AIM:To prospectively evaluate the effect of preoperative radiotherapy followed by surgery versus surgery alone on patient-reported outcomes (PROs) 1 year after surgery. METHOD:Prospective observational cohort study in 127 colorectal cancer centres. Patients with rectal cancer completed European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC-QLQ-C30) and Colorectal module (-CR29) questionnaires (thus providing PROs) before initialization of treatment [baseline (T0)] and at 12 months after surgery [follow up (T1)]. The PRO data together with sociodemographic information were linked to clinical data. Relevant confounders were identified using directed acyclic graphs. The effect of preoperative radiotherapy on selected PROs 12 months after surgery was estimated using adjusted tobit regression models. RESULTS:Of 1635 patients with rectal cancer for whom both baseline and follow-up PROs were available, 565 (35%) received preoperative radiotherapy. Twelve months after surgery, patients with surgery alone reported better scores for global health status/Quality of Life, urinary incontinence, faecal incontinence (patients without stoma), dyspareunia (female patients) and impotence (male patients) than did patients receiving preoperative radiotherapy. The statistically significant effects ranged between 33.20 (p < 0.001, R2 = 0.19) for impotence and 39.01 (p = 0.001, R2 = 0.10) for dyspareunia. For global health status/QoL and urinary incontinence, no statistically significant effect could be found. CONCLUSION:Radiotherapy in addition to surgery negatively affects selected PROs 1 year after surgery in patients with rectal cancer. Compared with surgery alone, patients report profoundly impaired bowel and sexual function after preoperative radiotherapy. However, global health status/QoL was not affected statistically significantly. These results are an important argument for limiting preoperative radiotherapy to patients with a high risk of recurrence of rectal cancer and may facilitate informed decision-making. TRIAL REGISTRATION:German Clinical Trial Registry Number DRKS00008724 (https://drks.de/search/de/trial/DRKS00008724).

Objective:The DELORES trial investigated whether laparoscopic resection rectopexy (LRR) is superior to Delorme's procedure (DP) in full-thickness rectal prolapse.Background:Multiple perineal and transabdominal procedures are current practice for rectal prolapse surgery. Evidence from adequately designed randomized studies addressing the question of which of these procedures are superior in terms of recurrence and bowel function is lacking.Methods:DELORES was a randomized, observer-blinded, expertise-based multicenter trial. Patients with full-thickness rectal prolapse were eligible. The primary outcome was time to recurrence of full-thickness rectal prolapse within 24 months after primary surgery. The main secondary endpoints were morbidity, hospital stay, quality of life, constipation, and fecal incontinence (DRKS00000482).Results:A total of 358 patients were screened between September 2010 and January 2016. Based on screening, 70 patients were randomized and 65 were included in the analysis (33 LRR and 32 DP procedures). The median follow-up was 23.9 months. Analysis of the primary outcome showed that LRR was superior to DP (P=0.0012). During the 24-month follow-up, 8.2% of patients in the LRR group had a full-thickness prolapse recurrence versus 42.8% in the DP group. The median time to recurrence was 17.8 months for LRR and 8.2 months for DP. The median duration of surgery was 212 min (LRR) versus 77 min (DP). Overall postoperative morbidity was low. The reoperation rate was higher for DP (0% LRR vs. 33.3% DP). Quality of life (FIQL) and incontinence scores (Wexner) were more favorable for LRR at 24-month follow-up.Conclusions:LRR is superior to DP in terms of recurrence and has favorable functional results.

