Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds. STUDY DESIGN: This prospective, multi-institutional study evaluated P4HB VIHR in comorbid patients with CDC class I wounds. Primary outcomes included hernia recurrence and surgical site infection. Secondary outcomes included pain, device-related adverse events, quality of life, reoperation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6, 12, 18, 24, 30, 36, and 60 months. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics. RESULTS: A total of 121 patients (46 male, 75 female) 54.7 ± 12.0 years old with a BMI of 32.2 ± 4.5 kg/m 2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed the 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60 months) included recurrence (22.0 ± 4.5%; 95% CI 11.7% to 29.4%) and surgical site infection (10.1 ± 2.8%; 95% CI 3.3 to 14.0). Secondary outcomes included seroma requiring intervention (n = 9), procedure time (167.9 ± 82.5 minutes), length of stay (5.3 ± 5.3 days), reoperation (18 of 121, 14.9%), visual analogue scale-pain (change from baseline -3.16 ± 3.35 cm at 60 months; n = 52), and Carolinas Comfort Total Score (change from baseline -24.3 ± 21.4 at 60 months; n = 52). CONCLUSIONS: Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework for anticipated long-term hernia repair outcomes when using P4HB mesh.

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

BACKGROUND: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. MATERIALS AND METHODS: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. RESULTS: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. CONCLUSIONS: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

Weight Loss and Timing of J Tube Removal in Biliopancreatic Diversion with Duodenal Switch Patients Who Report Physical or Sexual Abuse.

BACKGROUND: Bariatric surgery patients who report physical or sexual abuse form a sizeable cohort that stands out due to psychological comorbidity. Their possible vulnerability to suboptimal weight loss remains of interest. Their risk for malnutrition due to inadequate oral intake following surgery is underexplored. OBJECTIVES: Study aims were to determine the effect of self-reported physical or sexual abuse in patients undergoing open biliopancreatic diversion with duodenal switch (BPD/DS) on (a) 3-year weight loss trajectories and (b) timing of feeding jejunostomy tube (J tube) removal. Delayed J tube removal served as an indicator for inadequate oral intake. METHODS: In this retrospective cohort study, the sample (N = 189) consisted of all patients who underwent primary BPD/DS by the same surgeon during 2009 and 2010 at a Midwestern health system. All patients had a J tube placed during surgery. Longitudinal mixed models were used for testing differences in weight loss trajectories by abuse status. RESULTS: There were no significant differences in weight loss trajectories by abuse status. The abused group had the J tube in place a mean of 61.9 days (SD = 39.5) compared to 44.8 days (SD = 32.8) for the not abused group, a significant difference. CONCLUSIONS: Our use of the best available statistical methods lends validity to previous findings that suggest physical or sexual abuse does not affect weight loss after bariatric surgery. Increased likelihood of persistent inadequate oral intake in the abused group suggests the need for early multidisciplinary interventions that include mental health and nutrition experts.

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh. METHODS: This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing. RESULTS: One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively. CONCLUSIONS: High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

Maintenance of weight loss in patients with body mass index >60 kg/m2: importance of length of small bowel bypassed.

BACKGROUND: It is commonly believed that weight loss after biliopancreatic diversion/duodenal switch is inversely related to the length of the alimentary limb and the common channel. However, the effect of the biliopancreatic limb length (BPL) on weight loss has received little attention. METHODS: A total of 1001 patients after biliopancreatic diversion/duodenal switch (209 men and 792 women, mean age 42 +/- 10 yr, mean body mass index [BMI] 52 +/- 9 kg/m(2)) were divided into 2 groups according to the ratio of the BPL to the total small bowel length (SBL): a BPL < or =45% of the SBL versus a BPL >45% of the SBL. The nutritional parameters and percentage of excess weight loss were compared between the 2 groups. RESULTS: In patients with a BMI of < or =60 kg/m(2), the percentage of excess weight loss at 1 year postoperatively was 66.8% for those with a BPL < or =45% of the SBL and 69.3% for those with a BPL >45% of the SBL (P = NS). At 2 years, the corresponding percentages were 73.7% and 79.5% (P = NS) and, at 3 years, were 73.4% and 75.2% (P = NS). In patients with a BMI >60 kg/m(2), the corresponding percentages of excess weight loss was 56.8% versus 61.4% (P = .07) at 1 year, 62.2% versus 77.5% (P = .04) at 2 years, and 59.8% versus 77.5% at 3 years (P = .05). CONCLUSION: The results of our study have shown that amount of weight lost after biliopancreatic diversion/duodenal switch is directly related to the proportion of small bowel bypassed in patients with a BMI >60 kg/m(2). Also, the effect increased with the duration of follow-up. In less heavy patients, the BPL/SBL ratio had a minimal effect on long-term weight loss and a more pronounced effect on nutritional parameters.

