Caffeine for intestinal transit after laparoscopic colectomy: randomized clinical trial (CaCo trial).

BACKGROUND: Coffee has been suggested to help postoperative gastrointestinal motility but the mechanism is not known. This trial assessed whether caffeine shortened time to bowel activity after laparoscopic colectomy. METHODS: This was a single-centre, randomized, double-blinded, placebo-controlled superiority trial (October 2015 to August 2020). Patients aged at least 18 years undergoing elective laparoscopic colectomy were assigned randomly to receive 100 mg or 200 mg caffeine, or a placebo (250 mg corn starch) three times a day orally. The primary endpoint was the time to first bowel movement. Secondary endpoints included colonic transit time, time to tolerance of solid food, duration of hospital stay, and perioperative morbidity. RESULTS: Sixty patients were assigned randomly to either the 200-mg caffeine group (20 patients), the 100-mg caffeine group (20) or the placebo group (20). In the intention-to-treat analysis, the mean(s.d.) time to first bowel movement was 67.9(19.2) h in the 200-mg caffeine group, 68.2(32.2) h in the 100-mg caffeine group, and 67.3(22.7) h in the placebo group (P = 0.887). The per-protocol analysis and measurement of colonic transit time confirmed no measurable difference with caffeine. CONCLUSION: Caffeine was not associated with reduced time to first bowel movement. REGISTRATION NUMBER: NCT02510911 (http://www.clinicaltrials.gov).

Advanced Lymph Node Staging With Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision for Rectal Cancer: A Retrospective Cohort Study.

BACKGROUND: Exact lymph node staging is essential in rectal cancer therapy. OBJECTIVE: The aim of the study was to assess the impact of intra-arterial indigo carmine injection after transanal total mesorectal excision on the number of retrieved lymph nodes. DESIGN: This was a retrospective, nonrandomized study. SETTINGS: The study was conducted at a tertiary hospital by a multidisciplinary team. PATIENTS: Patients who underwent transanal total mesorectal excision for suspected rectal cancer between 2013 and 2019 were included. INTERVENTIONS: Rectal cancer specimens received ex vivo intra-arterial indigo carmine injection to stain lymph nodes. MAIN OUTCOME MEASURES: Outcome measures included the number of retrieved lymph nodes with or without staining. RESULTS: Specimens of 189 patients were analyzed, of which 108 (57.1%) were stained with indigo carmine. A mean of 19.8 ± 6.1 lymph nodes was identified in stained samples compared to 16.0 ± 4.9 without staining ( p < 0.001). Multivariable analysis showed that 3.2 additional lymph nodes were found in stained specimens (95% CI: 1.0 to 5.3; p = 0.02). In stained specimens the adequate lymph node count (≥12) was increased in univariable (odds ratio: 3.24, 95% CI: 1.13 to 10.65; p = 0.03) but not in multivariable analysis. Indigo carmine injection had no effect on the number of positive lymph nodes or the nodal stage. Chemoradiotherapy reduced the lymph node count by 2.5 ( p = 0.008). After staining, 95.0% of patients with chemoradiotherapy had ≥12 lymph nodes retrieved. The median follow-up of patients was 24.2 months with a local recurrence rate of 3.3%. LIMITATIONS: The study is limited by its retrospective design and the nonrandomized allocation. CONCLUSIONS: Ex vivo intra-arterial indigo carmine injection increases the number of isolated lymph nodes after transanal total mesorectal excision regardless of neoadjuvant chemoradiotherapy. Indigo carmine injection is not associated with nodal upstaging or an increased number of tumor-positive lymph nodes. See Video Abstract at http://links.lww.com/DCR/B839 . ESTADIFICACIN AVANZADA DE LOS GANGLIOS LINFTICOS CON INYECCIN INTRAARTERIAL EX VIVO,DE NDIGO CARMN,DESPUS DE LA ESCISIN TOTAL DEL MESORRECTO POR VA TRANSANAL PARA CNCER DE RECTO UN ESTUDIO DE COHORTE RETROSPECTIVO: ANTECEDENTES:La estadificación exacta de los ganglios linfáticos es esencial en la tratamiento del cáncer de recto.OBJETIVO:El objetivo del estudio fue evaluar el impacto de la inyección intraarterial de índigo carmín después de la escisión total del mesorrecto por vía transanal con relación al número de ganglios linfáticos recuperados en el espécimen quirúrgico..DISEÑO:Estudio retrospectivo no aleatorizado.AJUSTE:El estudio se llevó a cabo en un hospital de tercer nivel por un equipo multidisciplinario.PACIENTES:Pacientes a quienes se les practicó escisión total del mesorrecto por vía transanal por sospecha de cáncer de recto entre 2013 y 2019.INTERVENCIONES:Al espécimen quirúrgico que se obtuvo, se le practicó inyección intraarterial ex vivo, de índigo carmín para teñir los ganglios linfáticos.PRINCIPALES MEDIDAS DE RESULTADO:El número de ganglios linfáticos recuperados con o sin tinción.RESULTADOS:Se analizaron muestras de 189 pacientes, de los cuales 108 (57,1%) fueron teñidos con índigo carmín. Se identificó una media de 19,8 ± 6,1 ganglios linfáticos en las muestras teñidas en comparación con 16,0 ± 4,9 sin tinción ( p < 0,001). El análisis multivariado mostró que se encontraron 3.2 ganglios linfáticos adicionales en las muestras teñidas (intervalo de confianza del 95%: 1,0 a 5,3; p = 0,02). En las muestras teñidas, el recuento adecuado de ganglios linfáticos (≥12) aumentó en el análisis univariado (razón de posibilidades: 3,24, intervalo de confianza del 95%: 1,13 a 10,65; p = 0,03) pero no en el multivariado. La inyección de índigo carmín no tuvo ningún efecto sobre el número de ganglios linfáticos positivos o el estadio ganglionar. La quimiorradioterapia redujo el recuento de ganglios linfáticos en 2,5 ( p = 0,008). Después de la tinción, en el 95,0% de los pacientes con quimiorradioterapia se recuperaron ≥12 ganglios linfáticos. La mediana de seguimiento de los pacientes fue de 24,2 meses con una tasa de recurrencia local del 3,3%.LIMITACIONES:El estudio está limitado por su diseño retrospectivo y la asignación no aleatoria.CONCLUSIONES:La inyección ex vivo de índigo carmín intraarterial aumenta el número de ganglios linfáticos aislados después de la escisión total del mesorrectal por vía transanal a pesar de la quimiorradioterapia neoadyuvante. La inyección de índigo carmín no se asocia con un aumento del estadio de los ganglios ni con un mayor número de ganglios linfáticos positivos para tumor. Consulte Video Resumen en http://links.lww.com/DCR/B839 . (Traducción-Eduardo Londoño-Schimmer ).