OBJECTIVE:The DELORES trial investigated whether laparoscopic resection rectopexy (LRR) is superior to Delorme's procedure (DP) in full-thickness rectal prolapse. BACKGROUND:Multiple perineal and transabdominal procedures are current practice for rectal prolapse surgery. Evidence from adequately designed randomized studies addressing the question of which of these procedures are superior in terms of recurrence and bowel function is lacking. METHODS:DELORES was a randomized, observer-blinded, expertise-based multicenter trial. Patients with full-thickness rectal prolapse were eligible. The primary outcome was time to recurrence of full-thickness rectal prolapse within 24 months after primary surgery. The main secondary endpoints were morbidity, hospital stay, quality of life, constipation, and fecal incontinence (DRKS00000482). RESULTS:A total of 358 patients were screened between September 2010 and January 2016. Based on screening, 70 patients were randomized and 65 were included in the analysis (33 LRR and 32 DP procedures). The median follow-up was 23.9 months. Analysis of the primary outcome showed that LRR was superior to DP ( P =0.0012). During the 24-month follow-up, 8.2% of patients in the LRR group had a full-thickness prolapse recurrence versus 42.8% in the DP group. The median time to recurrence was 17.8 months for LRR and 8.2 months for DP. The median duration of surgery was 212 min (LRR) versus 77 min (DP). Overall postoperative morbidity was low. The reoperation rate was higher for DP (0% LRR vs. 33.3% DP). Quality of life (FIQL) and incontinence scores (Wexner) were more favorable for LRR at 24-month follow-up. CONCLUSIONS:LRR is superior to DP in terms of recurrence and has favorable functional results.

BACKGROUND:Postoperative paralytic ileus (POI) is a significant concern following gastrointestinal tumor surgery. Effective preventive and therapeutic strategies are crucial but remain elusive. Current evidence from randomized-controlled trials on pharmacological interventions for prevention or treatment of POI are systematically reviewed to guide clinical practice and future research. MATERIALS AND METHODS:Literature was systematically searched for prospective randomized-controlled trials testing pharmacological interventions for prevention or treatment of POI after gastrointestinal tumor surgery. Meta-analysis was performed using a random effects model to determine risk ratios and mean differences with 95% CI. Risk of bias and evidence quality were assessed. RESULTS:Results from 55 studies, involving 5078 patients who received experimental interventions, indicate that approaches of opioid-sparing analgesia, peripheral opioid antagonism, reduction of sympathetic hyperreactivity, and early use of laxatives effectively prevent POI. Perioperative oral Alvimopan or intravenous administration of Lidocaine or Dexmedetomidine, while safe regarding cardio-pulmonary complications, demonstrated effectiveness concerning various aspects of postoperative bowel recovery [Lidocaine: -5.97 (-7.20 to -4.74)h, P <0.0001; Dexmedetomidine: -13.00 (-24.87 to -1.14)h, P =0.03 for time to first defecation; Alvimopan: -15.33 (-21.22 to -9.44)h, P <0.0001 for time to GI-2 ] and length of hospitalization [Lidocaine: -0.67 (-1.24 to -0.09)d, P =0.02; Dexmedetomidine: -1.28 (-1.96 to -0.60)d, P =0.0002; Alvimopan: -0.58 (-0.84 to -0.32)d, P <0.0001] across wide ranges of evidence quality. Perioperative nonopioid analgesic use showed efficacy concerning bowel recovery as well as length of hospitalization [-1.29 (-1.95 to -0.62)d, P =0.0001]. Laxatives showed efficacy regarding bowel movements, but not food tolerance and hospitalization. Evidence supporting pharmacological treatment for clinically evident POI is limited. Results from one single study suggest that Neostigmine reduces time to flatus and accelerates bowel movements [-37.06 (-40.26 to -33.87)h, P <0.0001 and -42.97 (-47.60 to -38.35)h, P <0.0001, respectively] with low evidence quality. CONCLUSION:Current evidence concerning pharmacological prevention and treatment of POI following gastrointestinal tumor surgery is limited. Opioid-sparing concepts, reduction of sympathetic hyperreactivity, and laxatives should be implemented into multimodal perioperative approaches.

