Achille Gaspari

Evidence-Based Appraisal of Antireflux Fundoplication

Objective:To highlight the current available evidence in antireflux surgery through a systematic review of randomized controlled trials (RCTs). Summary Background Data:Laparoscopic fundoplication is currently suggested as the gold standard for the surgical treatment of gastroesophageal reflux disease, but many controversies are still open concerning the influence of some technical details on its results. Methods:Papers related to RCTs identified via a systematic literature search were evaluated according to standard criteria. Data regarding the patient sample, study methods, and outcomes were abstracted and summarized across studies. Defined outcomes were examined for 41 papers published from 1974 to 2002 related to 25 RCTs. A meta-analysis was performed pooling the results as odds ratios (OR), rate differences (RD), and number needed to treat (NNT). Data given as mean and/or median values were pooled as a mean ± SD (SD). Results:No perioperative deaths were found in any of the RCTs. Immediate results showed a significantly lower operative morbidity rate (10.3% versus 26.7%, OR 0.33, RD −12%, NNT 8), shorter postoperative stay (3.1 versus 5.2 days, P = 0.03), and shorter sick leave (20.1 versus 35.8 days, P = 0.03) for laparoscopic versus open fundoplication. No significant differences were found regarding the incidence of recurrence, dysphagia, bloating, and reoperation for failure at midterm follow-up. No significant differences in operative morbidity (13.1% versus 9.4%) and in operative time (90.2 versus 84.2 minutes) were found in partial versus total fundoplication. A significantly lower incidence of reoperation for failure (1.6% versus 9.6%, OR 0.21, RD −7%, NNT 14) was found after partial fundoplication, with no significant differences regarding the incidence of recurrence and/or dysphagia. Routine division of short gastric vessels during total fundoplication showed no significant advantages regarding the incidence of postoperative dysphagia and recurrence when compared with no division. The use of ultrasonic scalpel compared with clips or bipolar cautery for the division of short gastric vessels showed no significant effect on operative time, postoperative complications, and costs. Conclusions:Laparoscopic antireflux surgery is at least as safe and as effective as its open counterpart, with reduced morbidity, shortened postoperative stay, and sick leave. Partial fundoplication significantly reduces the risk of reoperations for failure over total fundoplication. Routine versus no division of short gastric vessels showed no significant advantages. A word of caution is needed when implementing these results derived from RCTs performed in specialized centers into everyday clinical practice, where experience and skills may be suboptimal.

Clinical Evaluation of Fibrin Glue in the Prevention of Anastomotic Leak and Internal Hernia after Laparoscopic Gastric Bypass: Preliminary Results of a Prospective, Randomized Multicenter Trial

Background: Gastro-jejunal anastomotic leak and internal hernia can be life-threatening complications of laparoscopic Roux-en-Y gastric bypass (LRYGBP), ranging from 0.1-4.3% and from 0.8-4.5% respectively. The safety and efficacy of a fibrin glue (Tissucol®) was assessed when placed around the anastomoses and over the mesenteric openings for prevention of anastomotic leaks and internal hernias after LRYGBP. Methods: A prospective, randomized, multicenter, clinical trial commenced in January 2004. Patients with BMI 40-59 kg/m2, aged 21-60 years, undergoing LRYGBP, were randomized into: 1) study group (fibrin glue applied on the gastro-jejunal and jejuno-jejunal anastomoses and the mesenteric openings); 2) control group (no fibrin glue, but suture of the mesenteric openings). 322 patients, 161 for each arm, will be enrolled for an estimated period of 24 months. Sex, age, operative time, time to postoperative oral diet and hospital stay, early and late complications rates are evaluated. An interim evaluation was conducted after 15 months. Results: To April 2005, 204 patients were randomized: 111 in the control group (mean age 39.0±11.6 years, BMI 46.4±8.2) and 93 in the fibrin glue group (mean age 42.9±11.7 years, BMI 46.9±6.4). There was no mortality or conversion in both groups; no differences in operative time and postoperative hospital stay were recorded. Time to postoperative oral diet was shorter for the fibrin glue group (P=0.0044). Neither leaks nor internal hernias have occurred in the fibrin glue group. The incidence of leaks (2 cases, 1.8%) and the overall reoperation rate were higher in the control group (P=0.0165). Conclusion: The preliminary results suggest that Tissucol® application has no adverse effects, is not time-consuming, and may be effective in preventing leaks and internal hernias in morbidly obese patients undergoing LRYGBP.