Revision of the duodenal switch: indications, technique, and outcomes.

BACKGROUND: Duodenal switch (DS) operation combines both restrictive and malabsorptive components and has become an accepted operation in selected patients with morbid obesity. Complications develop in some patients, which are refractory to dietary supplementation. We report a series of 33 patients who required partial revision of the DS. STUDY DESIGN: During the 10-year period after September 1992, 701 patients had DS operation performed; of these, 33 (5 men and 28 women) patients required revision. Revision was performed by side to side enteroenterostomy 100 cm proximal to the original anastamosis. Outcomes measures reviewed include postoperative complications, nutritional parameters, and weight change. RESULTS: Revision was performed a median of 17 (range 7 to 63) months after DS. Indications for revision included protein malnutrition (n = 20), diarrhea (n = 9), metabolic abnormalities (n = 5), abdominal pain (n = 3), liver disease (n = 2), emesis (n = 2), and gastrointestinal bleed (n = 1). Median body mass index at the time of revision was 28. Median serum albumin was 3.6 g/dL and improved to 4.0 g/dL postoperatively (p = 0.01). Complications occurred in 5 of 32 patients (15%) and included wound infection (n = 2), respiratory failure (n = 1), gastrointestinal bleed (n = 1), and small bowel obstruction (n = 1). There was no perioperative mortality. During a median followup period after revision of 39 months, the median weight gain was 18 pounds. Three patients requested repeat operation because of weight regain. CONCLUSIONS: Patients requiring revision of DS for malnutrition can be corrected by a technically simple procedure, but they are at considerable risk for complications. Although many patients are anxious about regaining their weight after reversal, they can be reassured that substantial weight gain is unlikely.

Sleeve gastrectomy in the high-risk patient.

BACKGROUND: One of the surgical options available for the super-obese patient is the sleeve gastrectomy. We present results of this operation in a series of 118 patients. METHODS: The charts of all patients who have had the sleeve gastrectomy performed were reviewed for demographic data, complications, weight, and nutritional parameters. RESULTS: Median age was 47 years (16-70). Median BMI was 55 kg/m(2) (37-108), with 73% of patients having a BMI > or =50 kg/m(2). 41% of the patients were male. The operation was performed by laparotomy in all but three cases, which were performed laparoscopically. Median hospital stay was 6 days (3-59). There was one perioperative death (0.85%). 18 patients (15.3%) had postoperative complications. Median percent excess weight loss was 37.8% at 6 months, 49.4% at 12 months, and 47.3% at 24 months. Median follow-up was 13 months (1-66). At 1 year postoperatively, the percentage of patients with normal serum levels of albumin was 100%, hemoglobin 86.1%, and calcium 87.2%, compared to 98.1%, 85.6%, and 94.3% preoperatively. 6 patients requested conversion to a duodenal switch during the follow-up period; all left the hospital in 4-6 days without major complication. CONCLUSIONS: Although the sleeve gastrectomy does not result in as much weight loss as the duodenal switch or gastric bypass, it can be used as a stand-alone operation or as a bridge to more complex procedures in the high-risk super-obese patient.

The duodenal switch operation for morbid obesity.

