Oncological right hemicolectomy in a trimodal comparison: open surgery versus laparoscopic procedures with extra- and intracorporeal anastomosis technique.

PURPOSE: This study aimed to investigate the surgical short- and mid-term outcomes, as well as the impact on quality of life and recovery, following oncological right hemicolectomy. To accomplish this, three patient cohorts were examined, which included laparotomy OA), laparoscopy with intracorporeal anastomosis (LIA), and laparoscopy with extracorporeal anastomosis (LEA). Our hypothesis was that the group undergoing intracorporeal anastomosis would demonstrate superior outcomes compared to the other cohorts. METHODS: The analysis included a total of 135 patients who were enrolled between 2015 and 2020. In addition to retrospectively collected data, we conducted follow-up surveys using a validated Gastrointestinal Quality of Life Index (GIQLI) questionnaire and semi-structured interviews. These surveys were conducted between July and September 2021 to gather comprehensive information regarding the patients' quality of life. RESULTS: The study cohort was divided into OA (n = 67), LEA (n = 14), and LIA (n = 54). The duration of surgery was significantly longer in the laparoscopic groups (median = 200.5 (LEA) and 184.0 (LIA) min vs 170.0 min (OA); p = 0.007), while the length of hospital stay was significantly shorter (median = 6.0 and 7.0 days vs 9.0 days; p = 0.005). The overall postoperative complication rate was significantly higher in the laparotomy group compared to the intracorporeal group (64.2% vs 35.2%; p = 0.006), with the extracorporeal group having a rate of 42.9%. Reoperation within 30 days occurred exclusively in the open surgery group (n = 9; 13.43%; p = 0.007). The overall response rate to the survey was 75%. Overall, the GIQLI score was comparable among the three groups, and there were no significant differences in the questions related to recovery, regained function, and contentment. CONCLUSION: The laparoscopic approaches demonstrated significantly lower complication rates compared to laparotomy, while no significant differences were observed between the two laparoscopic techniques.

Remote ischemic preconditioning versus sham-control for prevention of anastomotic leakage after resection for rectal cancer (RIPAL trial): a pilot randomized controlled, triple-blinded monocenter trial.

PURPOSE: Remote ischemic preconditioning (RIPC) reportedly reduces ischemia‒reperfusion injury (IRI) in various organ systems. In addition to tension and technical factors, ischemia is a common cause of anastomotic leakage (AL) after rectal resection. The aim of this pilot study was to investigate the potentially protective effect of RIPC on anastomotic healing and to determine the effect size to facilitate the development of a subsequent confirmatory trial. MATERIALS AND METHODS: Fifty-four patients with rectal cancer (RC) who underwent anterior resection were enrolled in this prospectively registered (DRKS0001894) pilot randomized controlled triple-blinded monocenter trial at the Department of Surgery, University Medicine Mannheim, Mannheim, Germany, between 10/12/2019 and 19/06/2022. The primary endpoint was AL within 30 days after surgery. The secondary endpoints were perioperative morbidity and mortality, reintervention, hospital stay, readmission and biomarkers of ischemia‒reperfusion injury (vascular endothelial growth factor, VEGF) and cell death (high mobility group box 1 protein, HMGB1). RIPC was induced through three 10-min cycles of alternating ischemia and reperfusion to the upper extremity. RESULTS: Of the 207 patients assessed, 153 were excluded, leaving 54 patients to be randomized to the RIPC or the sham-RIPC arm (27 each per arm). The mean age was 61 years, and the majority of patients were male (37:17 (68.5:31.5%)). Most of the patients underwent surgery after neoadjuvant therapy (29/54 (53.7%)) for adenocarcinoma (52/54 (96.3%)). The primary endpoint, AL, occurred almost equally frequently in both arms (RIPC arm: 4/25 (16%), sham arm: 4/26 (15.4%), p = 1.000). The secondary outcomes were comparable except for a greater rate of reintervention in the sham arm (9 (6-12) vs. 3 (1-5), p = 0.034). The median duration of endoscopic vacuum therapy was shorter in the RIPC arm (10.5 (10-11) vs. 38 (24-39) days, p = 0.083), although the difference was not statistically significant. CONCLUSION: A clinically relevant protective effect of RIPC on anastomotic healing after rectal resection cannot be assumed on the basis of these data.

Influence of motivational interviewing on postoperative mobilization in the enhanced recovery after surgery (ERAS®) pathway in elective colorectal surgery - a randomized patient-blinded pilot study.