BACKGROUND:Colorectal and pancreatic carcinoma are the most common cancers of the gastrointestinal tract. Their surgical treatment carries a high morbidity: complications arise in 25% to 30% of cases, often prolonging recovery times and delaying the initiation of adjuvant therapy, leading, in turn, to worse oncological outcomes. The goal of multimodal perioperative management (mPOM) is to lower the postoperative complication rate through a combination of perioperative measures. METHODS:This guideline on the perioperative management of gastrointestinal tumors (POMGAT) meets all requirements for an S3 guideline as specified by the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF). These include a systematic literature search, quality assessment of the included publications, an evaluation of the reliability of the evidence according to the GRADE approach, and a structured consensus process. RESULTS:Meta-analyses have shown that mPOM lowers the complication rates of both pancreatic and colorectal resections (RD 0.96 with 95% confidence interval [0.92; 0.99] and RR 0.66 [0.54; 0.80], respectively). This shortens the hospital stay after pancreatic resections by a median of 2.33 days [-2.98; -1.69] and after colorectal resections by a median of 2.59 days [-3.22; -1.97]. CONCLUSION:Adherence to the POMGAT-S3 guideline for pancreatic and colorectal cancer surgery is associated with improved recovery, which can lead to a faster return to intended oncological treatment (RIOT) and thus to better long-term outcomes. These recommendations are not restricted to gastrointestinal cancer surgery; they can also be applied to visceral surgery for benign conditions, as well as to gynecological and urological operations.

Supplementary Figures S1-S2 from Analysis of Specific Transcriptional Regulators as Early Predictors of Independent Prognostic Relevance in Resected Colorectal Cancer

Supplementary Figures S1-S2; Supplementary Table S1.

BACKGROUND In this observational study, patient-reported outcomes and short-term clinical outcome parameters in patients with colorectal cancer were studied 12 months after the start of treatment. Outcomes were also compared across German Certified Colorectal Cancer Centres. METHODS Data were collected from 4239 patients with colorectal cancer who had undergone elective tumor resection in one of 102 colorectal cancer centers and had responded to a quality-of-life questionnaire before treatment (EORTC QLQ-C30 and -CR29). 3142 (74.1%) of these patients completed a post-treatment questionnaire 12 months later. Correlation analyses were calculated and case-mix adjusted comparisons across centers were made for selected patient-reported outcomes, anastomotic insufficiency, and 30-day-mortality. RESULTS At 12 months, mild improvements were seen in mean quality-of-life scores (66 vs. 62 points), constipation (16 vs. 19), and abdominal pain (15 vs. 17). Worsening was seen in physical function (75 vs. 82) and pain (22 vs. 19). Better patient-reported outcomes at 12 months were associated with better scores before treatment. Better results in at least three of the five scores were associated with male sex, higher educational level, higher age, and private health insurance. Major worsening of fecal incontinence was seen among patients with rectal cancer without a stoma. The largest differences across centers were found with respect to physical function. Anastomotic insufficiency was found in 4.3% of colon cancer patients and 8.2% of rectal cancer patients. 1.9% of patients died within 30 days after their resection. CONCLUSION Clinicians can use these findings to identify patients at higher risk for poorer patient-reported outcomes. The differences among cancer centers that were found imply that measures for quality improvement would be desirable.

