Doppler-guided hemorrhoidal dearterialization with laser (HeLP): indications and clinical outcome in the long-term. Results of a multicenter trial.

BACKGROUND: Doppler-guided hemorrhoidal laser procedure consists of sutureless closure of terminal branches of the superior hemorrhoidal artery by laser energy. Clinical results of patients treated with this procedure were analyzed at the completion of 2-year follow-up. Primary endpoint was resolution of symptoms and secondary endpoints were recurrence rate, type of recurrences, re-operation rate, and potential predictive factors for failure. METHODS: Bleeding was assessed on a score from 0 to 4 (none = 0; < 1/month = 1; 1/week = 2; > 1/week = 3; 3-4/week = 4), frequency of hemorrhoid-related symptoms with a score of 0-3 (2/year = 1; 3-5/year = 2; < 5/year = 3). Constipation and fecal incontinence were assessed by means of validated scores. Quality of life and pain at defecation were assessed using a visual analog scale of 0-10 (0 = worst possible-10 = best possible quality of life and 0 = no pain-10 = worst pain imaginable, respectively). Recurrence rate and need for re-operation were reported. Potential predictive factors of failure were analyzed by means of univariate analysis. RESULTS: Two-hundred-eighty-four patients (183 males, 101 females; mean age: 47.5 years) were included in the trial; 8 patients were lost at follow-up. Analysis of 276 patients who completed the 2-year follow-up showed an overall resolution of symptoms in 89.9% (248/276) of patients. Statistically significant improvement of quality of life, pain reduction, bleeding and frequency of acute symptoms were reported. Of 28 patients with persistent or recurrent symptoms, 12 had pain (4.35%), 10 had bleeding (3.6%) and 6 had increasing prolapse at defecation (2.2%). Eleven out of twenty-eight patients required additional surgery. Constipation and III-IV grade hemorrhoids were associated with statistically significant higher failure rates (p = 0.046 and 0.012, respectively). Better results were reported in patients reporting preoperative high-grade pain at evacuation. CONCLUSIONS: The Doppler-guided hemorrhoidal laser procedure showed efficacy at long-term follow-up. It can be considered as 'first-line' treatment in patients with low-grade hemorrhoids suffering from bleeding, pain and recurrent acute symptoms in whom conservative treatment failed.

Hemorrhoid laser procedure (HeLP) for second- and third-degree hemorrhoids: results from a long-term follow-up analysis.

We aimed to analyze the results of 5-year consecutive use of the hemorrhoidal laser procedure (HeLP) in patients with second- to third-grade hemorrhoids with minimal or moderate mucosal prolapse. A total of 189 patients were treated between April 2012 and October 2017. We reported perioperative complications, postoperative pain, improvement of hemorrhoids grade, and relapse of hemorrhoidal disease (HD). Improvement of symptoms was assessed using the Patient Global Improvement (PGI) Scale. No severe intraoperative complications were observed. The median follow-up was 42 months (range 6-62 months). Pain after surgery was absent in 94% of patients. No cases of rectal tenesmus or alterations of defecation habits were reported. Symptoms and HD improvement reached a "plateau" at 3 to 6 months following surgery. We observed a significant decrease in HD degree, occurrence of bleeding, pain, itching, and acute HD. Complete resolution of HD was reported in > 60% of patients 1 year after surgery. The individual level of improvement in symptoms was consistent (very much and much improved, according to PGI-I score) for about 90% of patients during the follow-up. This study confirmed that the HeLP is a safe, painless, and effective procedure for the treatment of HD in selected cases.

Financial and clinical implications of low-energy CT combined with 99m Technetium-sestamibi SPECT for primary hyperparathyroidism.

