Sacral nerve stimulation in patients with ileal pouch-anal anastomosis.

PURPOSE: Functional results after proctocolectomy and ileal pouch-anal anastomosis (IPAA) are generally good. However, some patients suffer from high stool frequency or fecal incontinence. Sacral nerve stimulation (SNS) may represent a therapeutic alternative in these patients, but little is known about indication and results. The aim of this study was to evaluate incontinence after IPAA and demonstrate SNS feasibility in these patients. METHODS: This retrospective study includes patients who received a SNS between 1993 and 2020 for increased stool frequency or fecal incontinence after proctocolectomy with IPAA for ulcerative colitis. Proctocolectomy was performed in a two- or three-step approach with ileostomy closure as the last step. Demographic, follow-up data and functional results were obtained from the hospital database. RESULTS: SNS was performed in 23 patients. Median follow-up time after SNS was 6.5 years (min. 4.2-max. 8.8). Two patients were lost to follow-up. The median time from ileostomy closure to SNS implantation was 6 years (min. 0.5-max. 14.5). Continence after SNS improved in 16 patients (69%) with a median St. Marks score for anal incontinence of 19 (min. 4-max. 22) before SNS compared to 4 (0-10) after SNS placement (p = 0.012). In seven patients, SNS therapy was not successful. CONCLUSION: SNS implantation improves symptoms in over two-thirds of patients suffering from high stool frequency or fecal incontinence after proctocolectomy with IPAA. Awareness of the beneficial effects of SNS should be increased in physicians involved in the management of these patients.

Stapled intestinal anastomoses are more cost effective than hand-sewn anastomoses in a diagnosis related group system.

PURPOSE: Creation of an optimal bowel anastomosis with low postoperative leakage rate is an immanent part of colorectal surgery contributing to recovery, length of hospital stay and overall hospital costs. We aimed to investigate costs of small and large bowel resection, length of hospital stay, anastomotic leakage rate and its risk factors depending on the anastomotic technique. METHODS: Retrospective analysis of 198 patients (67 stapled and 131 hand-sewn anastomoses) undergoing elective bowel resection with a single anastomosis without protective ileostomy either stapled or in double-rowed running suture technique between 1st October 2012 and 30th September 2018 at Charité University Hospital Berlin, Campus Benjamin Franklin. We analyzed costs of treatment, total length of hospital stay, rate of anastomotic leakage and possible risk factors for anastomotic leak. RESULTS: No significant difference between both anastomotic techniques could be detected for hospital stay (p = 0.754), 30-day-readmission rate (p = 0.827), or anastomotic leakage (p = 606). Neither comorbidities (p = 0.449), underlying disease (p = 0.132), experience of the surgical team (p = 0.828) nor scheduling of the operation (p = 0.531) were associated with anastomotic leakage. Stapled anastomoses took 22 min less operation time than sutured anastomoses (130 vs. 152 min. Median) (p = 0.001). Operations with stapled anastomoses saved 183 € in operation costs and 496 € in overall hospital costs. CONCLUSION: Stapled and hand-sewn bowel anastomoses can be performed equally safe without differences in postoperative outcome. No patient, procedure or surgeon related risk factors for anastomotic leakage could be detected. Bowel resections with stapled anastomoses take less time and save operation and overall hospital costs.

Novel methods for in vitro modeling of pancreatic cancer reveal important aspects for successful primary cell culture.

BACKGROUND: Pancreatic cancer remains a fatal disease. Experimental systems are needed for personalized treatment strategies, drug testing and to further understand tumor biology. Cell cultures can serve as an excellent preclinical platform, but their generation remains challenging. METHODS: Tumor cells from surgically removed pancreatic ductal adenocarcinoma (PDAC) specimens were cultured under novel protocols. Cellular growth and composition were analyzed and culture conditions were continuously optimized. Characterization of cell cultures and primary tumors was performed via hematoxylin and eosin (HE) and immunofluorescence (IF) staining. RESULTS: Protocols for two- and three-dimensional PDAC primary cell cultures could successfully be established. Primary cell culture depended on dissociation techniques, growth factor supplementation and extracellular matrix components containing Matrigel being crucial for the transformation to three-dimensional PDAC organoids. The generated cultures showed to be highly resemblant to established PDAC primary cell cultures. HE and IF staining for cell culture and corresponding primary tumor characterization could successfully be performed. CONCLUSIONS: The work presented herein shows novel and effective methods to successfully establish primary PDAC cell cultures in a distinct time frame. Factors contributing to cell growth and differentiation could be identified with important implications for further primary cell culture protocols. The established protocols might serve as novel tools in personalized tumor therapy.

