Medical malpractice and hernia repair: an analysis of case law.

BACKGROUND: Litigation analysis and clinician education are essential to reduce the number and cost of malpractice claims. This study evaluates the clinical characteristics and legal outcomes of medical malpractice litigation initiated by patients having undergone a hernia repair operation. MATERIALS AND METHODS: Published civil suits were obtained from a legal database for state and federal decisions constituting case law. The published material includes information on defendants, plaintiffs, allegations, outcomes, and a variety of legal issues. A retrospective review of 44 published cases from 25 states was performed. RESULTS: Complications were present in 20 of 44 (45%) suits, four (9%) of which were because of infection. Death occurred in five (11%) cases, and failure to obtain informed consent was alleged in seven (16%) of the suits. Retained foreign bodies were present in 7 of the 44 (16%) suits. Other allegations included incorrect surgical technique, insufficient need for surgery, and emotional distress. Most (64%) patients initiating malpractice litigation were male, and inguinal, hiatal, and ventral hernia repairs account for 39%, 27%, and 14% of cases, respectively. Most suits (40%) were initiated in Southern states. Surgical mesh was indicated in 5 of 44 (11%) suits but four of five were unrelated to the suit. One patient initiated litigation because of the fact that the surgeon did not use mesh during surgery, which was discussed preoperatively during the informed consent. The court ruled in favor of the plaintiff in 12 of 44 (27%) suits, with compensation ranging from roughly $19,000 to $8,000,000. Louisiana and New York had six and seven suits each, which appears disproportionate given their respective populations. CONCLUSION: Complications and death resulting from alleged clinical negligence play a significant role in both the initiation and the outcome of malpractice litigation. Retained foreign bodies and lack of informed consent account for roughly one-third of malpractice litigation associated with hernia repairs. Many of these suits may be avoided with proper patient education and documentation of such along with standard operative preventative measures.

Comparative study of wound complications: isolated panniculectomy versus panniculectomy combined with ventral hernia repair.

BACKGROUND: The resection of an abdominal pannus carries the risk of wound-related morbidity in obese patients. Surgeons often perform a panniculectomy (PAN) to gain better access to the abdomen to perform other operations. We evaluated the incidence of wound complications after PAN with and without a concomitant procedure (i.e., ventral hernia repair [VHR]). METHODS: We reviewed the prospective data from all patients who underwent PAN alone and PAN combined with VHR from 2007 to 2011 at a single institution. The demographic data, operative information, and postoperative wound complications and interventions were recorded and analyzed using standard statistical methods. Multivariate logistic regression analysis was performed to control for confounding factors. RESULTS: After excluding the patients who had undergone concomitant procedures involving the gastrointestinal or genitourinary tract, 185 patients were included in the present study (143 patients in the PAN-VHR group and 42 in the PAN group). The average patient age was 55.4 and 47.6 years in the two groups (P = 0.001). The average body mass index was 38.0 and 41.1 kg/m(2) (P = 0.69). Of the 143 patients in the PAN-VHR group, 81.1% were women. In the PAN group, 92.9% were women (P = 0.09). The mean length of follow-up was 6.5 and 3.3 mo in the PAN-VHR and PAN groups, respectively (P = 0.04). In the PAN-VHR group, 96.5% underwent hernia repair with mesh and 29% underwent component separation. Subcutaneous talc was used in 58.6% of the PAN-VHR patients and 38.1% of the PAN patients (P = 0.02). Wound pulse-a-vac irrigation with bacitracin solution was used in 37.1% of PAN-VHR patients and 19.1% of the PAN patients (P = 0.03). The rate of wound complications and interventions for the PAN-VHR and PAN groups were not significantly different statistically (P < 0.05) and included seroma, seroma drainage, wound breakdown or necrosis, cellulitis, wound interventions, including bedside debridement and vac placement, and reoperation. After controlling for age, gender, body mass index, talc use, and pulse-a-vac irrigation use in the multivariate logistic regression analysis, the PAN-VHR group were more likely to develop cellulitis than the PAN-alone group (P = 0.004). The rates of all other wound complications were not significantly different statistically between the two groups after adjusting for confounding factors. CONCLUSIONS: PAN is associated with a significant risk of wound-related complications. The risk of postoperative cellulitis is increased further in patients who undergo concomitant VHR. However, the risk of all other wound complications and the need for interventions was not increased by performing concomitant VHR.

