Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy.

BACKGROUND: Minimally invasive techniques have become an integral part of general surgery, with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents a prospective, randomized, multicenter, single-blind trial of SILC compared with four-port cholecystectomy (4PLC) with the goal of assessing safety, feasibility, and factors predicting outcomes. METHODS: Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC or 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Pain, cosmesis, and quality-of-life scores were documented. Patients were followed for 12 months. RESULTS: Two hundred patients were randomized to SILC (n = 117) or 4PLC (n = 80) (3 patients chose not to participate after randomization). Patients were similar except for body mass index (BMI), which was lower in the SILC patients (28.9 vs. 31.0, p = 0.011). One SILC patient required conversion to 4PLC. Operative time was longer for SILC (57 vs. 45 min, p < 0.0001), but outcomes, including total adverse events, were similar (34% vs. 38%, p = 0.55). Cosmesis scores favored SILC (p < 0.002), but pain scores were lower for 4PLC (1 point difference in 10-point scale, p < 0.028) despite equal analgesia use. Wound complications were greater after SILC (10% vs. 3%, p = 0.047), but hernia recurrence was equivalent for both procedures (1.3% vs. 3.4%, p = 0.65). Univariate analysis showed female gender, SILC, and younger age to be predictors for increased pain scores, while SILC was associated with improved cosmesis scores. CONCLUSIONS: In this multicenter randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar biliary complication profile. Pain scores and wound complication rates are higher for SILC; however, cosmesis scores favored SILC. For patients preferring a better cosmetic outcome and willing to accept possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC. Further follow-up is needed to detail the long-term risk of wound morbidities, including hernia recurrence.

Preinductive use of clonidine and ketamine improves recovery and reduces postoperative pain after bariatric surgery.

BACKGROUND: In obese patients, concomitant use of clonidine and ketamine might be suitable to reduce the doses and minimize the undesired side effects of anesthetic and analgesic drugs. In this study, we evaluated the perioperative effects of administration of clonidine and ketamine in morbidly obese patients undergoing weight loss surgery at a university hospital in Rome, Italy. METHODS: A total of 50 morbidly obese patients undergoing open biliopancreatic diversion for weight loss surgery were enrolled. The patients were randomly allocated into a study group (n = 23) receiving a slow infusion of ketamine-clonidine before anesthesia induction and a control group (n = 27) who received standard anesthesia. The hemodynamic profile, intraoperative end-tidal sevoflurane and opioid consumption, tracheal extubation time, Aldrete score, postoperative pain assessment by visual analog scale, and analgesic requirements were recorded. RESULTS: The patients in the study group required less end-tidal sevoflurane, lower total doses of fentanyl (3.8 +/- 0.3 gamma/kg actual body weight versus 5.0 +/- 0.2 gamma/kg actual body weight, respectively; P <.05) and had a shorter time to extubation (15.1 +/- 5 min versus 28.2 +/- 6 min, P <.05). The Aldrete score was significantly better in the postanesthesia care unit in the study group. The study group consumed less tramadol than did the control group (138 +/- 57 mg versus 252 +/- 78 mg, P <.05) and had a lower visual analog scale score postoperatively during the first 6 hours. CONCLUSION: The preoperative administration of low doses of ketamine and clonidine at induction appears to provide early extubation and diminished postoperative analgesic requirements in morbidly obese patients undergoing open bariatric surgery.

The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial.

