6, P < 0.001). Real “de novo” GERD occurred in 5.4% group B patients. No significant changes in lower esophageal sphincter pressure and esophageal peristalsis amplitude were found in both groups. Conclusions:LSG improves symptoms and controls reflux in most morbidly obese patients with preoperative GERD. In obese patients without preoperative evidence of GERD, the occurrence of “de novo” reflux is uncommon. Therefore, LSG should be considered an effective option for the surgical treatment of obese patients with GERD.

Ultrasonic Versus Standard Electric Dissection in Laparoscopic Colorectal Surgery: A Prospective Randomized Clinical Trial

Objective:To assess the safety and efficacy of the ultrasonic dissection (UC) compared with standard electrosurgery (ES) in laparoscopic colorectal surgery. Background Data:High-frequency ultrasound energy was introduced in laparoscopic surgery to improve dissection and coagulation. Very limited data have been published on its use in laparoscopic colorectal surgery. Methods:Patients eligible for elective laparoscopic right or left hemicolectomy (RH and LH), sigmoidectomy (SG), or low anterior resection (LAR) were randomized to either UC or ES. The following data were collected and analyzed: preoperative data (individual patient data, indication for surgery), intraoperative data (conversion to open surgery, conversion ES to UC, operative time, blood loss, complication rate), and postoperative data (morbidity and mortality, volume of drainage, hospital stay). Results:Between January 2002 and December 2003, 171 patients underwent elective laparoscopic colorectal resection. Twenty-5 patients did not satisfy the inclusion criteria and were excluded. The diagnosis of the remaining 146 patients was diverticulitis (44), colonic adenoma (31), adenocarcinoma (70), or epidermoid carcinoma (1). These patients underwent laparoscopic RH (28), LH (31), SG (47), or LAR (40). There were no differences in preoperative data. The overall conversion rate to open surgery was 11.6%, with no differences between the two groups; 20.8% undergoing ES were converted to UC, more frequently during right hemicolectomy or low anterior resection. Operative time, the primary endpoint of this study, did not differ between the two groups: UC 93 minutes versus ES 102.6 minutes (P = 0.46). Intraoperative blood loss was significantly less in UC 140.8 mL versus ES 182.6 mL (P = 0.032). No differences were observed in postoperative morbidity or other preoperative or postoperative parameters. Conclusions:UC is a useful device in laparoscopic colorectal surgery that facilitates completion of difficult cases and reduces intraoperative blood loss. Nevertheless, the majority of laparoscopic procedures can be completed with ES. Therefore, selective use of UC appears to be the most cost-effective policy.

Does Morbid Obesity Change Outcomes after Laparoscopic Surgery for Inflammatory Bowel Disease? Review of 626 Consecutive Cases

BACKGROUND Little is known about the impact of obesity on morbidity in patients with inflammatory bowel disease (IBD) who are undergoing laparoscopic resections. The aim of this study was to evaluate outcomes in a consecutive series of normal weight (NW), overweight (OW), and obese (OB) patients undergoing elective laparoscopic colorectal surgery for IBD. STUDY DESIGN This study is a retrospective analysis of a prospectively collected, Institutional Review Board-approved IBD database. RESULTS Laparoscopic colorectal resection was performed in 626 patients (335 NW, 206 OW, and 85 OB) between August 2002 and December 2011. Operative time and blood loss were significantly higher in the OW and OB groups compared with the NW group (p = 0.001 and p < 0.001). No differences were observed in terms of intraoperative blood transfusions (p = 0.738) or complications (p = 0.196). The OW and OB groups had a significantly higher conversion rate (p = 0.049 and p = 0.037) and a longer incision compared with the NW group (p = 0.002 and p < 0.001). Obesity was an independent predictor of conversion to open surgery. No significant differences between groups were observed in terms of overall 30-day postoperative morbidity (p = 0.294) and mortality (p = 0.796). Long-term complications occurred in 6.3% NW, 7.3% OW, and 4.7% OB patients (p = 0.676). Incisional hernias were more common in the OB group compared with the NW group (p = 0.020). On multivariate analysis, obesity was not an independent risk factor for either early or late postoperative complications. CONCLUSIONS Obesity increases the complexity of laparoscopic resections in IBD with higher blood loss, operative time, and conversion rates, without worsening outcomes.

Electrothermal bipolar vessel sealing system vs. harmonic scalpel in colorectal laparoscopic surgery: a prospective, randomized study.