BACKGROUND: (99m)Technetium-sestamibi hybrid SPECT/CT has been favored over conventional SPECT in preoperative evaluation of primary hyperparathyroidism (PHPT) patients. However, the financial implications of CT-image acquisition have never before been published. This prompted us to perform a cost analysis of the aforementioned nuclear procedures. METHODS: A total of 55 PHPT patients operated on between 2004 and 2009 were studied. Overall, 27 patients underwent SPECT and 28 SPECT/CT. Localization results, as well as diagnostic and clinical cost variations between SPECT and SPECT/CT patients, were compared. RESULTS: SPECT/CT revealed higher sensitivity than SPECT (96.7 vs 79.3%; P = .011), as well as higher specificity (96.4 vs 82.4%; P = .037) and positive predictive value (PPV) (96.7 vs 83%; P = .038) for correctly identifying the neck-side affected by PHPT. Likewise, SPECT/CT disclosed higher sensitivity (86.7 vs 61.1%; P < .0001), specificity (97.4 vs 90%; P = .022), and PPV (86.7 vs 65.7%; P = .0001) for correct neck-quadrant identification. The mean operative time decreased from 62 min following SPECT to 36 min following SPECT/CT (P < .0001), yielding a mean surgical expense saving of 109.9 /patient (updated at 2009/2010 billing database). SPECT/CT actually ensures a mean expenditure reduction of 98.7 /patient (95% CI: 47.96 -149.42 ), diagnostic costs variation amounting to 11.2 /procedure. CONCLUSIONS: SPECT/CT ensures better focus for the surgical exploration, shortens surgical times, and eventually cuts costs when used for localization of parathyroid adenomas.

Effects of prophylactic ilioinguinal nerve excision in mesh groin hernia repair: short- and long-term follow-up of a randomized clinical trial.

We conducted a randomized clinical trial on the impact of prophylactic ilioinguinal nerve excision (INE) on neuralgia, hypoesthesia, and analgesia requirement after open herniorrhaphy as well as on sustainability of a selective approach. Ninety-seven consecutive patients undergoing a Lichtenstein procedure were treated with INE (n = 45) or preservation (NP) (n = 52). Impact of patients' age, gender, type of anesthesia, and hernia on outcomes was also evaluated by logistic regression analysis (LRA). Patients receiving INE reported less pain on postoperative days (POD) 1 and 7 and at 1 month and required less analgesia on POD 1. Overall younger patients (40 years old or younger) had more postoperative discomfort at LRA. Pain intensity was similar at 6 and 12 months after INE or NP: moderate to severe pain in 4.4 versus 11.5 per cent (P = 0.279) and 4.4 versus 9.6 per cent (P = 0.445), respectively. Hypoesthesia was more frequent after INE on POD 1 and 7:68.9 and 53.3 per cent versus 13.5 and 9.6 per cent, respectively (P < 0.0001), but no longer at 1 month: 11.1 versus 3.8 per cent (P = 0.244) as well as at 6 and 12 months (0% in both study groups). No further correlation was found by LRA. INE prevents inguinodynia up to 1 month follow-up regardless of patient variables. Moreover, the increase of hypoesthesia proved to be a short-term complication.

'Ad hoc' sternal-split safely replaces full sternotomy for thyroidectomy requiring thoracic access.

Mediastinal goiter (MG) removal occasionally needs sternotomy, mainly in case of subaortic extension. We aimed to test the hypothesis that sternal-split may safely replace full sternotomy for MG removal (through total thyroidectomy) when thoracic access is required. We conducted a prospective observational cohort study comparing 15 subaortic MGs receiving sternal-split with 87 MGs undergoing cervicotomy alone between January 1997 and June 2009. Among 15 cases requiring sternal incision, sternal-split was extended to the angle of Louis in nine patients (60%), to the third intercostal space (IS) in one of five (20%) cases of MGs with anterior mediastinum involvement, and in five of 10 (50%) cases with posterior involvement (P = 0.6). Full sternotomy was never necessary. The median hospitalization was 5 days (range, 4-8 days) after sternal access as compared with 3 days (range, 2-4 days) after cervicotomy (P = 0.04). Complications were similar in these two study groups: one postoperative bleeding in each group and three recurrent laryngeal nerve palsies after cervicotomy (P = 0.5). There was no operative mortality, blood transfusion, tracheotomy requirement, wound infection, or persistent hypoparathyroidism. Proper extension of sternal-split to the second or third IS allows an adequate approach to both the anterior and to the posterior mediastinum, thus permitting safe management of MGs requiring thoracic access.