PURPOSE: Early mobilization is an essential component of the Enhanced Recovery after Surgery (ERAS®)-pathway. However, a large percentage of patients fail to achieve the ERAS® recommended goal (360 min out of bed from post-operative day 1/POD1). Motivational Interviewing (MI) is an evidence-based type of patient-centered consultation to promote intrinsic motivation. This study aims to evaluate if MI can improve postoperative mobilization. METHODS: This two-arm, patient-blinded pilot randomized controlled trial included ERAS®-patients undergoing elective bowel resections. Conversations were validated by MI Treatment Integrity. Two validated motion sensors (movisens) and self-assessments were used to measure mobilization (POD1-POD3: Time out of bed, time on feet and step count). RESULTS: 97 patients were screened, 60 finally included and randomized. Cumulatively across POD1-3, the intervention group (IG) was longer out of bed than the control group (CG) (median: 685 vs. 420 min; p=0.022). The IG achieved the ERAS®-goal of 360 min/day more frequently across POD1-3 (27.4% vs. 10.61%; p=0.013). Time on feet was 131.5 min/day (median per POD) in IG vs. 95.8 min/day in the CG (p=0.212), step count was 1347 in IG vs. 754 steps/day in CG (p=0.298). CONCLUSION: MI could be conducted low threshold and was well accepted by patients. MI can improve mobilization in the context of ERAS®. Despite better performance, it should be noted that only 27.4% of the IG reached the ERAS®-compliance goal of 360 min/day. The findings of this pilot study stipulate to further test the promising perioperative effects of MI within a multicenter superiority trial. REGISTRATION: This study was registered prospectively in the German Clinical Trials Register on 25.02.2022. Trial registration number is "DRKS00027863".

Personalized checkpoint acupuncture can reduce postoperative pain after abdominal surgery-a STRICTA-conform pilot study.

BACKGROUND: Optimal pain management is one of the core elements of Enhanced Recovery After Surgery (ERAS®) protocols and remains a challenge. Acupuncture (AC) is an effective treatment for various pain conditions. Systematic and personalized allocation of acupoints may be decisive for efficacy. METHODS: Based on the predominant pressure sensitivity of six gastrointestinal (GI) checkpoints (G1-G6), we devised a method to detect personalized patterns of pain and a corresponding set of acupoints. We performed a single AC treatment with semi-permanent needles and assessed the visual analogue scale (VAS) score, pain threshold based on pressure algometry (PA), and temperature changes on abdominal skin areas before and 5 min after AC. RESULTS: Between April and June 2021, thirty-eight patients were prospectively included in this pilot study. The mean reduction in subjective pain sensation as assessed by VAS was 86%, paralleled by an augmentation of the pain threshold as measured by PA by 64%. A small but significant increase in the skin temperature was observed above the abdominal surface. These effects were independent of the type of surgery. CONCLUSION: Checkpoint acupuncture may be a complementary tool for postoperative pain management. Further investigations are needed to explore this analgesic effect.

Management of colorectal anastomotic leakage using endoscopic negative pressure therapy with or without protective ostomy: a retrospective study.

PURPOSE: Management of colorectal anastomotic leakage (AL) is patient-oriented and requires an interdisciplinary approach. We analyzed the management of AL according to its severity and presence of ostomy and proposed a therapy algorithm. METHODS: We identified all patients who underwent colorectal surgery and developed an AL in our clinic between 2012 and 2017. The management of AL was retrospectively analyzed according to the severity grade: asymptomatic (A), requesting interventional or antibiotic therapy (B), undergoing re-operation (C). The groups were compared according to the leakage characteristics, presence of ostomy, and patient clinical conditions. RESULTS: We identified 784 consecutive patients meeting the inclusion criteria. Of these, 10.8% experienced an AL (A = 18%, B = 48%, and C = 34%). The rate of successful ostomy closure was 100% (A), 68% (B), and 62% (C), respectively. Within group B, 91% of the patients were treated solely by endoscopic negative pressure therapy (ENPT), whereas 37% of the patients within group C required ENPT in addition to surgery. Seven cases within group B (17%) required no protective ostomy (nOB) during ENPT which was itself shorter and required less cycles in comparison to group B with ostomy (OB) (p = 0.017 and 0.111, respectively). Moreover, the leakage distance to anal verge was higher in the OB subgroup (p < 0.001). CONCLUSION: ENPT for the treatment of colorectal AL is efficient in combination with operative revision or protective ostomy. In selected patients, it is feasible also in the absence of a protective ostomy.

Colon ischemia in patients with severe COVID-19: a single-center retrospective cohort study of 20 patients.