BACKGROUND: Published interim results have shown that fibrin sealant (Tissucol/Tisseel Baxter AG, Vienna, Austria) may be effective in preventing anastomotic leaks and internal hernias following laparoscopic Roux-en-Y gastric bypass (LRYGBP). We report the final results of a multicenter, randomized clinical trial evaluating the use of fibrin sealant in LRYGBP. METHODS: Between January 2004 and December 2005, 340 patients aged 21-65 years with a body mass index (BMI) of 40-59 kg/m(2) undergoing LRYGBP were randomized (1:1) to two treatment groups: fibrin sealant group (applied to gastrojejunal and jejunojejunal anastomoses and over mesenteric openings), and control group (no fibrin sealant; suture of the mesenteric openings). Operative time, early and late complications, reinterventions, time to oral diet initiation, and length of stay were assessed. RESULTS: Overall, 320 patients were included into the study: 160 in the control group and 160 in the fibrin sealant group. All patients completed follow-up assessments at 6 and 12 months, and 60.9% completed assessments at 24 months. There were no significant differences between groups with respect to demographics, operative time, oral diet initiation, hospital stay, and BMI reduction at 6, 12, and 24 months. The incidence of anastomotic leak was numerically, but not significantly, greater in the control group. The overall reintervention rate for specific early complications (<30 days) was significantly higher in the control group (p = 0.016). No deaths or conversions to open laparotomy occurred. CONCLUSION: The use of fibrin sealant in laparoscopic RYGBP may be beneficial in reducing the reintervention rate for major perioperative (<30 days) complications. Larger studies are needed.

Laparoscopy-assisted ERCP after biliopancreatic diversion.

Therapeutic biliary endoscopy after biliopancreatic diversion (BPD) for morbid obesity is not possible through the anatomical route. In the case of a long excluded afferent limb, the possibility to reach endoscopically the papilla through a surgical gastrostomy or jejunostomy has been reported. A case of laparoscopy-assisted ERCP performed 4 years after laparoscopic BPD with distal gastrectomy, is reported. Access to the papilla was obtained laparoscopically by enterotomy, insertion of a trocar into a jejunal loop 40 cm distal to the ligament of Treitz and passage of the duodenoscope through the trocar to the papilla. A guidewire was laparoscopically advanced into the cystic duct, and bile duct cannulation was achieved using the rendez-vous technique; endoscopic sphincterotomy and extraction of stones were successful. Laparoscopic cholecystectomy was performed and the enterotomy was sutured. The clinical course was uneventful.

Bowel length: measurement, predictors, and impact on bariatric and metabolic surgery.

BACKGROUND: Small bowel length (SBL) determines the caloric absorptive capacity. The aim of this study was to evaluate SBL to identify patient-specific predictors and the interrelationships of SBL with anthropometric variables. METHODS: Sex, age, and weight were recorded at the time of surgery when SBL and the estimated jejunal length (JLe) were measured by 3 different methods. RESULTS: The mean SBL of 443 patients undergoing laparotomy (78% female) was 690±93.7 cm (range 350-1049 cm). Sex was correlated with SBL, as men had a longer small bowel than women (729±85 versus 678±92, P<.0001) and were significantly taller (173±8.2 versus 161±6.9, P<.001). Age did not correlate with SBL. The differences in length between fully stretched small bowel and nonstretched small bowel and between fully stretched small bowel and laparoscopic bowel were 137±19 cm and 32.4±11.4 cm, respectively. In a multivariate linear regression analysis model that included sex, age, height, and weight, only height was significantly correlated with SBL (P<.00001) and explained 12% of the variance in SBL. Sex, age, height, and JLe, but not SBL, were statistically highly significant in predicting 75% of the variance of body weight. CONCLUSIONS: A positive association between height and SBL was found. Sex, age, height, and JLe may be strong predictors of weight. Individual JLe may be of importance in determining the weight loss and resolution of metabolic co-morbidities. Measuring the SBL can prevent the risk of nutritional consequences in malabsorptive, revisional, and metabolic procedures.

Ileal food diversion: a simple, powerful and easily revisable and reversible single-anastomosis gastric bypass.

BACKGROUND: Malabsorptive interventions are recognized as procedure of choice in metabolic surgery and the best strategy for re-do surgery when restriction failed. We describe a novel procedure, the ileal food diversion, an easy and effective non-restrictive one-anastomosis gastric bypass. METHODS: We report the preliminary results of a series of 68 consecutive patients performed by two surgeons in two different hospitals since 2009 (49 females, 13 re-do surgeries). RESULTS: Mean operating time was 65 min. All operations were performed by laparoscopy (three-trocar technique in 44 cases and 24 single-incision laparoscopies). Median follow-up is 9.6 months (range 2-48). Diabetes resolution was accomplished in 80% of patients. Average BMI decreases from 44 to 27 after 24 months. CONCLUSIONS: Ileal food diversion is an interesting option in super-obese patients, re-do surgery and patients with metabolic syndrome. Technical considerations, physiological assumptions and rationale were discussed.