Colectomy with ileostomy for severe ulcerative colitis-postoperative complications and risk factors.

PURPOSE: In the era of biological therapy of ulcerative colitis (UC), surgical treatment frequently consists of colectomy, end ileostomy, and rectal stump closure before patients go on towards restorative proctocolectomy. We aimed to evaluate possible risk factors for the occurrence of postoperative complications and investigate those after initial colectomy in these patients. METHODS: Retrospective analysis of 180 patients (76 female, 104 male) undergoing colectomy for UC with formation of a rectal stump and terminal ileostomy between March 2008 and March 2018 at Charité University Hospital Berlin, Campus Benjamin Franklin. A panel of possible postoperative complications was established, patient history was screened, and postoperative complications were analyzed using the Clavien Dindo Classification. RESULTS: Postoperative complication rate was 27.7%. Mortality was 0.5%. Postoperative ileus occurred in 15.3% and rectal stump leakage in 14.8%. Complications were categorized as Clavien Dindo 3 in 80%. Risk factors for surgical complications after multivariate analysis were ASA classification (p = 0.004), preoperative anemia (Hemoglobin < 8 mg/dl) (p = 0.025), use of immunosuppressants (p = 0.003), more than two cardiovascular diseases (p = 0.016), and peritonitis (p = 0.000). Reoperation rate of patients with surgical complications was 27.7%. CONCLUSION: Colectomy in high-risk UC patients is associated with significant morbidity. However, most of the surgical complications can be treated conservatively. Overall mortality is low. Patient-related risk factors are associated with postoperative complications. Optimizing these risk factors or earlier indication for surgery in the course of UC may help to reduce morbidity of this procedure.

The adipofasciocutaneous gluteal fold perforator flap a versatile alternative choice for covering perineal defects.

AIM: Perineal defects following the resection of anorectal malignancies are a reconstructive challenge. Flaps based on the rectus abdominis muscle have several drawbacks. Regional perforator flaps may be a suitable alternative. We present our experience of using the gluteal fold flap (GFF) for reconstructing perineal and pelvic defects. METHODS: We used a retrospective chart review and follow-up examinations focusing on epidemiological, oncological (procedure and outcome), and therapy-related data. This included postoperative complications and their management, length of hospital stay, and time to heal. RESULTS: Twenty-two GFFs (unilateral n = 8; bilateral n = 7) were performed in 15 patients (nine women and six men; anal squamous cell carcinoma n = 8; rectal adenocarcinoma n = 7; mean age 65.5 + 8.2 years) with a mean follow-up time of 1 year. Of the cases, 73.3% were a recurrent disease. Microscopic tumor resection was achieved in all but one case (93.3%). Seven cases had no complications (46.7%). Surgical complications were classified according to the Clavien-Dindo system (grades I n = 2; II n = 2; IIIb n = 4). These were mainly wound healing disorders that did not affect mobilization or discharge. The time to discharge was 22 + 9.9 days. The oncological outcomes were as follows: 53.3% of the patients had no evidence of disease, 20% had metastatic disease, 20% had local recurrent disease, and one patient (6.7%) died of other causes. CONCLUSIONS: The GFF is a robust, reliable flap suitable for perineal and pelvic reconstruction. It can be raised quickly and easily, has an acceptable complication rate and donor site morbidity, and does not affect the abdominal wall.

Oncological outcome after MRI-based selection for neoadjuvant chemoradiotherapy in the OCUM Rectal Cancer Trial.