Umbilical hernia repair with mesh: identifying effectors of ideal outcomes.

BACKGROUND: Quality of life has become an important focus for improvement in hernia repair. METHODS: The International Hernia Mesh Registry was queried. The Carolinas Comfort Scale quantitated quality of life at 1-month, 6-month, and annual follow-up. Scores of 0 (completely asymptomatic) in all categories without recurrence defined an ideal outcome. RESULTS: The analysis consisted of 363 umbilical hernia repairs; 18.7% were laparoscopic. Demographics included age of 51.5 ± 13.8 years, 24.5% were female, and the average body mass index was 30.63 ± 5.9 kg/m(2). Mean defect size was 4.3 ± 3.1 cm(2). Mean follow-up was 18.2 months. Absent/minimal preoperative symptoms were predictive of ideal outcome at all time points and increasing age was predictive at 6 months and 1 year. At 6 months, the use of fixation sutures alone versus tacks (odds ratio 14.1) predicted ideal outcome. CONCLUSIONS: Ideal outcomes are dependent on both patient-specific and operative factors. The durable, ideal outcome in umbilical hernia repair is most likely in an older, asymptomatic patient who undergoes mesh fixation with permanent suture.

Preoperative pain is the strongest predictor of postoperative pain and diminished quality of life after ventral hernia repair.

With evolution of hernia repair surgery, quality of life (QOL) became a major outcome measure in nearly 350,000 ventral hernia repairs (VHRs) performed annually in the United States. This study identified predictors of chronic pain after VHR. A prospective database of patient-reported QOL outcomes at a tertiary referral center was queried from 2007 to 2010; 512 patients met inclusion criteria. Factors including demographics, medical comorbidities, preoperative symptoms, and hernia characteristics were analyzed using advanced statistical modeling. Average age was 56.4 years, 57.6 per cent were males, mean body mass index was 33 kg/m(2), hernia defect size was 138 cm(2), and 35.5 per cent were repaired laparoscopically. Preoperatively, 69 per cent of patients had mild and 28 per cent severe pain during some activities. Pain levels were elevated in the first month postoperatively; by 6 months, patients reported significant improvement. The most significant and consistent predictor of postoperative pain was the presence of preoperative pain (odds ratio, 2.1; 95% confidence interval, 1.4 to 3.0; P = 0.0001). Older patients and men had less postoperative pain, but they also had less preoperative pain, so these factors were not independent predictors. Patients with minimal preoperative symptoms uniformly experienced resolution of pain by 6 months postoperatively. Among patients with severe preoperative pain, one-third reported long-term resolution of pain, and one-third had persistent severe pain. The former group had smaller hernias (91 vs 194 cm(2), respectively, P = 0.015). Cases of new-onset, long-term pain after VHR were rare (less than 2%). Most patients' symptoms resolve by 6 months after surgery, but those with severe preoperative pain are at risk for persistent postoperative pain.

Postoperative quality of life after open transinguinal preperitoneal inguinal hernia repair using memory ring or three-dimensional devices.