Effect of lymphadenectomy in curative gallbladder cancer treatment: a systematic review and meta-analysis.

PURPOSE: Only a small fraction of resectable gallbladder cancer (GBC) patients receive a thorough lymphadenectomy. The aim of this systematic review and meta-analysis was to investigate the effect of lymphadenectomy on survival in GBC surgery. METHODS: On May 19, 2019, MEDLINE, EMBASE, and the Cochrane Library were searched for English or German articles published since 2002. Studies assessing the effect of lymphadenectomy on survival in GBC surgery were included. Fixed effect and random effects models were used to summarise the hazard ratio (HR). RESULTS: Of the 530 identified articles, 18 observational studies (27,570 patients, 10 population-based, 8 cohort studies) were reviewed. In the meta-analysis, lymphadenectomy did not show a significant benefit for T1a tumours (n = 495; HR, 1.37; 95%CI, 0.65-2.86; P = 0.41). Lymphadenectomy showed a significant survival benefit in T1b (n = 1618; HR, 0.69; 95%CI, 0.50-0.94; P = 0.02) and T2 (n = 6204; HR, 0.68; 95%CI, 0.56-0.83; P < 0.01) tumours. Lymphadenectomy improved survival in the 2 studies assessing T3 tumours (n = 1961). A conclusive analysis was not possible for T4 tumours due to a low case load. Among patients undergoing lymphadenectomy, improved survival was observed in patients with a higher number of resected lymph nodes (HR, 0.57; 95%CI, 0.45-0.71; P < 0.01). CONCLUSIONS: Regional lymphadenectomy improves survival in T1b to T3 GBC. A minimum of 6 retrieved lymph nodes are necessary for adequate staging, indicating a thorough lymphadenectomy. Patients with T1a tumours should be evaluated for lymphadenectomy, especially if lymph node metastases are suspected.