Body composition and energy expenditure: relationship and changes in obese subjects before and after biliopancreatic diversion.

Changes in total and segmental body composition were studied in 101 obese women before and 2, 6, 12, and 24 months after biliopancreatic diversion (BPD) and data 24 months after surgery were matched to 53 control subjects. The patients were studied by anthropometry, indirect calorimetry, and double-emission x-ray absorptiometry (DXA). The combination of calorimetry and body composition analysis allowed estimation of visceral and muscle lean mass. We observed a significant (analysis of variance [ANOVA]: P <.05) progressive reduction of fat and lean body mass (LBM) following BPD, with stabilization of both parameters between 12 and 24 months at levels not different from controls. Fat loss was significant in the arms, legs, and trunk segments. After 24 months, there was no significant difference in segmental fat mass between post-BPD patients and controls. Calorimetric data seem to confirm lean body mass (LBM) reduction. Visceral lean mass (kg) was significantly reduced from 8.1 +/- 2.2 in obese subjects to 6.5 +/- 1.8 in post-BPD patients at 24 months (P <.05); the control value was 7.2 +/- 1.8. Muscular lean mass (kg) was also significantly reduced, from 50.2 +/- 5.8 to 39.8 +/- 5.7 in the same subjects (P <.05), with a control value of 42.5 +/- 5.9. The decrease in muscle and visceral LBM reached control values without significant differences. Viscera/muscle ratio in pre-BPD patients was preserved in post-BPD patients at 24 months, but it was reduced during weight loss. Body composition studies showed a logarithmic relationship between fat and lean mass and a physiological contribution of lean mass to weight loss in the BPD patients. In conclusion, weight loss after BPD was achieved with an appropriate decline of LBM and with all parameters reaching, at stable weight, values similar to weight-matched controls.

Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of significantly higher hernia rates: 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy.

BACKGROUND: Minimally invasive techniques have become an integral part of general surgery with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents the final 1-year results of a prospective, randomized, multicenter, single-blinded trial of SILC vs multiport cholecystectomy (4PLC). STUDY DESIGN: Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC vs 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Patients were followed for 12 months. RESULTS: Two hundred patients underwent randomization to SILC (n = 119) or 4PLC (n = 81). Enrollment ranged from 1 to 50 patients with 4 sites enrolling >25 patients. Total adverse events were not significantly different between groups (36% 4PLC vs 45% SILC; p = 0.24), as were severe adverse events (4% 4PLC vs 10% SILC; p = 0.11). Incision-related adverse events were higher after SILC (11.7% vs 4.9%; p = 0.13), but all of these were listed as mild or moderate. Total hernia rates were 1.2% (1 of 81) in 4PLC patients vs 8.4% (10 of 119) in SILC patients (p = 0.03). At 1-year follow-up, cosmesis scores continued to favor SILC (p < 0.0001). CONCLUSIONS: Results of this trial show SILC to be a safe and feasible procedure when compared with 4PLC, with similar total adverse events but with an identified significant increase in hernia formation. Cosmesis scoring and patient preference at 12 months continue to favor SILC, and more than half of the patients were willing to pay more for a single-site surgery over a standard laparoscopic procedure. Additional longer-term population-based studies are needed to clarify if this increased rate of hernia formation as compared with 4PLC will continue to hold true.

Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data.

BACKGROUND: This study presents preliminary data from a prospective randomized multicenter, single-blinded trial of single-incision laparoscopic cholecystectomy (SILC) versus standard laparoscopic cholecystectomy (4PLC). METHODS: Patients with symptomatic gallstones, polyps, or biliary dyskinesia (ejection fraction <30%) were randomized to SILC or 4PLC. Data included operative time, estimated blood loss, length of skin and fascial incisions, complications, pain, satisfaction and cosmetic scoring, and conversion. RESULTS: Operating room time was longer with SILC (n = 50) versus 4PLC (n = 33). No differences were seen in blood loss, complications, or pain scores. Body image scores and cosmetic scores at 1, 2, 4, and 12 weeks were significantly higher for SILC. Satisfaction scores, however, were similar. CONCLUSIONS: Preliminary results from this prospective trial showed SILC to be safe compared with 4PLC although operative times were longer. Cosmetic scores were higher for SILS compared with 4PLC. Satisfaction scores were similar although both groups reported a significantly higher preference towards SILC.