Bacterial translocation and intestinal morphological findings in jaundiced rats

The susceptibility to sepsis in obstructive jaundice may be related to bacterial translocation (BT) from the gastrointestinal tract. We evaluated BT to visceral organs and morphological changes of the intestinal mucosa in a rat model of obstructive jaundice. Animals were randomly divided into two groups: in group A the common bile duct was tied and divided, while group B had the bile duct mobilized but not tied. After seven days, peritoneal swabs and liver, spleen, pancreas, lung, mesenteric lymph nodes (MLN), cecum, and terminal ileum biopsies were obtained for cultures. Light and electron microscopy were performed on intestinal samples. The TUNEL assay was performed to detect apoptosis. Data were analyzed using Fisher exact test and Student ttest. Bile duct obliteration resulted in an increased incidence of BT. Seven days after duct obliteration, BT to the peritoneal cavity was evident in 37.5% of the animals in group A and 25% in group B. The respective BT rates for the two groups were: 42.8% vs 37.5% to MLN, 71.4% vs 25% to liver, 42.8% vs 12.5% to spleen, 28.6% vs 0% to pancreas and 14.3% vs 0% to lungs. Despite a trend, this was not statistically significant. Cecal counts did not differ statistically among the groups, while ileal counts were significantly higher in jaundiced rats (P < 0.05). Structural and ultrastructural abnormalities were evident only in the mucosa of the terminal ileum of jaundiced rats. Apoptosis was significantly increased in the terminal ileum of jaundiced rats (P < 0.002). This study suggests the possible association of biliary obstruction and BT. The nonspecific physical injury observed may contribute to breakdown of gastrointestinal barrier function thus promoting BT.

Laparoscopic single-port sleeve gastrectomy for morbid obesity: preliminary series.

BACKGROUND Laparoscopic sleeve gastrectomy has been recently proposed as a sole bariatric procedure because of the resulting considerable weight loss in morbidly obese patients. Traditionally, laparoscopic sleeve gastrectomy requires 5-6 skin incisions to allow for placement of multiple trocars. With the introduction of single-incision laparoscopic surgery, multiple abdominal procedures have been performed using a sole umbilical incision, with good cosmetic outcomes. The purpose of our study was to evaluate the feasibility and safety of laparoscopic single incision sleeve gastrectomy for morbid obesity. METHODS A total of 8 consecutive patients underwent laparoscopic single-incision sleeve gastrectomy at the Operative Unit of Bariatric Surgery of the University of Rome Tor Vergata from March 2009 to June 2009. RESULTS Of the 8 patients, 5 were women and 3 were men, with a mean age of 44.4 years. The mean preoperative body mass index was 56.2 kg/m(2). The mean operative time was 128 minutes. The mean postoperative stay was 2.4 days. The mean postoperative body mass index was 49.3 kg/m(2) at a mean follow-up period of 3.6 months. The mean percentage of excess weight loss was 33% for the same period. CONCLUSIONS Laparoscopic single-incision sleeve gastrectomy seems to be safe, technically feasible, and reproducible. A randomized trial comparing single-incision sleeve gastrectomy and conventional sleeve gastrectomy might be needed to evaluate the postoperative results in relation to the development of abdominal wall complications.

Percutaneous Liver Biopsy Using an Ultrasound-Guided Subcostal Route

Percutaneous biopsy is considered one of the most important diagnostic tools to evaluate diffuse liver diseases. The introduction and widespread diffusion of ultrasounds in medical practice has improved percutaneous bioptic technique, while reducing postoperative complications. Although ultrasonography has become almost ubiquitous in prebiopsy investigation, only one third of biopsies are performed under ultrasound control. Moreover, the one-day procedure, reported in several studies to be safe and cost effective, accounted for only 4% of biopsies done. We report our experience of 142 percutaneous US-guided biopsies performed on 140 patients affected by chronic diffuse liver disease over a four-year period. Liver biopsies were performed under US guidance at the patients bed using an anterior subcostal route. We evaluated postoperative pain, modifications of blood pressure and red cell count, hospital stay, morbidity and mortality rates, and adequacy of specimens for histologic examination. There was no operative mortality. As for major complications, one case of hemobilia occurred. As for minor complications, two cases of persistent postoperative pain required analgesic therapy. Patients were discharged the day following the procedure in all cases but two, who were discharged on the third and fifth postoperative days. Liver specimens were suitable for histologic diagnosis in all but one case, in which there were no portal spaces. According to our experience, we believe that hepatic biopsy guided by ultrasonography could replace blinded biopsy in the diagnosis of diffuse liver disease. The procedure is suitable to be performed safely on an outpatient basis.