Duodenal localization is a negative predictor of survival after small bowel adenocarcinoma resection: A population-based, propensity score-matched analysis.

BACKGROUND AND OBJECTIVES: This study assessed the influence of tumor localization of small bowel adenocarcinoma on survival after surgical resection. METHODS: Patients with resected small bowel adenocarcinoma, ACJJ stage I-III, were identified from the Surveillance, Epidemiology, and End Results database from 2004 to 2013. The impact of tumor localization on overall and cancer-specific survival was assessed using Cox proportional hazard regression models with and without risk-adjustment and propensity score methods. RESULTS: Adenocarcinoma was localized to the duodenum in 549 of 1025 patients (53.6%). There was no time trend for duodenal localization (P = 0.514). The 5-year cancer-specific survival rate was 48.2% (95%CI: 43.3-53.7%) for patients with duodenal carcinoma and 66.6% (95%CI: 61.6-72.1%) for patients with cancer located in the jejunum or ileum. Duodenal localization was associated with worse overall and cancer-specific survival in univariable (HR = 1.73; HR = 1.81, respectively; both P < 0.001), multivariable (HR = 1.52; HR = 1.65; both P < 0.001), and propensity score-adjusted analyses (HR = 1.33, P = 0.012; HR = 1.50, P = 0.002). Furthermore, young age, retrieval of more than 12 regional lymph nodes, less advanced stage, and married matrimonial status were positive, independent prognostic factors. CONCLUSIONS: Duodenal localization is an independent risk factor for poor survival after resection of adenocarcinoma.

Percutaneous tibial nerve stimulation (pTNS): success rate and the role of rectal capacity.

PURPOSE: Percutaneous tibial nerve stimulation (pTNS) was originally developed to treat urinary incontinence. Recently, some case series have also documented its success in the treatment of fecal incontinence. Nevertheless, the mechanism underlying this effect remains unknown but may be related to changes in rectal capacity. The aim of this study was to investigate the success of pTNS for the treatment of fecal urge incontinence and assess the influence of rectal capacity on treatment efficacy. METHODS: All patients undergoing pTNS for fecal incontinence between July 2009 and March 2014 were enrolled in a prospective, observational study consisting of a therapeutic regimen that lasted 9 months. Therapy success was defined as a reduction in the CCI (Cleveland Clinic incontinence) score of ≥50% and patient-reported success. Furthermore, quality of life (Rockwood's scale) and changes in anorectal physiology were recorded. RESULTS: Fifty-seven patients with fecal urge incontinence were eligible, nine of whom were excluded. The success rate was 72.5%. Incontinence events and urge symptoms were significantly reduced after 3 months and at the end of therapy. The median CCI score decreased from 12 to 4 (P < 0.0001), and the quality of life was significantly improved. However, rectal capacity was not significantly related to treatment success before or after therapy. No adverse events were observed. CONCLUSIONS: These results demonstrate that pTNS can improve the symptoms and quality of life of patients with fecal urge incontinence. However, the study fails to demonstrate a correlation between treatment success and changes in rectal capacity.

Efficacy of a Single Preoperative Dexamethasone Dose to Prevent Nausea and Vomiting After Thyroidectomy (the tPONV Study): A Randomized, Double-blind, Placebo-controlled Clinical Trial.

OBJECTIVE: Does dexamethasone given before thyroidectomy reduce postoperative nausea and vomiting (PONV) in a randomized controlled trial? BACKGROUND: PONV is an unsettling problem that commonly occurs in patients after thyroidectomy. Various preventive measures have been studied; however, many of these studies have been criticized for their biases (eg, use of opioids, sex selection) or were even retracted. METHODS: This single-institution, randomized, double-blind, placebo-controlled, superiority study was performed between January 1, 2011, and May 30, 2013. Patients undergoing thyroidectomy for benign disease were allocated by a block randomized list to receive a preoperative single dose of dexamethasone (8 mg) or placebo. Patients and staff were blinded to the treatment assignment. The primary endpoint was the incidence of PONV assessed at 4, 8, 16, 24, 32, and 48 hours after surgery. To observe an incidence reduction of 50%, a total of 152 patients were required for the study. RESULTS: The total incidence of PONV was reported in 65 of 152 patients (43%; 95% confidence interval [CI], 35-51). In the intention-to-treat analysis, PONV occurred in 22 of 76 patients (29%; 95% CI, 20-40) in the treatment arm and in 43 of 76 patients (57%; 95% CI, 45-67) in the control arm (P = 0.001; odds ratio = 0.31; 95% CI, 0.16-0.61; absolute risk reduction = 28%; 95% CI, 12-42). The number needed to treat was 4. No severe dexamethasone-related adverse events were observed during the study. CONCLUSIONS: A single dose of preoperative dexamethasone administration is an effective, safe, and economical measure to reduce PONV incidence after thyroidectomy.

Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718).

BACKGROUND: Inguinal hernia repair is one of the most common surgical procedures worldwide. This procedure is increasingly performed with endoscopic techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. The mesh must be fixed tightly, but without tension. During laparoscopic surgery, the mesh is generally fixed with staples or tissue glue. However, staples often cause pain at the staple sites, and they can cause scarring of the abdominal wall, which can lead to chronic pain. We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair. METHODS/DESIGN: The TISTA trial is a prospective, randomized, controlled, single-center trial with a two-by-two parallel design. All patients and outcome-assessors will be blinded to treatment allocations. For eligibility, patients must be male, ≥18 years old, and scheduled for laparoscopic repair of a primary inguinal hernia. One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples. The second group comprises patients with bilateral inguinal hernias. They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side. The primary endpoint will be pain under physical stress, measured at 24 h after surgery. Pain will be rated by the patient based on a numeric rating scale from 0 to 10, where 10 equals the worst pain imaginable. A total of 82 patients will be recruited (58 patients with unilateral inguinal hernias and 24 patients with bilateral hernias). This number is estimated to provide 90% power for detecting a pain reduction of one point on a numeric rating scale, with a standard deviation of one. DISCUSSION: Patients with bilateral hernias will receive two meshes, one fixed with glue, and the other fixed with staples. This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01641718.

Evaluation of sexual function in sexually active women 1 year after transvaginal NOTES: a prospective cohort study of 106 patients.

PURPOSE: The primary objective of this prospective cohort study was to investigate sexual function, quality of life and patient satisfaction in sexually active women 1 year after transvaginal hybrid natural orifice transluminal endoscopic surgery (NOTES). PATIENTS AND METHODS: This prospective single-centre cohort study included sexually active female patients after transvaginal hybrid NOTES cholecystectomy or anterior resection. Sexual life impairment and quality of life were assessed by the Gastrointestinal Quality of Life Index (GIQLI) prior and 1 year after surgery. Patient satisfaction was assessed as well as the sexual function 1 year postoperatively using the validated German version of the Female Sexual Function Index (FSFI-D). RESULTS: Between September 2008 and December 2009, 106 sexually active women after transvaginal hybrid NOTES cholecystectomy or anterior resection were identified. Sexual life significantly improved (GIQLI scores 3.2 ± 1.0 preoperatively vs. 3.7 ± 0.7 1 year postoperatively, P < 0.001), and painful sexual intercourse (3.3 ± 1.0 vs. 3.6 ± 0.7, P = 0.008) decreased post-surgery. The mean FSFI-D total score after transvaginal NOTES was 28.1 ± 4.6, exceeding the cutoff for sexual dysfunction defined as 26. Four (4.5 %) out of 88 patients who answered this question were not satisfied with the transvaginal hybrid NOTES procedure. CONCLUSIONS: This prospective cohort study of female sexual function after transvaginal NOTES provides compelling evidence that the transvaginal access is safe and associated with high satisfaction rate.

Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study.