BACKGROUND: It is not clear whether all patients with rectal cancer need chemoradiotherapy. A restrictive use of neoadjuvant chemoradiotherapy (nCRT) based on MRI findings for rectal cancer was investigated in this study. METHODS: This prospective multicentre observational study included patients with stage cT2-4 rectal cancer, with any cN and cM0 status. Carcinomas in the middle and lower third that were 1 mm or less from the mesorectal fascia, all cT4 tumours, and all cT3 tumours of the lower third were classified as high risk, and these patients received nCRT followed by total mesorectal excision (TME). All other carcinomas with a minimum distance of more than 1 mm from the mesorectal fascia and those in the upper third were classified as low risk; these patients underwent TME alone (no nCRT). Patients were followed for at least 3 years. Outcomes were the rates of local recurrence, distant metastasis and survival. RESULTS: Among 545 patients included, 428 were treated according to the study protocol: 254 (59·3 per cent) had TME alone and 174 (40·7 per cent) received nCRT and TME. Median follow-up was 60 months. The 3- and 5-year local recurrence rates were 1·3 and 2·7 per cent respectively, with no differences between the two treatment protocols. Patients with disease requiring nCRT had higher 3- and 5-year rates of distant metastasis (17·3 and 24·9 per cent respectively versus 8·9 and 14·4 per cent in patients who had TME alone; P = 0·005) and worse disease-free survival compared with that in patients who did not need nCRT (3- and 5-year rates 76·7 and 66·7 per cent, versus 84·9 and 76·0 per cent in the TME-alone group; P = 0·016). CONCLUSION: Restriction of nCRT to high-risk patients achieved good results.

Influence of pelvic volume on surgical outcome after low anterior resection for rectal cancer.

BACKGROUND: Low anterior resection (LAR) for rectal cancer is a potentially challenging operation due to limited space in the pelvis. CT pelvimetry allows to quantify pelvic space, so that its relationship with outcome after LAR may be assessed. Studies investigating this, however, yielded conflicting results. We hypothesized that a small pelvis is associated with a higher rate of incomplete mesorectal excision, anastomotic leakages, and increased rate of urinary dysfunction in patients operated for rectal cancer. METHODS: In a single-center retrospective analysis, we studied 74 patients that underwent LAR for rectal cancer with primary anastomosis. Thin-layered multi-slice CT datasets were used for slice by slice depiction of the inner pelvic surface, and the inner pelvic volume was automatically compounded. The primary outcome was quality of total mesorectal excision (TME; Mercury grading); secondary outcomes were anastomotic leakage and urinary dysfunction with regard to pelvic dimensions. Univariate analyses and multiple logistic regression analyses were performed for the primary and the secondary outcomes. RESULTS: Shorter obstetric conjugate diameters were associated with a higher probability of a worse TME quality (110.8 ± 10.2 vs. 105.0 ± 8.6 mm; OR 0.85; 95% CI 0.73-0.99; p = 0.038). Short interspinous distance showed a trend towards an increased risk for deteriorated TME quality (OR 0.88; 95% CI 0.76-1.0; p = 0.06). Anastomotic leakage was associated with anemia (OR 2.77; 95% CI 1.0-7.7; p = 0.047). Association between pelvic diameters or pelvic volume and anastomotic leakage or urinary dysfunction was not observed. Perioperative blood transfusions were administered more often in patients with postoperative urinary dysfunction (OR 17.67; 95% CI 2.44-127.7; p = 0.004). CONCLUSION: Shorter obstetric conjugate diameter might be a risk factor for incompleteness of total mesorectal excision. Anastomotic leakage seems to be influenced more by clinical factors such as anemia rather than pelvic dimensions. Further studies have to prove the influence of pelvic diameter on local recurrence of rectal cancer after LAR.

Necessity of subcutaneous suction drains in ileostomy reversal (DRASTAR)-a randomized, controlled bi-centered trial.