The duodenal switch provides excellent weight loss with preservation of good alimentation, even in the superobese. This is accomplished with acceptable operative mortality and minimal dietary limitations and metabolic sequelae. The results of the duodenal switch that are reported in the literature should remove any inhibitions that exist about the use of this procedure as treatment for patients who have morbid obesity. This article discusses the duodenal switch operation for morbid obesity.

Emergence and recovery characteristics of desflurane versus sevoflurane in morbidly obese adult surgical patients: a prospective, randomized study.

We compared postoperative recovery after desflurane (n = 25) versus sevoflurane (n = 25) anesthesia in morbidly obese adults (body mass index >/=35) who underwent gastrointestinal bypass surgery via an open laparotomy. After premedication with midazolam and metoclopramide 1 h before surgery, epidural catheter placement, induction of anesthesia with fentanyl and propofol, and tracheal intubation facilitated with succinylcholine, anesthesia was maintained with age-adjusted 1 minimum alveolar concentration (MAC) desflurane or sevoflurane. Fentanyl IV, morphine or local anesthetics epidurally, and vasoactive drugs as needed were used to maintain arterial blood pressure at +/-20% of baseline value and to keep bispectral index of the electroencephalogram values between 40 to 60 U. Although patients were anesthetized with desflurane for a longer time (261 +/- 50 min versus 234 +/- 37 min, mean +/- sd; P < 0.05, desflurane versus sevoflurane, respectively) and for more MAC-hours (4.2 +/- 0.9 h versus 3.7 +/- 0.8 h; P < 0.05), significantly earlier recovery of response to command and tracheal extubation occurred in patients given desflurane than in patients given sevoflurane. The modified Aldrete score was greater in desflurane-anesthetized patients on admission to the postanesthesia care unit (PACU) (P = 0.01) but not at discharge (P = 0.47). On admission to PACU, patients given desflurane had higher oxygen saturations (97.0% +/- 2.4%) than patients given sevoflurane (94.8% +/- 4.4%, P = 0.035). Overall, the incidence of postoperative nausea and vomiting and the use of antiemetics did not differ between the two anesthetic groups. We conclude that morbidly obese adult patients who underwent major abdominal surgery in a prospective, randomized study awoke significantly faster after desflurane than after sevoflurane anesthesia and the patients anesthetized with desflurane had higher oxygen saturation on entry to the PACU.

Patterns of Internet use: bariatric versus colorectal patients in a private institution.

BACKGROUND: The frequency of Internet use for self-directed medical care in different patient populations is increasing. We evaluated Internet use by patients presenting for bariatric surgery. STUDY DESIGN: Surveys were completed by 136 patients (109 women, 22 men) presenting to a private academic clinic for bariatric surgery. Data collected included age, gender, education level, household income, and pattern of Internet use. Comparisons were made with a group of 135 patients who visited a colorectal surgery clinic in the same institution. RESULTS: Bariatric patients who used the Internet were more likely than colorectal patients to inform themselves about their medical problem (76% versus 49%, p < 0.001) and tended to use the Internet more overall (85% versus 78%, p = ns). Use of the Internet to research bariatric surgery was associated with education level (p = 0.002) and household income (p = 0.01), but not with age or gender. Bariatric patients were more likely than colorectal patients to search our institution's Web site (40% versus 17%, p < 0.001) and to use the Internet to find out about their surgeon (47% versus 31%, p = 0.01). Only 9% of bariatric patients used a chat room. Ninety-six percent of bariatric patients found the information on the Internet easy to understand and 58% described it as very helpful. CONCLUSIONS: Bariatric patients are especially likely to use the Internet to gain information about their medical condition, possibly reflecting their limited mobility. This represents an educational opportunity for the surgical community.

Longitudinal gastrectomy as a treatment for the high-risk super-obese patient.