BACKGROUND: Postoperative nausea and vomiting after general anesthesia is not only an unpleasant problem affecting 20-30% of surgical patients but may also lead to severe postoperative complications. There is a particularly high incidence of postoperative nausea and vomiting following thyroidectomy. Dexamethasone has been described as highly effective against chemotherapy-induced nausea and vomiting and has been proposed as a first-line method of postoperative nausea and vomiting prophylaxis. Despite this possible beneficial effect, the prophylactic administration of dexamethasone before surgery to prevent or ameliorate postoperative nausea and vomiting has not been established. A bilateral superficial cervical plexus block during thyroid surgery under general anesthesia significantly reduces pain. Of even greater clinical importance, this block prevents the need for postoperative opioids. Therefore, patients undergoing thyroidectomy and a bilateral superficial cervical plexus block are an ideal group to investigate the efficacy of dexamethasone for postoperative nausea and vomiting. These patients have a high incidence of postoperative nausea and vomiting and do not require opioids. They have no abdominal surgery, which can cause nausea and vomiting via a paralytic ileus. Combined with the highly standardized anesthesia protocol in use at our institution, this setting allows all known biases to be controlled. METHODS/DESIGN: We will perform a parallel two-arm, randomized (1:1), double-blind, placebo-controlled, single-center trial. Adults (≥18 years) scheduled for primary partial or total thyroidectomy because of a benign disease will be eligible for inclusion. The participants will be randomized to receive a single, intravenous preoperative dose of either 8 mg of dexamethasone in 2 ml saline (treatment group) or saline alone (placebo group). All the patients will receive a bilateral superficial cervical plexus block and standardized anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 152 patients will be recruited, providing 80% power to detect a 50% reduction in the incidence of postoperative nausea and vomiting. Any patients who require opioid treatment will be excluded from the per-protocol analysis. DISCUSSION: In the present protocol, we reduced bias to the greatest extent possible. Thus, we expect to definitively clarify the efficacy of dexamethasone for postoperative nausea and vomiting prophylaxis. TRIAL REGISTRATION: http://www.clinicaltrials.gov: NCT01189292.

Safe and early discharge after colorectal surgery due to C-reactive protein: a diagnostic meta-analysis of 1832 patients.

OBJECTIVE: To assess the predictive value of C-reactive protein (CRP) level for postoperative infectious complications after colorectal surgery. BACKGROUND: Postoperative infectious complications after colorectal surgery are frequent and associated with relevant short- and long-term sequelae. Therefore, the identification of a diagnostic tool for early recognition of postoperative infectious complications is of cardinal importance. METHODS: A meta-analysis was performed for diagnostic studies evaluating CRP as a predictor for postoperative infectious complications on days 1 to 5 after colorectal surgery. RESULTS: Six studies including a total of 1832 patients were identified. The best performance of CRP to predict postoperative infectious complications was on postoperative day 4, on which the mean CRP cutoff value was 135 mg/L (SD: 10 mg/L), the pooled sensitivity 68% (95% CI: 57%-79%), the specificity 83% (95% CI: 77%-90%) and the negative predictive value 89% (95% CI: 87%-92%). The pooled area under the receiver operating characteristic curve was 0.81 (95% CI: 0.73-0.89). CONCLUSIONS: This diagnostic meta-analysis of 1832 patients--the first in the literature--provides compelling evidence that C-reactive protein on postoperative day 4 has a high negative predictive value for infectious complications of 89%. Therefore, CRP measurement allows safe and early discharge of selected patients after colorectal surgery.

Diagnostic study and meta-analysis of C-reactive protein as a predictor of postoperative inflammatory complications after gastroesophageal cancer surgery.

PURPOSE: This study assessed the diagnostic accuracy of C-reactive protein (CRP) after gastroesophageal cancer resection for postoperative inflammatory complications (PIC). METHODS: The clinical data and CRP values of patients operated on for gastroesophageal cancer surgery between 1997 and 2009 were retrospectively analyzed. The results of this study were compared with published data using a meta-analytic approach for diagnostic outcomes. RESULTS: Of 210 patients included in the study, 59 developed PIC (28.1 %; 95 % CI: 22.5-34.5 %). On the postoperative day (POD) 4 and 7, CRP had the best diagnostic accuracy for PIC (AUC 0.77; 95 % CI, 0.64-0.91, AUC 0.81; 95 % CI, 0.71-0.91). Using a cut-off value of 141 mg/L (95 % CI, 131-278 mg/L) for CRP on POD 4, the sensitivity was 0.78 (95 % CI, 0.55-0.91), the specificity was 0.70 (95 % CI, 0.53-0.83) and the NPV was 0.89 (95 % CI, 0.77-0.95). The in-hospital mortality rate was 3.3 % (95 % CI, 1.5-6.9 %). In a diagnostic meta-analysis that included two additional studies, CRP had a significant predictive value after POD 3. CONCLUSION: There is limited evidence for the diagnostic accuracy of CRP levels for PIC after gastroesophageal cancer surgery. CRP levels on POD 4 might be useful to rule out PIC, but its diagnostic accuracy is moderate at best. For clinical routine use CRP levels are clearly not sufficient to predict PIC and have to be interpreted in the context of the whole clinical picture.