Improvement of metabolic syndrome following intragastric balloon: 1 year follow-up analysis.

OBJECTIVE: This study aimed to assess the impact of intragastric balloon (IGB)-induced body weight loss on metabolic syndrome in obese patients and evaluate what happens during 1-year follow-up. METHODS: To this end, data were collected on 143 obese patients (body mass index (BMI) 36.2+/-5.7 kg/m2) who underwent IGB insertion between January 2000 and December 2005. Outcomes were recorded at BioEnterics Intragastric Balloon removal time (t0) and at 6-month (t6) and 12-month (t12) follow-up. RESULTS: Significant BMI, excess body weight loss percentage, and body weight loss percentage (BWL%) were observed at t0 (29.6+/-4.6 kg/m2; 29.3+/-4.8%; 14.1+/-5.7%), followed by partial weight regain at t12 (32.4+/-4.3 kg/m2; 26.1+/-4.9%; 11.2+/-4.6%). Incidence of metabolic syndrome dropped from 34.8% (pre-IGB value) to 14.5% (t0) and 11.6% (t12). Likewise, type 2 diabetes mellitus (DM), hypertriglyceridemia, hypercholesterolemia, and blood hypertension (BH) incidence decreased from 32.6%, 37.7%, 33.4%, and 44.9% (pre-IGB values) to 20.9%, 14.5%, 16.7%, and 30.4% at t0 and 21.3%, 17.4%, 18.9%, and 34.8% at t12. HbA1c blood concentration shifted from an initial value of 7.5+/-2.1% to 5.7+/-1.9% (t0), 5.6+/-0.7% (t6), and 5.5+/-0.9% (t12). Patients suffering from DM or BH stopped or diminished relative drug consumption at t12. Negligible modifications were reported as regards HDL cholesterol and hyperuricemia. CONCLUSION: Weight regain is commonly observed during long-term follow-up after IGB removal. Nevertheless, the maintenance of at least 10% of the BWL%, as reported at 1-year follow-up, is associated with an improvement in metabolic syndrome.

APACHE II, POSSUM, and ASA scores and the risk of perioperative complications in patients with colorectal disease.

OBJECTIVE: This study was designed to assess the role of the ASA, POSSUM and APACHE II score systems for predicting the complications in patients undergoing surgery for colorectal diseases. METHODS: We retrospectively analyzed 539 patients undergoing colorectal surgery between January 1996 and December 2006. The accuracy of ASA, POSSUM and APACHE II score systems for predicting perioperative complications has been analysed. RESULTS: Total postoperative morbidity was 15%, overall perioperative mortality was 1.5%. APACHE II and POSSUM predicted with the same accuracy the perioperative complications (0.65 and 0.68, respectively), while ASA score system revealed a poorer predicting accuracy (0.56). POSSUM predicted death rate more accurately compared to the APACHE II classification (1.6% vs. 10.4%). CONCLUSIONS: APACHE II and POSSUM score systems may be useful tools helping surgeons to identify patient groups at high risk for complications. The ASA classification resulted less accurate, probably because related to the anesthesiologist's knowledge.

[Our experience in selecting patients for bariatric surgery]. / La nostra esperienza nella selezione dei pazienti candidati alla chirurgia bariatrica.