PURPOSE: Thromboembolic complications due to COVID-19 are common in patients requiring critical care and are associated with high morbidity and mortality rates. The aim of this study was to evaluate clinical manifestations and postoperative outcomes after colectomy for COVID-19-associated colonic ischemia in the first versus the second wave of the pandemic. METHODS: A retrospective cohort study of patients with severe COVID-19 at our institution between 1 March 2020 and 31 January 2021 was performed. All patients with severe COVID-19, requiring critical care and surgical treatment of colonic ischemia, were included. The main outcomes were surgical complications and mortality rate. RESULTS: A total of 190 patients were included of whom 20 (10.5%) patients underwent surgery for colon ischemia. Preoperatively, D-dimer was elevated, especially in the first wave (median 15.24 (interquartile range 6.00-32.00) vs. 2.09 (1.42-4.28) mg/L, p = 0.025). Twelve (60%) patients underwent a (sub)total colectomy, 7 (35%) a right hemicolectomy, and one patient (5%) an ileocecal resection. Grade 3b complications occurred in one of 5 patients (20%) in the first and in 9 of 15 patients (60%) in the second wave. The overall in-hospital mortality was similar in both waves (40% vs. 47%), with death occurring after a median stay of 21 days. CONCLUSION: In this cohort study of patients with severe COVID-19 and colonic ischemia, clinical presentation and laboratory findings varied. However, the majority of patients required (sub)total colectomy. Despite a lower threshold to surgery in the second wave, mortality remained high.

Less is more-the best test for anastomotic leaks in rectal cancer patients prior to ileostomy reversal.

PURPOSE: No clear consensus exists on how to routinely assess the integrity of the colorectal anastomosis prior to ileostomy reversal. The objective of this study was to evaluate the accuracy of contrast enema, endoscopic procedures, and digital rectal examination in rectal cancer patients in this setting. METHODS: A systematic literature search was performed. Studies assessing at least one index test for which a 2 × 2 table was calculable were included. Hierarchical summary receiver operating characteristic curves were calculated and used for test comparison. Paired data were used where parameters could not be calculated. Methodological quality was assessed with the QUADAS-2 tool. RESULTS: Two prospective and 11 retrospective studies comprising 1903 patients were eligible for inclusion. Paired data analysis showed equal or better results for sensitivity and specificity of both endoscopic procedures and digital rectal examination compared to contrast enema. Subgroup analysis of contrast enema according to methodological quality revealed that studies with higher methodological quality reported poorer sensitivity for equal specificity and vice versa. No case was described where a contrast enema revealed an anastomotic leak that was overseen in digital rectal examination or endoscopic procedures. CONCLUSIONS: Endoscopy and digital rectal examination appear to be the best diagnostic tests to assess the integrity of the colorectal anastomosis prior to ileostomy reversal. Accuracy measures of contrast enema are overestimated by studies with lower methodological quality. Synopsis of existing evidence and risk-benefit considerations justifies omission of contrast enema in favor of endoscopic and clinical assessment. TRIAL REGISTRATION: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019107771.

Association of ileocolic pedicle division with postoperative complications after restorative proctocolectomy and ileal pouch-anal anastomosis for ulcerative colitis.

BACKGROUND: When performing a restorative proctocolectomy (RPC) with an ileal pouch-anal anastomosis (IPAA), it is common practice to divide the ileocolic artery (ICA) if the patient has a tumor or dysplasia, or in order to gain sufficient length to secure a tension-free anastomosis. However, it is unclear whether there is an association between division of the ICA and the rate of postoperative complications. METHODS: We retrospectively analysed all patients with ulcerative colitis who underwent RPC and IPAA in our department between January 2010 and December 2016. These were divided in two groups, with regard to the ICA being preserved (PRE group) or divided (DIV group). Complications such as stenosis or leakage of the IPAA, perianal fistulas, abscess formation within the lesser pelvis and pouchitis were analysed and compared between both groups. RESULTS: We identified 130 patients meeting the study inclusion criteria, 49 patients in the PRE and 81 patients in the DIV group. No statistical significance was observed in IPAA leakages (p = 0.71), anastomotic strictures (p = 0.33), fistulas (p = 0.19) and pouchitis (p = 0.72). Abscess formation frequency was similar in both groups (p > 0.99). Moreover, short-term (p = 0.53) and long-term complications (p = 0.11) were similar in both groups. A higher conversion rate was observed in obese (p = 0.006) and male (p = 0.02) patients. Within the entire study population, fistulas and IPAA leakages were associated with a higher rate of anastomotic strictures (p = 0.008 and p = 0.02 respectively). CONCLUSION: Our data suggest similar IPAA related complications after either division or preservation of the ICA. Further trials are required in order to examine the trends observed in this study.