ZusammenfassungMalignome zählen insbesondere im höheren Alter zu den häufigsten Erkrankungen und sind in Deutschland für 25% aller Todesfälle verantwortlich. Insbesondere bei Karzinomen des Gastrointestinaltraktes ist eine Heilung oft nur durch eine ausgedehnte Operation mit signifikanter Morbidität erreichbar. Vor etwa 25 Jahren wurde erstmalig das multimodale, perioperative Fast-Track-Konzept (FT-Konzept) zur Reduktion von postoperativen Komplikationen vorgestellt und in den folgenden Jahren um weitere Bausteine erweitert. Mittlerweile gibt es Hinweise, dass bei einer Umsetzung bzw. Adhärenz der Schlüsselbausteine von über 70% neben einer Reduktion der Komplikationsrate und einer verkürzten Krankenhausverweildauer ein verbessertes onkologisches Outcome möglich sein könnte. Trotz des hohen Bekanntheitsgrades und der nachgewiesenen Vorteile des FT-Konzeptes ist die Implementierung und Aufrechterhaltung der Maßnahmen schwierig und resultiert in einer Adhärenz von nur 20 – 40%. Dies hat viele Gründe: Neben einer fehlenden interdisziplinären und interprofessionellen Kooperation sowie dem hohen zeitlichen und logistischen Aufwand bei der Implementierung und Aufrechterhaltung werden häufig limitierte personelle Ressourcen als ursächlich aufgeführt. Wir haben diese Aspekte zum Anlass genommen und mit der Ausarbeitung einer S3-Leitlinie für die perioperative Behandlung zur beschleunigten Genesung von Patienten mit gastrointestinalen Tumoren begonnen. Durch die Erstellung einer im formalen Prozess konsentierten und evidenzbasierten, multidisziplinären Leitlinie wird eine Möglichkeit eröffnet, die aufgeführten Probleme durch eine Optimierung und Standardisierung der interdisziplinären Versorgung zu lösen, was insbesondere in einem Setting mit vielen verschiedenen Fachdisziplinen und deren unterschiedlichen Interessen wichtig ist. Weiterhin wird angestrebt, durch die Standardisierung der perioperativen Prozesse den zeitlichen und logistischen Aufwand zu reduzieren. Die Darstellung der Evidenz ermöglicht es, den personellen Mehraufwand gegenüber Krankenhausträgern und Krankenkassen transparenter zu gestalten und so auch besser zu begründen. Zusätzlich erlauben es die im Rahmen der Leitlinie generierten evidenzbasierten Qualitätsindikatoren, perioperative Standards in die Zertifizierungssysteme einzubeziehen und so die Qualität der perioperativen Medizin zu messen und zu überprüfen.

Colorectal cancer is associated with considerable impairment of quality of life as well as disease-specific symptoms and functional limitations. These can be assessed using standardized patient-reported outcome (PRO) instruments such as the EORTC QLQ-C30 and CR29 questionnaires. To date, no systematic investigation exists regarding which of the total 35 symptoms and functional limitations captured by the EORTC questionnaires are relevant to clinicians. This study aimed to identify the dimensions of the EORTC questionnaires most relevant to clinicians in the pretherapeutic assessment of colorectal cancer patients. An online survey was conducted (February–March 2021) in which clinicians from certified colorectal cancer centers were asked to rate the five most relevant scales (for colon and rectal cancer, respectively). The contacted cancer centers all participated in the EDIUM study, in which the PRO instruments were already used. The survey results were analyzed descriptively. Of 203 respondents, 96 took part in the survey (83 surgeons, 9 internists, 4 not specified/others). For colon, the scales “quality of life” (n = 80), “pain” (40), “physical function” (36), “constipation” (33), and “abdominal pain” (31) were most frequently reported; for rectum, these were the scales “quality of life” (74), “fecal incontinence” (62), “pain” (27), “physical function” (25), and “constipation” (25). The results show that in the pretherapeutic assessment of colorectal patients, the clinicians’ interest mainly focuses on the self-reported quality of life. However, in addition, colorectal cancer-specific symptoms are perceived as important, such as fecal incontinence (for rectum). The results can be used to select specific scales of PROs that are relevant in practice and for further development of these instruments.

ZusammenfassungDie Analfissur ist eine der häufigsten Pathologien, welche sich dem Proktologen präsentiert. Entsprechend ist es wichtig, verlässliche Leitlinien dazu zu entwickeln. Die aktuelle Leitlinie wurde anhand eines systematischen Literaturreview von einem interdisziplinären Expertengremium diskutiert und verabschiedet.Die akute Analfissur, soll auf Grund ihrer hohen Selbstheilungstendenz konservativ behandelt werden. Die Heilung wird am besten durch die Einnahme von Ballaststoff reicher Ernährung und einer medikamentösen Relaxation durch Kalziumkanal-Antagonisten (CCA) unterstützt. Zur Behandlung der chronischen Analfissur (CAF), soll den Patienten eine medikamentöse Behandlung zur „chemischen Sphinkterotomie“ mittels topischer CCA oder Nitraten angeboten werden. Bei Versagen dieser Therapie, kann zur Relaxation des inneren Analsphinkters Botulinumtoxin injiziert werden. Es ist belegt, dass die operativen Therapien effektiver sind. Deshalb kann eine Operation schon als primäre Therapie oder nach erfolgloser medikamentöser Therapie erfolgen. Die Fissurektomie, evtl. mit zusätzlicher Botulinumtoxin Injektion oder Lappendeckung, ist die Operation der Wahl. Obwohl die laterale Internus Sphinkterotomie die CAF effektiver heilt, bleibt diese wegen dem höheren Risiko für eine postoperative Stuhlinkontinenz eine Option für Einzelfälle.