AIM OF THE STUDY: To evaluate the parameters applied in Authors' experience for the selection of candidates undergoing bariatric surgery. MATERIALS AND METHODS: A retrospective analysis has been performed of 447 patients who underwent bariatric surgery from December 1998 to December 2006 at the 1st Service of General Surgery of Spedali Civili of Brescia - Abdominal Surgical Department of University of Study of Brescia; 317 patients underwent a mal-absorptive procedure, 35 a gastro-restrictive procedure and 10 had a conversion from a gastro-restrictive procedure to a mal-absorptive one. RESULTS: At 7 years of follow-up the Authors observed that the excess weight loss was 74.1% +/- 6.2 for mal-absorptive procedures and 42.3% +/- 2.6 for gastro-restrictive procedures. At 2 years of follow-up a progressive weight resumption was observed in the 20% of patients who had a gastro-restrictive procedures. DISCUSSION AND CONCLUSIONS: Optimal clinical outcome were achieved confirming the belief that a strict and rigorous selection of the patients and the applied therapeutic algorithm have to be followed; though even more selective criteria can be suggested such as the preventive BIB. The clinical results supported our preference of mal-absorptive procedures (317 of 352 surgical performances, excepting the 10 conversions with an obliged surgical choice).

Hemorrhoidal laser procedure: short- and long-term results from a prospective study.

BACKGROUND: We report the results of 2-year regular use of the hemorrhoidal laser procedure (HeLP) in 97 patients with symptomatic second- to third-grade hemorrhoids with minimal or moderate internal mucosal prolapse. METHODS: Data on duration of the procedure, perioperative complications, postoperative pain, downgrading of hemorrhoids, resolution or persistency, and recurrence of hemorrhoidal disease (HD) were prospectively collected. RESULTS: No significant intraoperative complications occurred. The median follow-up was 15 months. Postoperative pain was null in most patients. There were no cases of rectal tenesmus or alteration of defecation habits. Symptoms and HD downgrading reached a "plateau" at 3 to 6 months after the HeLP. At this evaluation, frequency of bleeding, pain, itching, and hemorrhoidal acute syndrome decreased by 76% to 79%. HD grade showed a significant reduction. HD recurrence rate was 5% at 2 years. CONCLUSIONS: Our study demonstrates that the HeLP is a safe, effective, and painless technique for the treatment of symptomatic second- to third-grade hemorrhoids with minimal or moderate mucosal prolapse, ideally suitable as ambulatory treatment.

Biliopancreatic diversion with transient gastroplasty and duodenal switch: long-term results of a multicentric study.

BACKGROUND: Over the years, several modifications of the Scopinaro biliopancreatic diversion (BPD) have been proposed. This retrospective study reported the results of 15 years of follow-up after open BPD coupled with a type of transient gastroplasty (TG) and duodenal switch (DS), termed BPD-TG with DS. METHODS: Data were analyzed for 874 patients operated on between January 1993 and May 2010 in 3 different surgical departments. RESULTS: The median preoperative body mass index (BMI) was 52 kg/m² (range, 35-63). Comorbidities present were hypertension (57%), hypercholesterolemia (87%), hypertriglyceridemia (53%), type 2 diabetes (35%), and obstructive sleep apnea syndrome (OSAS; 9%). The mean follow-up was 11.9 ± 3.1 years. The median BMI decreased to 33.9 after 1 year from bariatric surgery, 31.1 after 2-5 years, 30.9 after 5-10 years, and 31.2 kg/m² after 10-15 years. Overall, 67% of diabetic patients were able to stop insulin and 97% were able to stop oral hypoglycemic drugs within 1 year. Blood pressure, triglyceride levels, and cholesterol levels became normal in >96% of patients within 1 year. OSAS was resolved within 8 months in all cases. One year postoperatively, but absent thereafter, we observed severe hypoalbuminemia (serum albumin <3 g/dL) in 1.7% of patients and severe iron-deficiency anemia in 1.9%. Incisional hernias were recorded in 30% and anastomotic ulcers in 2.4% of cases. Mortality was null. CONCLUSION: Our results suggest considering BPD-TG with DS as a viable bariatric operation, with its excellent long-term outcome in terms of weight loss, improvement of obesity-related diseases, and quality of life.

Preoperative prediction of growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis modification and postoperative changes in candidates for bariatric surgery.