Comparative study of laparoscopic vs open gastrectomy in gastric cancer management

AIM To compare long-term results of gastric cancer patients undergoing laparoscopic and open gastrectomy in a single unit. METHODS From February 2000 to September 2004, all patients with adenocarcinoma of the stomach were assessed to entry in this longitudinal prospective non-randomized trial. Primary endpoint was cancer-related survival and secondary endpoints were overall survival, evaluation of surgical complications and mortality. RESULTS Fifty-eight patients were enrolled. Forty-seven patients were followed-up (range 11-103, median 38 mo). Four patients were lost at follow up. Twenty-two patients underwent a laparoscopic gastric surgery (LGS) and 25 had a standard open procedure (OGS). No statistical difference was found between the two groups in terms of 5 years cancer-related mortality rate (50% vs 52%, P = 1), and 5 years overall mortality rate (54.5% vs 56%, P = 1). Accordingly, cancer-related and overall survival probability by Kaplan-Meier method showed comparable results (P = 0.81 and P = 0.83, respectively). We found no differences in surgical complications in the 2 groups. There was no conversion to open surgery in this series. CONCLUSION LGS is as effective as OGS in the management of advanced gastric cancer. However LGS cannot be recommended routinely over OGS for the treatment of advanced gastric cancer.

Ligation of the Intersphincteric Fistula Tract (LIFT): A Minimally Invasive Procedure for Complex Anal Fistula: Two-Year Results of a Prospective Multicentric Study

Introduction. The surgical management of anal fistulas is still a matter of discussion and no clear recommendations exist. The present study analyses the results of the ligation of the intersphincteric fistula tract (LIFT) technique in treating complex anal fistulas, in particular healing, fecal continence, and recurrence. Methods. Between October 2010 and February 2012, a total of 26 consecutive patients underwent LIFT. All patients had a primary complex anal fistula and preoperatively all underwent clinical examination, proctoscopy, transanal ultrasonography/magnetic resonance imaging, and were treated with the LIFT procedure. For the purpose of this study, fistulas were classified as complex if any of the following conditions were present: tract crossing more than 30% of the external sphincter, anterior fistula in a woman, recurrent fistula, or preexisting incontinence. Patient’s postoperative complications, healing time, recurrence rate, and postoperative continence were recorded during follow-up. Results. The minimum follow-up was 16 months. Five patients required delayed LIFT after previous seton. There were no surgical complications. Primary healing was achieved in 19 patients (73%). Seven patients (27%) had recurrence presenting between 4 and 8 weeks postoperatively and required further surgical treatment. Two of them (29%) had previous insertion of a seton. No patients reported any incontinence postoperatively and we did not observe postoperative continence worsening. Conclusion. In our experience, LIFT appears easy to perform, is safe with no surgical complication, has no risk of incontinence, and has a low recurrence rate. These results suggest that LIFT as a minimally invasive technique should be routinely considered for patients affected by complex anal fistula.

Laparoscopic Versus Open Ileo-Colonic Resection in Crohn’s Disease: Short- and Long-Term Results from a Prospective Longitudinal Study