Single-incision laparoscopic gastric bypass for morbid obesity.

BACKGROUND: Single-incision laparoscopic surgery (SILS) has been developed with the aim of reducing the invasiveness of traditional laparoscopy. METHODS: The technique of single-incision laparoscopic gastric bypass performed through a single intra-umbilical incision was adopted in 16 obese patients and minutely described. Fourteen patients underwent single-loop gastric bypass and two patients underwent "double loop" (Roux-en-Y) gastric bypass. RESULTS: Operating time was less than 2 h in all cases. All procedures were completed with the single-access technique. There were no major per-operative complications. Patients were early-discharged after an upper GI examination and restoration of a liquid diet. CONCLUSIONS: Emerging technology has contributed to the diffusion of SILS; single-incision laparoscopy is validated and established in cholecystectomy and is gaining acceptance in other techniques also. High technical skill is required for manipulating, measuring, and suturing the bowel with articulated instruments. However, randomized, controlled trials are required to determine the real advantages of this technique in comparison with standard laparoscopy.

Laparoscopic gastric banding without visible scar: a short series with intraumbilical SILS.

Single-incision laparoscopic surgery has been developed with the aims of further reducing the invasiveness of traditional laparoscopy. The technique of lap-band placement from a single intraumbilical incision is described. Three patients underwent a single-incision laparoscopic surgery gastric banding (SILS-GB) for morbid obesity from May to September 2008. All interventions were uneventful and patients were discharged on first postoperative day, after an upper gastrointestinal series. SILS-GB is virtually scarless intervention and may be performed as a day-surgery procedure for the treatment of morbid obesity.

Evaluation of antioxidant systems (coenzyme Q10 and total antioxidant capacity) in morbid obesity before and after biliopancreatic diversion.

Biliopancreatic diversion (BPD) is a surgical procedure performed in patients with untreatable obesity and insulin resistance. The demonstrated metabolic and hormonal results of this procedure include the reversal of insulin resistance; an increase in diet-induced thermogenesis; and modifications of gut hormones, such as gastrin, enteroglucagon, neurotensin, and cholecystokinin. On the other hand, obesity is a condition of increased oxidative stress; however, few studies have investigated antioxidant systems in obese persons with BPD. To evaluate the metabolic status and antioxidant systems in such patients, we studied a group of 11 morbidly obese patients, aged 28 to 62 years, with a mean body mass index (BMI) of 54.71 +/- 2.52 kg/m(2), before and after successful BPD (mean post-BPD BMI, 44.68 +/- 1.51 kg/m(2)). A control group composed of 10 slightly overweight women, with a mean BMI of 28.5 +/- 0.72 kg/m(2), was also studied. Coenzyme Q(10) (CoQ(10)) levels (also normalized for cholesterol levels) and total antioxidant capacity in blood plasma were assessed in these populations. The most striking datum was the extremely low level of CoQ(10) in postoperative period (0.34 +/- 0.16 vs 0.66 +/- 0.09 mug/mL, P = .04); also, the data corrected for cholesterol levels presented the same pattern, with a more marked significance (152.46 +/- 11.13 vs 186.4 +/- 17.98 nmol/mmol, P = .001). This could be due to lipid malabsorption after surgery. In fact, the pre-BPD data present all the metabolic and hormonal characteristics of severe obesity; and after BPD, there was a net improvement in the metabolic parameters. The first pathophysiologic phenomenon seems to be lipid malabsorption that has been argued to be the cause of insulin resistance reversion. This metabolic interpretation is also confirmed by the absence of significant variations of total antioxidant capacity (57.5 +/- 5.3 vs 66 +/- 5.3). The mechanisms of these phenomena remain to be established. These data suggest the importance of correcting postsurgical metabolic complications, in these clinical populations, with CoQ(10) supplementation.