PURPOSE: Data regarding length of hospital stay of patients undergoing ileostomy reversal are very heterogeneous. There are many factors that may have an influence on the length of postoperative hospital stay, such as postoperative wound infections. One potential strategy to reduce their incidence and to decrease hospital stay is to insert subcutaneous suction drains. The purpose of this study was to examine the influence of the insertion of subcutaneous suction drains on hospital stay and postoperative wound infections in ileostomy reversal. Risk factors for postoperative wound infection were determined. METHODS: This is a randomized controlled two-center non-inferiority trial with two parallel groups. The total length of hospital stay as primary endpoint and the occurrence of a surgical site infection, the colonization of the abdominal wall with bacteria, and the occurrence of hematomas/seromas as secondary endpoints were monitored. RESULTS: One hundred eighteen patients with elective ileostomy reversal were included. Fifty-nine patients were randomly assigned to insertion of a subcutaneous suction drain, and 59 patients were randomly assigned to receive no drain. After 3 months of follow-up, 50 patients in the group with drain and 53 patients in the group without drain could be analyzed. Median total length of hospital stay was 8 days in the SD group and 9 days in the group without SD (p = 0.17). Fourteen percent of patients with SD and 17 % without SD developed SSI, p = 0.68. Multivariate analysis revealed anemia (p < 0.01), intraoperative bowel perforation (p = 0.02) and resident (p = 0.04) or fellow (p = 0.048) performing the operation as risk factors for SSI. CONCLUSIONS: This trial shows that the omission of subcutaneous suction drains is not inferior to the use of subcutaneous suction drains after ileostomy reversal in terms of length of hospital stay, surgical site infections, and hematomas/seromas.

Impact of intraoperative microperfusion assessment with Pinpoint Perfusion Imaging on surgical management of laparoscopic low rectal and anorectal anastomoses.

AIM: Inadequate intestinal blood flow may contribute to anastomotic leakage accounting for substantial morbidity and mortality in colorectal surgery. Precise intraoperative assessment of microperfusion may have an impact on the surgeons intraoperative management and leakage rate. METHOD: In this single center observational study we implemented and integrated intraoperative indocyanin green (ICG) based microperfusion assessment of anastomosis with Pinpoint Perfusion Imaging in a series of consecutive rectal cancer patients who underwent laparoscopic anterior and lower anterior resection with primary anastomosis during a 5-months period. RESULTS: We could demonstrate the feasibility and safety of intraoperative fluorescence angiography for colorectal microperfusion assessment. Technology implementation was immediately successful. No adverse effects have been documented related to fluorescent dye. Microperfusion angiography of the colon succeeded in all cases and assessment of perfusion imaging influenced surgical decision making in 28% of the patients, of which all patients showed primary healing of the anastomosis. We found a leakage rate of 6% with one leakage of a coloanal anastomosis in all patients. CONCLUSION: Fluorescence angiography is an accurate tool for assessing microperfusion and is most likely associated with improved outcomes with regard to anastomotic healing.

The CR-POSSUM Risk Calculator Predicts Failure of Enhanced Recovery after Colorectal Surgery.

AIMS: To determine predictors of failed enhanced recovery after surgery (ERAS) in patients after elective colorectal surgery. METHODS: A cohort of 55 patients undergoing elective colorectal surgery was monitored prospectively. Perioperative care was based on a previously established protocol for ERAS. Pre-, intra-, and postoperative parameters were analyzed to elicit predictors of ERAS failure. ERAS failure was defined as prolonged hospital stay (> 7 days). The risk calculator CR-POSSUM was evaluated for its clinical utility. RESULTS: Body mass index (BMI) or the American Society of Anesthesiologists score (ASA) was not associated with ERAS failure on univariate analysis, but patients that failed ERAS were significantly older (64 y vs 54 y; p = 0.023). Prolonged length of stay (>7 days) was also associated with an open approach (p = 0.009), intraoperative nasogastric tube placement (p = 0.005), blood loss > 500 ml (p = 0.008), stoma formation (p = 0.006) and insertion of more than one intraabdominal drain during surgery (p = 0.005). Postoperative continuation of intravenous fluids (p = 0.027), reinsertion of urinary catheter (p = 0.045) and postoperative ileus (p = 0.020) were also strongly associated with delayed discharge on univariate analysis. After multivariate analysis the preoperative parameters CR-POSSUM score (p = 0.022), increasing BMI (p = 0.014) and preoperative albumin level (p = 0.031) were all independently associated with failure of ERAS. CONCLUSIONS: A variety of perioperative factors contribute to failure of ERAS in routine practice. CR-POSSUM can help to identify patients at risk for possible failure of ERAS. This may help to optimize avoidable factors, or accommodate those patients likely to require a longer post-operative stay.