BACKGROUND: Bariatric surgery in patients with significant co-morbid conditions is associated with increased perioperative risk. METHODS: From 1995-2001, 795 patients were operated upon at our institution for the diagnosis of morbid obesity. Of these, 671 (84.4%) had the duodenal switch (DS) procedure. Longitudinal gastrectomy (LG) entails a greater curvature linear gastrectomy creating a gastric tube with a volume of 100 ml along the lesser curvature of the stomach. This procedure was performed for 21 patients (median age 50.5, median BMI 56). 9 patients were offered LG preoperatively because of their known high perioperative risks. 12 patients were initially planned for DS, but the procedure was limited to LG alone because of either unexpected intraoperative findings (n=9) or intraoperative hemodynamic instability (n=3). 5 patients developed complications, and there were no deaths. RESULTS: 19 out of 21 patients were available for a median follow-up of 17.5 months (6.25-20.25). Median weight loss and median %EWL at 12 months were 44.5 kg and 45.1%, respectively. Estimated daily dietary volume at 1 year was 35% of preoperative values. Of 10 patients followed for >or= 1 year, 4 of 10 achieved more than 50% EWL and 8 patients were taking less or were completely off medications for diabetes, hypertension and congestive heart failure. Weight loss plateaued at 1 year for the majority of patients. CONCLUSIONS: LG is a safe and effective option for high-risk morbidly obese patients. Weight reduction is accomplished by limitation of caloric intake. LG can be offered to high-risk morbidly obese patients as an interim procedure to help decrease perioperative risk before DS.

Surgical treatment of morbid obesity in schizophrenic patients.

BACKGROUND: Newer antipsychotic medications have greatly improved the treatment of schizophrenia, but they are known to be associated with serious weight gain. Little is known about treatment of morbid obesity in this population. METHODS: 5 patients with schizophrenia and morbid obesity were studied. Weight loss was compared with that achieved by 165 non-psychotic patients who also underwent bariatric surgery during a 1-year period. RESULTS: 5 morbidly obese patients with schizophrenia underwent bariatric surgery between February 1999 and April 2003. All patients were well controlled on antipsychotics. The median BMI was 54 (51-70) and all had obesity-related co-morbidities. All patients had been previously treated unsuccessfully with conservative methods of weight reduction. 3 patients had a duodenal switch operation, 1 patient had a sleeve gastrectomy, and 1 had conversion of a silastic ring gastroplasty to biliopancreatic diversion. All patients were maintained on their antipsychotic medications until 24 hours before surgery. Median percent excess weight loss at 6 months was comparable to that achieved in the control group. CONCLUSIONS: Good control of schizophrenia may be achieved by newer therapies but at the risk of weight gain. The results of bariatric surgery in such patients are comparable to those of non-psychotic morbidly obese patients. Further follow-up is needed, but the results are encouraging.

The duodenal switch operation for the treatment of morbid obesity.

OBJECTIVE: To determine the safety and efficacy of the duodenal switch procedure as surgical treatment of morbid obesity. SUMMARY BACKGROUND DATA: The longitudinal gastrectomy and duodenal switch procedure as performed for morbid obesity involves a 75% subtotal greater curvature gastrectomy and long limb suprapapillary Roux-en-Y duodenoenterostomy. This results in a restricted caloric intake and diversion of bile and pancreatic secretions to induce fat malabsorption. Broad acceptance of this procedure has been impeded because of concerns that the malabsorptive component may produce serious nutritional complications. METHODS: Review of data collected prospectively from all patients who underwent duodenal switch as the primary surgical treatment of morbid obesity at a single institution during the 10-year period beginning September 1992. Operative morbidity and mortality, weight loss, volume of food intake, and bowel function were recorded. Sequential measurements of serum albumin, hemoglobin, and calcium levels were obtained to assess metabolic function and nutrient absorption. RESULTS: Duodenal switch was performed as the primary operation in 701 (81%) of a total 863 patients undergoing bariatric surgery during the period of study. The average body mass index (BMI) was 52.8 (range, 34-95). Perioperative mortality was 1.4%, and morbidity (including leaks, wound dehiscence, splenectomy, and postoperative hemorrhage) occurred in 21 patients (2.9%). Weight loss averaged 127 pounds at 1 year, 131 at 3 years, and 118 at 5 or more years (% EBWL of 69%, 73%, and 66%, respectively). The mean number of bowel movements was fewer than 3 per day. Patients reported and maintained a mean restriction of 63% of their preoperative intake (approximately 1600 calories), with no specific food intolerance, at 3 or more years follow-up. At 3 years, serum albumin remained at normal levels in 98% of patients, hemoglobin in 52%, and calcium in 71%. No patients reported dumping, and marginal ulcers were not seen. CONCLUSIONS: The longitudinal gastrectomy with duodenal switch is a safe and effective primary procedure for the treatment of morbid obesity. It has the advantage of allowing acceptable alimentation with a minimum of side effects while producing and maintaining significant weight loss. These results are achieved without developing significant dietary restrictions or clinical metabolic or nutritional complications.