BACKGROUND: Several factors alter the growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis in obese patients, but GH/IGF-1 correlation with anthropometric parameters and lipid metabolism is still unclear. We evaluated this relationship and the postoperative axis modifications in candidates for bariatric surgery. METHODS: Eighty-eight patients (males/females (M/F), 34/54) scheduled for bariatric surgery (biliopancreatic diversion or laparoscopic-adjustable gastric banding) between 2008 and 2010 were included in this observational, open, prospective study. RESULTS: Preoperative serum GH concentrations were found near the lowest limit of normal range in both sexes, with males showing the lowest values (130 vs. 1,405 pg/ml; p < 0.01). Serum concentrations of IGF-1 were within the normal range (M/F, 179/168.5 ng/ml), whereas IGF-binding protein (BP)1 and 3 values were at the lowest limits of normal range in both sexes (M/F 1.8/3.1 µg/ml and M/F 4.1/4.2 µg/ml, respectively). A statistically significant inverse correlation was found between GH, IGF-1, and IGF-BP1-3 values and total cholesterol, LDL-cholesterol, and triglycerides values in both sexes. GH and IGF-BP1-3 values were also inversely related to waist circumference and waist/hip ratio (WHR). GH, IGF-1, and IGF-BP1 and 3 values (35 cases) increased 1 year postoperatively in both sexes, mainly after malabsorptive procedures. CONCLUSIONS: Our results support the hypothesis that GH deficiency associated with low levels of binding proteins in obese patients may be an endocrine response to visceral fat and high levels of non-esterified fatty acids, assessable in daily clinical practice by WHR, total and LDL-cholesterol, and triglycerides. In these patients, malabsorptive procedures might be the treatment of choice due to the metabolic adaptations induced.

Laparoscopy training in surgical education: the utility of incorporating a structured preclinical laparoscopy course into the traditional apprenticeship method.

OBJECTIVE: To investigate whether preclinical laparoscopy training offers a benefit over standard apprenticeship training and apprenticeship training in combination with simulation training. DESIGN: This randomized controlled trial consisted of 3 groups of first-year surgical registrars receiving a different teaching method in laparoscopic surgery. SETTING: The KU LEUVEN Faculty of Medicine is the largest medical faculty in Belgium. PARTICIPANTS: Thirty final-year medical students starting a general surgical career in the next academic year. METHODS: Thirty final-year medical students were randomized into 3 groups, which differed in the way they were exposed to laparoscopic simulation training but were comparable in regard to ambidexterity, sex, age, and laparoscopic psychomotoric skills. The control group received only clinical training during surgical residentship, whereas the interval group received clinical training in combination with simulation training. The registrars were allowed to do deliberate practice. The Centre for Surgical Technologies Preclinical Training Programme (CST PTP) group received a preclinical simulation course during the final year as medical students, but was not exposed to any extra simulation training during surgical residentship. At the beginning of surgical residentship and 6 months later, all subjects performed a standardized suturing task and a laparoscopic cholecystectomy in a POP Trainer. All procedures were recorded together with time and motion tracking parameters. All videos were scored by a blinded observer using global rating scales. RESULTS: At baseline the 3 groups were comparable. At 6 months, for suturing, the CST PTP group was better than both the other groups with respect to time, checklist, and amount of movements. The interval group was better than the control group on only the time and checklist score. For the cholecystectomy evaluation, there was a statistical difference between the CST PTP study group and both other groups on all evaluation scales in favor of the CST PTP group. CONCLUSIONS: Structured, preclinical proficiency-based training is better than clinical training combined with laboratory training or clinical training alone.

Predictive factors for postoperative severe hypocalcaemia after parathyroidectomy for primary hyperparathyroidism.