The CR-POSSUM Risk Calculator Predicts Failure of Enhanced Recovery after Colorectal Surgery.

AIMS: To determine predictors of failed enhanced recovery after surgery (ERAS) in patients after elective colorectal surgery. METHODS: A cohort of 55 patients undergoing elective colorectal surgery was monitored prospectively. Perioperative care was based on a previously established protocol for ERAS. Pre-, intra-, and postoperative parameters were analyzed to elicit predictors of ERAS failure. ERAS failure was defined as prolonged hospital stay (> 7 days). The risk calculator CR-POSSUM was evaluated for its clinical utility. RESULTS: Body mass index (BMI) or the American Society of Anesthesiologists score (ASA) was not associated with ERAS failure on univariate analysis, but patients that failed ERAS were significantly older (64 y vs 54 y ; p = 0.023). Prolonged length of stay (> 7 days) was also associated with an open approach (p = 0.009), intraoperative nasogastric tube placement (p = 0.005), blood loss > 500 ml (p = 0.008), stoma formation (p = 0.006) and insertion of more than one intraabdominal drain during surgery (p = 0.005). Postoperative continuation of intravenous fluids (p = 0.027), reinsertion of urinary catheter (p = 0.045) and postoperative ileus (p = 0.020) were also strongly associated with delayed discharge on univariate analysis. After multivariate analysis the preoperative parameters CR-POSSUM score (p = 0.022), increasing BMI (p = 0.014) and preoperative albumin level (p = 0.031) were all independently associated with failure of ERAS. CONCLUSIONS: A variety of perioperative factors contribute to failure of ERAS in routine practice. CR-POSSUM can help to identify patients at risk for possible failure of ERAS. This may help to optimize avoidable factors, or accommodate those patients likely to require a longer post-operative stay.

[Learning from aviation - how to increase patient safety in surgery]. / Kann die Chirurgie wirklich von der Luftfahrt lernen?

During the last years attempts have been made to draw lessons from aviation to increase patient safety in medicine. In particular similar conditions are present in surgery as pilots and surgeons may have to support high physical and mental pressure. The use of a few safety instruments from aviation is feasible in an attempt to increase safety in surgery. First a "root caused" accident research may be established. This is achievable by morbidity and mortality conferences and critical incident reporting systems (CIRS). Second, standard operating procedures may assure a uniform mental model of team members. Furthermore, crew resource management illustrates a strategy and attitude concept, which is applicable in all situations. Safety instruments from aviation, therefore, seem to have a high potential to increase safety in surgery when properly employed.

[The optimult study concept - selective neoadjuvant chemoradiation therapy based on preoperative MRI]. / Das Optimult-Studienkonzept - Grundlage für selektiven Einsatz neoadjuvanter Radiochemotherapie auf MRT-Basis?