A transinguinal preperitoneal (TIPP) approach has become a common technique for inguinal hernia repair. Our goal was to compare the impact of the two mesh designs for this operation: a flat mesh with a memory ring device (MRD) or a three-dimensional device (3DD) containing both onlay and preperitoneal mesh components. The prospective International Hernia Mesh Registry (2007 to 2012) was queried for MRD and 3DD inguinal hernia repairs. Outcomes and patient quality of life (QOL), using the Carolinas Comfort Scale (CCS), were examined at 1, 6, 12, and 24 months. Standard statistical methods were used, and multivariate logistic regression was performed using a forward stepwise selection method. TIPP was performed in 956 patients. Their average age 57.4 ± 15.3 years, 94.0 per cent were male, and mean body mass index was 25.7 ± 3.2 kg/m(2). MRD was used in 131 and 3DD in 825. Follow-up was 97, 82, 87, and 80 per cent at 1, 6, 12, and 24 months, respectively. Complications were not significantly different (P > 0.05). Recurrence was 0.8 per cent for MRD and 2.1 per cent for 3DD (P = 0.45). Comparing patient outcomes of MRD with 3DD at 1 month, 18.9 versus 11.5 per cent had symptoms of mesh sensation (P = 0.02); 28.7 versus 14.8 per cent had movement limitations (P < 0.01). MRD use was a significant independent predictor of movement limitation (odds ratio, 2.3; confidence interval, 1.4 to 3.7). No significant differences in CCS scores were seen at 6, 12, and 24 months. TIPP repair is safe and has a low recurrence rate. Early postoperative QOL is significantly improved with a 3DD mesh compared with MRD.

Radiofrequency ablation offers a reliable surgical modality for the treatment of Barrett's esophagus with a minimal learning curve.

Radiofrequency ablation (RFA) has gained popularity as treatment for Barrett's esophagus. Inclusive series of patients from initiation of our Barrett's Therapy Program were studied. Review of patients undergoing RFA for Barrett's was performed from September 2008 to May 2011. Patients' outcomes were recorded and analyzed using standard statistical methods. Seventy patients were treated. Average age was 61 (28-70); 80 per cent were male. Seventy-four per cent had dysplasia; 44 low-grade and eight high-grade. A total of 75.7 per cent of patients had long and 24.3 per cent had short segment Barrett's. Procedures per patient ranged from one to seven. Number of treatments in long- and short-segment groups were not different (P = 0.11). The maximum number of treatments in the short-segment group was five with a median of three (44.3%). For long segment, the maximum of RFA procedures was seven, with a median of three (30.8%). Average procedure time was 20.8 minutes for long and 17.9 minutes for short segment. Mean follow-up was 16.1 (2-38) months. Complete response was accomplished in 81 per cent. There were 93.3 per cent of complete responders in the short-segment group versus 75 per cent in the long (P = 0.24). Complications included dysphagia (1), transient chest and cervical pain (1), and abdominal pain (1). Comparing the first 25 per cent of the RFA procedures to the later 75 per cent or first 50 per cent to second 50 per cent, there was no difference in operative time or complications. Two patients recurred, both in the long-segment group. RFA is a safe and effective means to eradicate Barrett's. By measure of treatment time, complication rate, and efficacy of therapy, there is minimal or no "learning curve" for experienced endoscopists.

Colonoscopy is superior to neostigmine in the treatment of Ogilvie's syndrome.

BACKGROUND: Colonic pseudo-obstruction in critically ill patients may lead to devastating colonic perforation. Neostigmine is often the first-line intervention, because colonoscopy is more invasive and labor intensive. METHODS: A retrospective 10-year review at a tertiary medical center identified 100 patients with Ogilvie's syndrome, in whom treatment course and clinical and radiographic response were evaluated. RESULTS: Colonoscopy was significantly more successful than neostigmine (defined as no further therapy) after 1 or 2 interventions (75.0% vs 35.5%, P = .0002, and 84.6% vs 55.6%, P = .0031, respectively). One colonoscopy was more effective than 2 neostigmine administrations (75.0% vs 55.6%, P = .044). Clinical response (poor, fair, or good) was significantly better after colonoscopy than neostigmine after 1 or 2 interventions (P = .0028 and P = .00079). Cecal diameters decreased significantly more after colonoscopy than neostigmine (from 10.2 ± .5 cm to 7.1 ± .4 cm vs from 10.5 ± .5 cm to 8.8 ± .5 cm, P = .026). Neostigmine administration before colonoscopy did not affect outcomes. There were 3 perforations (3.7%): 1 each after colonoscopy, neostigmine, and no intervention. Neostigmine dose or repetition did not affect radiographic (P = .41) or clinical (P = .31) response. CONCLUSIONS: Colonoscopy is superior to neostigmine for Ogilvie's syndrome and should be considered first-line therapy, although neostigmine is useful in select patients and repeat interventions.