Hypocalcaemia is a complication of parathyroidectomy. We retrospectively analyzed data on patients who underwent parathyroidectomy for primary hyperparathyroidism (pHPT) to identify predictive factors for severe postoperative hypocalcaemia. Since 2004 we performed 87 parathyroidectomies for pHPT. We divided the patients into two groups: subjects who presented with postoperative hypocalcaemia (group B) or otherwise (group A). We looked for a correlation between several variables and the incidence of postoperative hypocalcaemia. The median calcemia in group B (19 patients) was 6.9 mg/dL on the first postoperative day and 7.6 mg/dL on the third day. We observed hypocalcemia related clinical symptoms in every patient. In all 19 cases the reduction of intraoperative parathyroid hormone above 85 per cent after parathyroidectomy was related to the development of severe postoperative hypocalcaemia (P = 0.042). We found that the reduction of intraoperative parathyroid hormone over 85 per cent after parathyroidectomy can be considered a reliable predictive factor of postoperative hypocalcaemia after parathyroidectomy for primary hyperparathyroidism.

High incidence of appendix carcinoid tumors among candidates for bariatric surgery: diagnostic and therapeutic implications.

Although the appendix has been recognized as a preferential site for carcinoid tumors in obese patients, no definitive guidelines are so far available regarding the management of these patients when candidates for bariatric surgery. This study was designed to fill that gap. Between 2000-2008, 558 patients underwent bariatric procedures. Appendectomy was routinely performed in 477 cases. Their charts were retrospectively retrieved and histopathology responses on surgical specimens were recorded. We aimed to assess: incidence of appendix carcinoid tumors (ACTs) and any possible risk-factor; modality of diagnosis (pre-, intra- or post-operatively); impact on the planned bariatric procedure; treatment reserved to such cases. Typical ACTs were diagnosed in 7 patients (1.4%) (median age: 33 years; median BMI: 49 kg/m²; males/females: 1/6). Four were diagnosed intra-operatively. Because of dimensions (<2 cm) and absence of mesoappendiceal or serosal involvement, simple appendectomy was performed during bariatric procedure, as planned. Three were diagnosed post-operatively (all <2 cm). In 1 case right hemicolectomy was performed 1 month later due to mesoappendiceal involvement. No appendectomy-related complication was encountered. All patients remained tumor-free during follow-up (mean: 64 months; range, 25-92). Young age, female sex, high BMI and diabetes mellitus resulted significantly associated with ACT. Our study sustains routine appendectomy or at least careful investigation of the appendix during bariatric surgery. For tumors <2 cm without mesoappendiceal or serosal involvement, simple appendectomy proved sufficient. Bariatric surgery did not have a negative effect on the treatment of malignancies that are discovered intra- or post-operatively.

Long-term results of biliopancreatic diversion with or without gastric preservation for morbid obesity.

We aimed at comparing our long-term results after biliopancreatic diversion (BPD) with or without gastric preservation for morbid obesity. Between 1999 and 2009, we performed 540 BPD: 287 patients (group A) underwent BPD with distal gastric resection (BPD-AHS) and 253 (group B) underwent BPD associated with transitory vertical gastroplasty (TGR) with duodenal switch (DS). The results have been analyzed in terms of weight loss, improvement of comorbidities, and quality of life (Bariatric Analysis and Reporting Outcome System). The mean follow-up was 7.4 ± 2.9 years. One year after surgery, mean initial excess weight loss percentage was 69% for patients in group A (n = 287) and 65% for group B (n = 253); after 2-5 years, it was 74% for patients who underwent BPD-AHS (n = 130) and 75% for patients who underwent BPD-TGR-DS (n = 116); it was 71% and 74% for patients in group A (n = 157) and B (n = 137), respectively, followed up for >5 years (P = 0.27). Among the diabetic patients in both groups (191 patients), 64% discontinued the medication with insulin (P = 0.25), and 98% had stopped oral drugs within 1 year from surgery (P = 0.29). We did not observe deficiencies of vitamins and proteins. The overall incidence of incisional hernias was 38% (P = 0.35). We recorded 13 anastomotic ulcers (2.4%; P = 0.28). BPD represents, in spite of the side effects, an effective technique for treatment of morbid obesity and its associated diseases. Moreover, our results showed that patients who underwent BPD-TGR-DS had slightly better results in terms of postoperative metabolic complications and improvement in quality of life.