Optimal surgery for rectal cancer, i. e., total mesorectal excision in the middle and lower rectum reduces local recurrence substantially. Multi-modal therapy further improves the rate of local recurrence in advanced rectal cancer. In Germany neoadjuvant chemoradiation therapy is most frequently given for these tumours. However, clinical staging by endosonography, CT scan and / or MRI is unreliable, particulary as regards lymph node category, which entails overtreatment of a relevant number of patients secondary to overstaging. Thus, a subgroup of patients has to tolerate side effects and long-term sequelae of neoadjuvant therapy without having oncological benefit from this pretreatment. It is of note that the prognosis of patients with advanced rectal cancer depends not only on the T and N category but also on the free circumferential margin of the tumour as determined by pathological examination. In contrast to the T and N category, the latter may be predicted before treatment by pelvic MRI. While several case series demonstrated that low local recurrence rates are achieved in patients when preoperative MRI showed free circumferential margins, this concept was never tested in a randomised controlled trial. We, therefore, designed a two-armed randomised study with patients who suffer from rectal cancer and who have 2 mm or more free circumferential margins on their preoperative MRI. These patients are either operated without pretreatment (intervention arm) or receive neoadjuvant chemoradiation therapy with subsequent surgery (control arm). If local recurrence in the intervention arm is not inferior to the control arm, this study may form the basis for an individualised therapeutic concept for rectal cancer based on preoperative MRI. Potentially, chemoradiation therapy may be avoided in the future for patients who will have no oncological benefit from this treatment modality.

Influence of interapplicator distance on multibipolar radiofrequency ablation during physiological and interrupted liver perfusion in an in vivo porcine model.

Radiofrequency ablation (RFA) is a curative treatment option for early stage hepatocellular carcinoma (HCC). Vascular inflow occlusion to the liver (Pringle manoeuvre) and multibipolar RFA (mbRFA) represent possibilities to generate large ablations. This study evaluated the impact of different interapplicator distances and a Pringle manoeuvre on ablation area and geometry of mbRFA. 24 mbRFA were planned in porcine livers in vivo. Test series with continuous blood flow had an interapplicator distance of 20 mm and 15 mm, respectively. For a Pringle manoeuvre, interapplicator distance was predefined at 20 mm. After liver dissection, ablation area and geometry were analysed macroscopically and histologically. Confluent and homogenous ablations could be achieved with a Pringle manoeuvre and an interapplicator distance of 15 mm with sustained hepatic blood flow. Ablation geometry was inhomogeneous with an applicator distance of 20 mm with physiological liver perfusion. A Pringle manoeuvre led to a fourfold increase in ablation area in comparison to sustained hepatic blood flow (p < 0.001). Interapplicator distance affects ablation geometry of mbRFA. Strict adherence to the planned applicator distance is advisable under continuous blood flow. The application of a Pringle manoeuvre should be considered when compliance with the interapplicator distance cannot be guaranteed.

COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.

INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. TRIAL DESIGN: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. TRIAL REGISTRATION: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).

[Transanal total mesorectal excision-a critical appraisal]. / Transanale totale mesorektale Exzision ­ eine kritische Standortbestimmung.

INTRODUCTION: Total mesorectal excision (TME) is the international standard for rectal cancer surgery. In addition to laparoscopic TME (lapTME), transanal TME (taTME) was developed in recent years to reduce the rate of incomplete TME, conversion to open surgery and postoperative functional impairment. Despite limited evidence, this technique is becoming increasingly more popular and is already routinely used by many hospitals for rectal cancer in varying tumor level locations. The aim of this review was to evaluate the taTME compared to anterior rectal resection with lapTME as the standard of care in rectal cancer surgery based on currently available evidence. METHOD: The databases PubMed and Medline were systematically searched for publications on transanal total mesorectal excision (taTME) and transanal minimally invasive surgery (TAMIS). Relevant studies were selected and further research based on the reference lists was undertaken. RESULTS: A total of 16 studies analyzing 3782 patients were identified. The taTME does not lead to a higher rate of complete TME-resected specimens compared to the standard procedure. So far, superiority could not be demonstrated for complication rates or for functional or oncological results. Serious complications secondary to dissection in incorrect planes were observed. The anastomotic level generally seems to be closer to the sphincter after taTME versus anterior lapTME. CONCLUSION: Considering current evidence, taTME failed to show superiority compared to conventional anterior lapTME. Although taTME has some potential advantages, it carries substantial risks. If performed outside of clinical trials, it should therefore only be used in carefully selected patients with a high possibility of conversion, following adequate patient informed consent and after intense and systematic training of the surgeon.