PURPOSE: This study was designed to compare the efficacy and safety of laparoscopic colorectal surgery performed with the aid of LigaSure® vessel-sealing system or Ultracision®. METHODS: Patients eligible for elective laparoscopic right or left hemicolectomy or anterior resection of rectum were randomly assigned to either the use of Ligasure® or Ultracision®. The primary end point was intraoperative reduction of blood loss. Secondary end points were intraoperative and postoperative morbidity and operative time. RESULTS: Between April 2005 and December 2006, 140 consecutive patients were included in the study (70 Ligasure® and 70 Ultracision®). We performed 31 right hemicolectomies, 69 left hemicolectomies, and 40 anterior resections of rectum. Blood loss was 109.6 ml (Ultracision® 107.9 ml vs. Ligasure® 111.2 ml, P value = 0.72). Intraoperative complication rate was 2.8 percent (Ultracision® 1.4 percent vs. Ligasure® 4.2 percent, P value < 0.01). Postoperative mortality was 0.7 percent. The overall conversion rate was 7.8 percent, 6 in the Ligasure® group and 5 in the Ultracision® group (P value = 0.09). Operative time, considered from pneumoperitoneum to minilaparotomy, was 115.7 minutes (Ultracision® 114.8 minutes vs. Ligasure® 116.3 minutes, P value = 0.89). CONCLUSIONS: Results showed that Ligasure® and Ultracision® are both useful instruments for laparoscopic colorectal surgery with no significant difference in terms of intraoperative/postoperative morbidity and operative time. Choice of which technique to perform should be according to the surgeons preference.

Preoperative infliximab therapy does not increase morbidity and mortality after laparoscopic resection for inflammatory bowel disease.

BACKGROUND: The impact of infliximab on the postoperative course of patients with IBD is under debate. OBJECTIVE: The aim of this study was to evaluate the influence of infliximab on perioperative outcomes in patients undergoing elective laparoscopic resection for IBD. DESIGN: This study is a retrospective analysis of a prospectively collected, institutional review board-approved database. SETTING, PATIENTS, INTERVENTIONS: Patients undergoing laparoscopic resection on preoperative infliximab (infliximab group) were compared with patients who did not receive infliximab (noninfliximab group). MAIN OUTCOME MEASURES: The short-term and long-term morbidity and mortality rates were assessed. RESULTS: Elective laparoscopic resection for IBD was performed on 518 patients from January 2004 through June 2011; 142 patients were treated with infliximab preoperatively. Both groups had similar demographics, type and severity of IBD, comorbidities, and type of surgery. A significantly higher number of patients in the infliximab group had been on aggressive medical therapy to control symptoms of IBD during the month preceding surgery, including steroids (73.9 vs 58.8%, p = 0.002) and immunosuppressors (32.4 vs 20.5%, p = 0.006). Operative time and blood loss were similar (p = 0.50 and p = 0.34). Intraoperative complication rate was 2.1% in both groups. No significant differences were observed in terms of the conversion rate to laparotomy (6.3% vs 9.3%, p = 0.36), overall 30-day postoperative morbidity (p = 0.93), or mortality (p = 0.61). The rates of anastomotic leak (2.1% vs 1.3%, p = 0.81), infections (12% vs 11.2%, p = 0.92), and thrombotic complications (3.5% vs 5.6%, p = 0.46) were similar. Subgroup analyses confirmed similar rates of overall, infectious, and thrombotic complications regardless of whether patients had ulcerative colitis or Crohn’s disease. LIMITATIONS: This study is subject to the limitations of a retrospective design. CONCLUSIONS: Infliximab is not associated with increased rates of postoperative complications after laparoscopic resection.

Results of Neoadjuvant Short-Course Radiation Therapy Followed by Transanal Endoscopic Microsurgery for T1-T2 N0 Extraperitoneal Rectal Cancer

PURPOSE This study was undertaken to assess the short-term outcomes of neoadjuvant short-course radiation therapy (SCRT) followed by transanal endoscopic microsurgery (TEM) for T1-T2 N0 extraperitoneal rectal cancer. Recent studies suggest that neoadjuvant radiation therapy followed by TEM is safe and has results similar to those with abdominal rectal resection for the treatment of extraperitoneal early rectal cancer. METHODS AND MATERIALS We planned a prospective pilot study including 25 consecutive patients with extraperitoneal T1-T2 N0 M0 rectal adenocarcinoma undergoing SCRT followed by TEM 4 to 10 weeks later (SCRT-TEM). Safety, efficacy, and acceptability of this treatment modality were compared with historical groups of patients with similar rectal cancer stage and treated with long-course radiation therapy (LCRT) followed by TEM (LCRT-TEM), TEM alone, or laparoscopic rectal resection with total mesorectal excision (TME) at our institution. RESULTS The study was interrupted after 14 patients underwent SCRT of 25 Gy in 5 fractions followed by TEM. Median time between SCRT and TEM was 7 weeks (range: 4-10 weeks). Although no preoperative complications occurred, rectal suture dehiscence was observed in 7 patients (50%) at 4 weeks follow-up, associated with an enterocutaneous fistula in the sacral area in 2 cases. One patient required a colostomy. Quality of life at 1-month follow-up, according to European Organization for Research and Treatment of Cancer QLQ-C30 survey score, was significantly worse in SCRT-TEM patients than in LCRT-TEM patients (P=.0277) or TEM patients (P=.0004), whereas no differences were observed with TME patients (P=.604). At a median follow-up of 10 months (range: 6-26 months), we observed 1 (7%) local recurrence at 6 months that was treated with abdominoperineal resection. CONCLUSIONS SCRT followed by TEM for T1-T2 N0 rectal cancer is burdened by a high rate of painful dehiscence of the suture line and enterocutaneous fistula, compared to TEM alone and TEM following LCRT, which forced us to stop the study.