(1) Background: Oncological gastrectomy requires complex multidisciplinary management. Clinical pathways (CPs) can potentially facilitate this task, but evidence related to their use in managing oncological gastrectomy is limited. This study evaluated the effect of a CP for oncological gastrectomy on process and outcome quality. (2) Methods: Consecutive patients undergoing oncological gastrectomy before (n = 64) or after (n = 62) the introduction of a CP were evaluated. Assessed parameters included catheter and drain management, postoperative mobilization, resumption of diet and length of stay. Morbidity, mortality, reoperation and readmission rates were used as indicators of outcome quality. (3) Results: Enteral nutrition was initiated significantly earlier after CP implementation (5.0 vs. 7.0 days, p < 0.0001). Readmission was more frequent before CP implementation (7.8% vs. 0.0%, p = 0.05). Incentive spirometer usage increased following CP implementation (100% vs. 90.6%, p = 0.11). Mortality, morbidity and reoperation rates remained unchanged. (4) Conclusions: After implementation of an oncological gastrectomy CP, process quality improved, while indicators of outcome quality such as mortality and reoperation rates remained unchanged. CPs are a promising tool to standardize perioperative care for oncological gastrectomy.

Anal fissure is one of the most common pathologies presenting to the coloproctologist. Reliable guidelines giving recommendations on diagnosis and treatment are needed. The present guidelines have been developed by a multinational and multidisciplinary panel of experts. The board discussed up-to-date scientific knowledge around anal fissure, on the basis of a thorough and systematic review of the available literature. Acute anal fissures often heal spontaneously. They should therefore be treated conservatively in the first instance, by intake of high-fiber diet and/or use of topical agents with a relaxing effect on the internal anal sphincter (e.& x202f;g. calcium channel antagonists (CCA)). Patients suffering from chronic anal fissure (CAF) should be offered a trial of "chemical sphincterotomy" by topical application of CCA/nitrates or alternatively injections of botulinum toxin. However, the most efficient treatment option for CAF is the surgical approach. Operative interventions can be offered as primary therapy or in recurrent/persisting anal fissures after failed medical therapy. Fissurectomy +/- Botulinum toxin injection or an anal advancement flap are recommended as first line operations in view of a low risk for faecal incontinence, although the lateral internal sphincterotomy shows quicker symptom relief and excellent fissure healing rates, at the price of a higher postoperative incontinence risk.