Impact of the new TNM Staging System (8th edition) on oral tongue cancers.

AIM OF THE STUDY: For tumours of the oral tongue, the most recent 8th edition of the AJCC/UICC staging system has introduced depth of infiltration (DOI) as a novel parameter. With this study we wanted to investigate its impact regarding this risk stratification compared with the preceding 7th edition. METHODS: Between 2008 and 2017, 161 patients of two tertiary referral centres in Switzerland (Kantonsspital St. Gallen and University Hospital Zurich) with T1 N0 or T2 N0 tongue cancers were enrolled in this study. The primary tumours were restaged according to the 8th edition of the TNM classification. Kaplan-Meier curves for overall and disease-specific survival were calculated. RESULTS: According to the 7th edition, of the 161 patients, 102 were staged after surgery as pT1 (stage I) and 59 as pT2 (stage II). According to the 8th edition, 36 patients (22.4%) were re-staged to a higher stage. Of these 36 patients, 8 (22.2%) experienced a recurrence, and 9 (25%) died. In the remaining, not re-staged group, 20 patients (16.0%) experienced a recurrence (p = 0.55) and 14 (11.2%) died (p = 0.025*). The 7th edition showed a statistically significant difference between pT1 and pT2 tumours for overall survival (p = 0.025), but not for disease-specific survival (p = 0.091), whereas the 8th edition was able to well discriminate between pT1, pT2 and pT3 for both overall (pT1 vs pT2, p = 0.016*; pT2 vs pT3, p = 0.031*) and disease-specific survival (pT1 vs pT2, p = 0.037*; pT2 vs pT3, p = 0.023*). CONCLUSION: The recent TNM 8th edition provides a more accurate prediction of overall and disease-specific survival for this subgroup of patients. Hence, a more aggressive treatment should be considered for patients re-staged to pT3 due to depth of infiltration.

Functional outcome and quality of life after stapled transanal rectal resection for obstructed defecation syndrome.

PURPOSE: Clinical studies have demonstrated that stapled transanal rectal resection with Contour Transtar (Transtar procedure) is a safe and effective treatment for patients with obstructive defecation syndrome. The aim of this study was to determine functional outcome and quality of life after the procedure. METHODS: Female patients with obstructive defecation syndrome were enrolled prospectively for the Transtar procedure. Intussusception and anterior rectocele were confirmed by clinical investigation and by magnetic resonance defecography. Functional outcome was measured by obstructed defecation syndrome score, severity of symptoms score, and Wexner score preoperatively and postoperatively. Quality of life was assessed by the Cleveland Clinic constipation score, the fecal incontinence quality of life scale, and the SF-36v2 health survey. RESULTS: Between January 2007 and November 2008, 52 consecutive patients (median age: 64 years) were included in the study. Before the surgery, 12 patients experienced fecal incontinence. Functional scores improved significantly: 6 weeks after surgery, the obstructed defecation syndrome score decreased from a median of 16 (range, 9-22) to 5 (range, 2-10) and the severity of symptoms score, from 16 (range, 9-21) to 4 (range, 0-9) (each P < .0001). After 6 weeks, 10 patients had fecal incontinence and 12 patients experienced fecal urgency. At 3 months, 6 patients were still incontinent, 3 of whom were treated successfully with sacral neuromodulation. Fecal urgency resolved in all cases after 6 months. Quality of life improved, particularly in the mental components. CONCLUSION: Despite the described postoperative symptoms, most of which can be treated conservatively, the Transtar procedure is an effective treatment for patients with obstructive defecation syndrome and improves quality of life significantly.

Functional outcome after perineal stapled prolapse resection for external rectal prolapse.

BACKGROUND: A new surgical technique, the Perineal Stapled Prolapse resection (PSP) for external rectal prolapse was introduced in a feasibility study in 2008. This study now presents the first results of a larger patient group with functional outcome in a mid-term follow-up. METHODS: From December 2007 to April 2009 PSP was performed by the same surgeon team on patients with external rectal prolapse. The prolapse was completely pulled out and then axially cut open with a linear stapler at three and nine o'clock in lithotomy position. Finally, the prolapse was resected stepwise with the curved Contour Transtar stapler at the prolapse's uptake. Perioperative morbidity and functional outcome were prospectively measured by appropriate scores. RESULTS: 32 patients participated in the study; median age was 80 years (range 26-93). No intraoperative complications and 6.3% minor postoperative complications occurred. Median operation time was 30 minutes (15-65), hospital stay 5 days (2-19). Functional outcome data were available in 31 of the patients after a median follow-up of 6 months (4-22). Preoperative severe faecal incontinence disappeared postoperatively in 90% of patients with a reduction of the median Wexner score from 16 (4-20) to 1 (0-14) (P < 0.0001). No new incidence of constipation was reported. CONCLUSIONS: The PSP is an elegant, fast and safe procedure, with good functional results. TRIAL REGISTRATION: ISRCTN68491191.

Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol.

INTRODUCTION: Incontinence (up to 20%) and erectile dysfunction (up to 70%) occur frequently after radical prostatectomy (RP) in patients with localized prostate cancer. Human amniotic membrane (HAM) can improve tissue regeneration and functional outcome after RP owing to the growth factors and unique immune tolerance. Preliminary studies showed the potential value of HAM in the reconstruction of the urinary tract and nerve protection during RP. METHODS: A protocol is developed for a prospective, randomized, single-blind, single-surgeon, placebo-controlled exploration study of the efficacy and safety of dehydrated human amnion membrane placed around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RP for the treatment of localized prostate cancer. Eligible for inclusion are patients with localized prostate cancer, requiring a surgical procedure and exclusion of preoperative incontinence and erectile dysfunction. The patients are randomized 1:1 to HAM vs. placebo and blinded during the study period. According to the T test with an alpha of 0.05 and a power of 80% and expecting a dropout of 20% of the patients, an adjusted sample size per arm of 164 patients is required. PLANNED OUTCOMES: The primary outcome is a postoperative continence measured as 24-h pad test up to 12 months postoperatively. Secondary outcomes are potency, time of postoperative catheter removal, postoperative complications, and biochemical recurrence. The protocol for this randomized exploration study defines the conditions to assess the efficacy and safety of HAM application during RP in order to improve the postoperative functional outcome. This trial should pave the way for future studies of tissue engineering in an effort to reduce the morbidity of RP. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT03864939.

Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study.

BACKGROUND/AIMS: The aim of this study was to evaluate the sustainability of sacral neuromodulation (SNM) success in patients with fecal incontinence (FI) and/or constipation. METHODS: This is a retrospective analysis of a prospective database of patients who received SNM therapy for FI and/or constipation between 2006 and 2015. Success rates, complications and reintervention rates were assessed after up to 10 years of follow-up. RESULTS: Electrodes for test stimulation were implanted in 101 patients, of whom 79 (78.2%) received permanent stimulation. The mean follow-up was 4.4 ± 3.0 years. At the end of follow-up, 57 patients (72.2%) were still receiving SNM. The 5-year success rate for FI and isolated constipation was 88.2% (95% confidence interval [CI], 80.1-97.0%) and 31.2% (95% CI, 10.2-95.5%), respectively (P ＜ 0.001). In patients with FI, involuntary evacuations per week decreased ＞ 50% in 76.1% of patients (95% CI, 67.6-86.2%) after 5 years. A lead position at S3 was associated with an improved outcome (P = 0.04). Battery exchange was necessary in 23 patients (29.1%), with a median battery life of 6.2 years. Reinterventions due to complications were necessary in 24 patients (30.4%). For these patients, the 5-year success rate was 89.0% (95% CI, 75.3-100.0%) compared to 78.4% (95% CI, 67.2-91.4%) for patients without reintervention. CONCLUSIONS: SNM offers an effective sustainable treatment for FI. For constipation, lasting success of SNM is limited and is thus not recommended. Reinterventions are necessary but do not impede treatment success.

Neoadjuvant therapy of gastric cancer with the human monoclonal IgM antibody SC-1: impact on the immune system.