Rhabdomyolysis of gluteal muscles leading to renal failure: a potentially fatal complication of surgery in the morbidly obese.

BACKGROUND: Rhabdomyolysis is a well-known cause of renal failure and is most commonly caused by ischemia/reperfusion or crush injury. We describe a new cause of this syndrome in a series of 6 patients who underwent necrosis of the gluteal muscles after bariatric surgery, 3 of whom eventually died of renal failure. METHODS: Potential etiologic factors were studied by comparing these patients with a consecutive series of 100 patients undergoing primary uncomplicated bariatric surgery during a 1-year period. Demographics, preoperative BMI, co-morbidities, duration of operation, and postoperative creatinine phosphokinase (CPK) levels. RESULTS: All patients presented with an area of buttock skin breakdown initially diagnosed as a simple decubitus ulcer. All had extensive myonecrosis of the medial gluteal muscles requiring extensive debridement. 5 of the 6 patients were male, with median BMI 67 compared with a median BMI 55 in the control group (P=0.0022). The patients were on the operating-room table for a median of 5.7 hours compared with 4.0 in the control group (P=0.01). 3 of the 6 developed renal failure requiring dialysis, which was fatal in all. One other patient developed a transient elevation of BUN and creatinine which did not require dialysis. Since recognition of this pattern, we now routinely perform serial CPK measurements. Median CPK rise in uncomplicated patients was to 1,200 mg/dl (SD 450-9,000), while CPK in affected patients ranged from 26,000 to 29,000 IU/l. We now routinely add additional buttock padding in very obese patients and institute aggressive hydration and mannitol diuresis if CPK rises above 5,000. No cases have occurred in the past 18 months in 220 patients. CONCLUSIONS: This is an important and potentially fatal complication of bariatric surgery. Very obese male patients with prolonged surgery are at risk of gluteal muscle necrosis with consequent renal failure, which we hypothesize is due to pressure by the operating-table leading to rhabdomyolysis and the creation of a compartment syndrome. Prevention may be aided by attention to intraoperative padding and positioning, and by limiting the duration of the operation.

Achalasia in the context of morbid obesity: a rare but important association.

BACKGROUND: The simultaneous occurrence of achalasia and morbid obesity is rare. Nevertheless, the surgical therapy of morbid obesity may be harmful, if undiagnosed achalasia were left untreated. We report the clinical presentation and response to treatment of achalasia in the context of morbid obesity. METHODS: From 1998 to 2002, 638 patients underwent surgery for morbid obesity. Preoperative upper gastrointestinal radiography was performed in all patients. Three patients had manometric confirmation of achalasia. The characteristic symptoms were recurrent episodes of regurgitation, chronic cough and aspiration. No patient reported dysphagia or recent weight loss. RESULTS: All patients had a duodenal switch procedure and in two a concurrent Heller myotomy was added. The other patient required a Heller myotomy after a duodenal switch had been performed, because the motility study was initially misinterpreted. All patients reported gradual resolution of presenting symptoms after myotomy. CONCLUSIONS: A careful symptomatic history focusing on aspiration, regurgitation and cough may identify the unusual combination of achalasia and morbid obesity. Treatment of morbid obesity alone may lead to progression of pulmonary symptoms.