BackgroundRecurrent disease at the anastomotic site after bowel resection represents amajor problem in patients with Crohn's disease. In 2011, anew anastomotic technique (Kono-S anastomosis) was published, which as afunctional end-to-end anastomosis creating awide anastomotic diameter aimed to reduce the rate of recurrence after surgery.AimTo evaluate the Kono-S anastomosis with respect to early and late postoperative complications and recurrence rate after surgical intestinal resection in patients with Crohn's disease at auniversity center.Patients and methodsAll patients with Crohn's disease who underwent Kono-S anastomoses between June 2015 and December 2016at the Department of Surgery, University Medical Centre Mannheim, were included in the study. After obtaining informed consent, patient data regarding surgery and hospital stay were recorded in aprospective database. Follow-up was carried out by structured telephone interviews including disease progression, medication and surveillance. Statistical analysis was performed using the Graph Pad Prism7 software. Ethics board approval was obtained from the Medical Ethics CommissionII of the Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany (No.2017-575N-MA).ResultsA total of 53patients (32female and 21male) were included in this study. The median procedural time was 157min. The median follow-up was 12months (range 4-23months). Of the patients 3 developed early postoperative complications with aClavien-Dindo scoreIII and 25patients with or without symptoms were controlled by endoscopy and/or magnetic resonance imaging (MRI) and no anastomotic recurrence was detected. No endoscopic interventions were necessary and 16patients were symptom-free with no further specific therapy or controls.DiscussionThe Kono-S anastomosis is asafe anastomotic method with low morbidity. In the early follow-up recurrence rates of Crohn's disease at the anastomotic site were low. In the literature a reoperation rate of 5% per year is given for patients with Crohn's disease after intestinal resection, so that in the long-term observation a valid statement on recurrence rate is possible. Apotential advantage of the morphological end-to-end configuration of the Kono-S anastomosis is the better endoscopic dilatation compared to aside-to-side anastomosis.ConclusionThe Kono-S anastomotic technique has a low morbidity. In the early follow-up observational period no recurrence occurred in the anastomosis area in this series. Long-term data must clarify whether this technique is advantageous with respect to this aspect in the long run.

BACKGROUND:Pancreatic surgery demands complex multidisciplinary management. Clinical pathways (CPs) are a tool to facilitate this task, but evidence for their utility in pancreatic surgery is scarce. This study evaluated the effect of CPs on quality of care for pancreatoduodenectomy. METHODS:Data of all consecutive patients who underwent pancreatoduodenectomy before (n = 147) or after (n = 148) CP introduction were evaluated regarding catheter and drain management, postoperative mobilization, pancreatic enzyme substitution, resumption of diet and length of stay. Outcome quality was assessed using glycaemia management, morbidity, mortality, reoperation and readmission rates. RESULTS:Catheters and abdominal drainages were removed significantly earlier in patients treated with CP (p < 0.0001). First intake of liquids, nutritional supplement and solids was significantly earlier in the CP group (p < 0.0001). Exocrine insufficiency was significantly less common after CP implementation (47.3% vs. 69.7%, p < 0.0001). The number of patients receiving intraoperative transfusion dropped significantly after CP implementation (p = 0.0005) and transfusion rate was more frequent in the pre-CP group (p = 0.05). The median number of days with maximum pain level >3 was significantly higher in the CP group (p < 0.0001). There was no significant difference in mortality, morbidity, reoperation and readmission rates. CONCLUSIONS:Following implementation of a CP for pancreatoduodenectomy, several indicators of process and outcome quality improved, while others such as mortality and reoperation rates remained unchanged. CPs are a promising tool to improve quality of care in pancreatic surgery.

PURPOSE:Pancreatic surgery demands complex multidisciplinary management, which is often cumbersome to implement. Clinical pathways (CPs) are a tool to facilitate this task, but evidence for their utility in pancreatic surgery is scarce. This study evaluated if CPs are a suitable tool for process standardization in order to improve process and outcome quality in patients undergoing distal and total pancreatectomy. PATIENTS AND METHODS:Data of consecutive patients who underwent distal or total pancreatectomy before (n=67) or after (n=61) CP introduction were evaluated regarding catheter management, postoperative mobilization, pancreatic enzyme substitution, resumption of diet and length of stay. Outcome quality was assessed using glycaemia management, morbidity, mortality, reoperation and readmission rates. RESULTS:The usage of incentive spirometers for pneumonia prophylaxis increased. The median number of days with hyperglycemia decreased significantly from 2.5 to 0. For distal pancreatectomy, the incidence of postoperative diabetes dropped from 27.9% to 7.1% (p=0.012). The incidence of postoperative exocrine pancreatic insufficiency decreased from 37.2% to 11.9% (p=0.007). There was no significant difference in mortality, morbidity, reoperation and readmission rates between groups. CONCLUSION:Following implementation of a pancreatic surgery CP, several indicators of process and outcome quality improved, while others such as mortality and reoperation rates remained unchanged. CPs are a promising tool to improve quality of care in pancreatic surgery.