Adjuvant therapies for minimal residual disease are a promising approach to improve the poor survival rates after surgery of gastric tumors. A pilot study of a neoadjuvant therapy was performed using a human monoclonal IgM antibody (SC-1) specifically inducing apoptosis in signet ring cell stomach carcinomas. However, scarce information exists on how such a treatment affects the immune system, in particular what are the effects of apoptosis induction and infusion of large amounts of IgM. Thus, the leukocyte composition (CD3, CD4, CD8, CD19, CD16+56, CD14) and several cytokines (TNF-alpha, IL6, IL12, IFN-gamma, GM-CSF, Neopterin) before and after SC-1 application were measured and compared to results of patients that underwent surgical removal of gastric carcinoma without antibody treatment. After SC-1 application, an increase in TNF-alpha and a decrease of lymphocytes and CD3+ T-cells but in the range obtained in healthy individuals was observed before surgery. After surgery, the IL6 levels increased and the TNF-alpha levels remained at the elevated level. Furthermore, there was a significant drop in lymphocytes and CD3+ T-cells. These effects were due to the surgical treatment. Other parameters did not show significant changes. It seems that the application of an apoptosis-inducing antibody prior to surgery of gastric tumors has mild if any effect on the immune system. Therefore, from an immunological point of view, the treatment with this monoclonal antibody is extremely safe.

The More the Better-Lower Rate of Stage Migration and Better Survival in Patients With Retrieval of 20 or More Regional Lymph Nodes in Pancreatic Cancer: A Population-Based Propensity Score Matched and Trend SEER Analysis.

OBJECTIVE: The aim of this study was to assess the influence of regional lymph node (RLN) retrieval on stage migration and survival in pancreatic cancer. METHODS: A total of 7685 stage I and II pancreatic cancer patients were identified in the Surveillance, Epidemiology, and End Results database in 2004-2011. The impact of RLN was assessed using Cox regression, propensity score methods, and joinpoint regression. RESULTS: In 3079 patients, 1 to 10 RLNs were retrieved; in 2799 patients, 11 to 19 RLNs, and in 1807 patients, 20+ RLNs. The rate of node-positive pancreatic cancer increased with the number of retrieved RLN. This trend continued beyond 10 retrieved RLN (P < 0.001). In unadjusted analysis, retrieval of RLN did not influence survival (P = 0.178). When adjusting for significant bias in staging variables (P < 0.001), retrieval of 20+ RLNs compared to 11 to 19 RLNs was associated with an increased survival in node-negative (hazard ratio, 0.78; 95% confidence interval, 0.62-0.98; P = 0.033) and node-positive cancer (hazard ratio, 0.83; 95% confidence interval, 0.74-0.93; P = 0.002). CONCLUSIONS: This population-based propensity score-adjusted investigation demonstrated that more retrieved RLNs in pancreatic cancer decreases the rate of stage migration and improves the oncological outcome in node-negative and positive cancer. Contradictory results may be explained by a bias in the cancer characteristics for a different extent of RLN retrieval.

Patients with Adenocarcinoma of the Small Intestine with 9 or More Regional Lymph Nodes Retrieved Have a Higher Rate of Positive Lymph Nodes and Improved Survival.

PURPOSE: To assess the influence of regional lymph node (RLN) retrieval on stage migration of adenocarcinoma of the small intestine and survival. PATIENTS AND METHODS: From the Surveillance, Epidemiology, and End Results database,1090 patients with nonmetastatic small bowel adenocarcinoma were identified in between 2004 and 2011. The impact of the number of RLNs removed on histopathological staging and oncological outcome was assessed utilizing Cox proportional hazard regression models with and without risk-adjustment, propensity score methods, and joinpoint regression analysis. RESULTS: The rate of node-positive cancer increased steadily with the number of retrieved RLNs up to 9 RLNs, which suggests that a minimum of 9 (95 % CI 5.5­10.5) retrieved RLNs are needed for the detection of node-positive disease (P < 0.001). From 657 of 1090 patients (60.3 %), 9 or more RLNs were retrieved. While in 2004 only in 46.0 % of all cases 9+ RLNs were retrieved, this rate increased to 69.3 % in 2011 (P < 0.001). The multivariable analysis demonstrated that the retrieval of 9+ RLNs was associated with better overall (hazard ratio of death [HR] = 0.67, 95 % CI 0.55­0.82, P < 0.001) and cancer-specific survival (HR = 0.77, 95 % CI 0.61­0.96, P = 0.022). This finding was confirmed by a propensity score-adjusted analysis, which indicated increased overall (HR = 0.67, 95 % CI 0.50­0.89, P < 0.001) and cancer-specific survival (HR = 0.67, 95 % CI 0.49­0.92, P = 0.013) in patients with the retrieval of 9+ RLNs. CONCLUSION: To our knowledge, this is the first population-based propensity score-adjusted investigation in small bowel adenocarcinoma. A sufficient number of RLNs should be retrieved to achieve an optimal oncological outcome