Possible relations between surgical approaches, frequency, and severity of Crohn’s disease recurrence after ileo-colonic resection is unknown. We aimed to assess perioperative outcomes and postsurgical complications of laparoscopic versus standard open surgery and to detect differences between the two groups in endoscopical recurrence and patients’ satisfaction. Twenty-eight consecutive patients undergoing elective ileo-colonic resection by either laparoscopic approach (n = 15) or conventional open surgery (n = 13) were prospectively enrolled. No mortality or major intraoperative complications were observed in both groups. Significant differences between groups were the median operating time found shorter in the open group than in the laparoscopic group (p = 0.003), the higher dosage of pain killers needed in the open group (p = 0.05), the passage of flatus and\or stool after surgery found faster in group A (p = 0.004) and the shorter recovery period in the laparoscopic group (p = 0.007). Colonoscopy was performed in 27 patients. The frequency and pattern of recurrence did not differ between the two groups (p = 0.63). Patients’ satisfaction was significantly in favor of laparoscopy. Present findings support the feasibility and advantages in the short-term of laparoscopic ileo-colonic resection in patients with Crohn’s disease. No differences were observed in terms of frequency, time of onset, and severity of recurrence in a 1-year follow-up.

Reinterventions for specific technique-related complications of stapled haemorrhoidopexy (SH): a critical appraisal.

IntroductionStapled haemorrhoidopexy (SH) is an attractive alternative to conventional haemorrhoidectomy (CH) because of reduced pain and earlier return to normal activities. However, complication rates are as high as 31%. Although some complications are similar to CH, most are specifically technique-related. In this prospective audit, we report our experience with the management of some of these complications.MethodsData on patients undergoing SH at our unit or referred to us are prospectively entered in a database. The onset or duration of specific SH-related complications as well as reinterventions for failed or complicated SH was recorded.ResultsFrom 1/03 to 10/07, 110 patients underwent SH, while 17 patients were referred after complicated/failed SH. Overall early and late complication rates after SH were 12.7% and 27.2%, respectively. Overall reintervention rate was 9.1%. Among the referred SH-group, one patient underwent Hartmann’s procedure because of rectal perforation. The remaining 16 patients experienced at least one of the following: recurrence, urgency, frequency, severe persistent anal pain, colicky abdominal pain, anal fissure and stenosis. Four patients underwent CH with regular postoperative recovery. Two patients underwent exploration under anaesthesia because of persisting pain. One patient underwent anoplasty.ConclusionsSH presents unusual and challenging complications. Abuses should be minimized and longer-term studies are needed to further clarify its role.

Surgery for fistula-in-ano in a specialist colorectal unit: a critical appraisal

BackgroundSeveral techniques have been described for the management of fistula-in-ano, but all carry their own risks of recurrence and incontinence. We conducted a prospective study to assess type of presentation, treatment strategy and outcome over a 5-year period.MethodsBetween 1st January 2005 and 31st March 2011 247 patients presenting with anal fistulas were treated at the University Hospital Tor Vergata and were included in the present prospective study. Mean age was 47 years (range 16-76 years); minimum follow-up period was 6 months (mean 40, range 6-74 months).Patients were treated using 4 operative approaches: fistulotomy, fistulectomy, seton placement and rectal advancement flap. Data analyzed included: age, gender, type of fistula, operative intervention, healing rate, postoperative complications, reinterventions and recurrence.ResultsEtiologies of fistulas were cryptoglandular (n = 218), Crohns disease (n = 26) and Ulcerative Colitis (n = 3). Fistulae were classified as simple -intersphincteric 57 (23%), low transphincteric 28 (11%) and complex -high transphicteric 122 (49%), suprasphincteric 2 (0.8%), extrasphinteric 2 (0.8%), recto-vaginal 7 (2.8%) Crohn 26 (10%) and UC 3 (1.2%).The most common surgical procedure was the placement of seton (62%), usually applied in case of complex fistulae and Crohns patients.Eighty-five patients (34%) underwent fistulotomy, mainly for intersphincteric and mid/low transphincteric tracts. Crohns patients were submitted to placement of one or more loose setons.The main treatment successfully eradicated the primary fistula tract in 151/247 patients (61%). Three cases of major incontinence (1.3%) were detected during the follow-up period; Furthermore, three patients complained minor incontinence that was successfully treated by biofeedback and permacol injection into the internal anal sphincter.ConclusionsThis prospective audit demonstrates an high proportion of complex anal fistulae treated by seton placement that was the most common surgical technique adopted to treat our patients as a first line. Nevertheless, a good outcome was achieved in the majority of patients with a limited rate of faecal incontinence (6/247 = 2.4%). New technologies provide promising alternatives to traditional methods of management particularly in case of complex fistulas. There is, however, a real need for high-quality randomized control trials to evaluate the different surgical and non surgical treatment options.