Definition and severity grading of postoperative lymphatic leakage following inguinal lymph node dissection.

PURPOSE: Lymphatic complications occur frequently after radical inguinal lymph node dissection (RILND). The incidence of lymphatic leakage varies considerably among different studies due to the lack of a consistent definition. The aim of the present study is to propose a standardized definition and grading of different types of lymphatic leakage after groin dissection. METHODS: A bicentric retrospective analysis of 82 patients who had undergone RILND was conducted. A classification of postoperative lymphatic leakage was developed on the basis of the daily drainage output, any necessary postoperative interventions and reoperations, and any delay in adjuvant treatment. RESULTS: In the majority of cases, RILND was performed in patients with inguinal metastases of malignant melanoma (n = 71). Reinterventions were necessary in 15% of the patients and reoperations in 32%. A new classification of postoperative lymphatic leakage was developed. According to this definition, grade A lymphatic leakage (continued secretion of lymphatic fluid from the surgical drains without further complications) occurred in 13% of the patients, grade B lymphatic leakage (persistent drainage for more than 10 postoperative days or the occurrence of a seroma after the initial removal of the drain that requires an intervention) in 28%, and grade C lymphatic leakage (causing a reoperation or a subsequent conflict with medical measures) in 33%. The drainage volume on the second postoperative day was a suitable predictor for a complicated lymphatic leakage (grades B and C) with a cutoff of 110 ml. CONCLUSION: The proposed definition is clinically relevant, is easy to employ, and may serve as the definition of a standardized endpoint for the assessment of lymphatic morbidity after RILND in future studies.

Tissue sealants for the prevention of lymphoceles after radical inguinal lymph node dissection in patients with melanoma: A systematic review and individual patient data meta-analysis.

BACKGROUND AND OBJECTIVES: Postoperative lymphoceles and further wound complications occur frequently after radical inguinal lymph node dissection (ILND). In various studies, tissue sealants have shown to reduce the incidence of postoperative morbidity. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effectiveness of tissue sealants in reducing the incidence of postoperative lymphoceles following ILND in patients with melanoma was conducted. Individual patient data was requested to pool the data for meta-analysis appropriately. RESULTS: Thousand seven hundred twenty-nine manuscripts were screened for eligibility. Six RCTs published between 1986 and 2012 were identified including 194 patients for ILND. Only four RCTs were included in the meta-analysis. No study properly defined the term "lymphocele." Tissue sealants failed to influence the duration of drain placement (mean difference [MD] = -3.05 days; z = 1.18; P = 0.24), total drainage volume (MD = 598.39 mL; z = 1.49; P = 0.14), the incidence of postoperative seroma, wound infection and skin necrosis. CONCLUSIONS: No improvement was identified with the use of tissue sealants, however, a valid comparison of the results of included trials was difficult owing to the lack of a definition of the term "lymphocele." Other surgical techniques and trials using validated endpoint definitions are required to reevaluate these findings.

Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation.

BACKGROUND: A parastomal hernia is defined as an incisional hernia related to a stoma, and belongs to the most common stoma-related complications. Many factors, which are considered to influence the incidence of parastomal herniation, have been investigated. However, it remains unclear whether the enterostomy should be placed through, or lateral to the rectus abdominis muscle, in order to prevent parastomal herniation and other important stoma complications. OBJECTIVES: To assess if there is a difference regarding the incidence of parastomal herniation and other stoma complications, such as ileus and stenosis, in lateral pararectal versus transrectal stoma placement in people undergoing elective or emergency abdominal wall enterostomy. SEARCH METHODS: For this update, we searched for all types of published and unpublished randomized and non-randomized studies in four medical databases: CENTRAL, PubMed, LILACS, Science Ciation Index, and two trials registers: ICTRP Search Portal and ClinicalTrials.gov to 9 November 2018. We applied no language restrictions. SELECTION CRITERIA: Randomized and non-randomized studies comparing lateral pararectal versus transrectal stoma placement with regard to parastomal herniation and other stoma-related complications. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study quality and extracted data. We conducted data analyses according to the recommendations of Cochrane and the Cochrane Colorectal Cancer Group (CCCG). We rated quality of evidence according to the GRADE approach. MAIN RESULTS: Randomized controlled trials (RCT)Only one RCT met the inclusion criteria. The participants underwent enterostomy placement in the frame of an operation for: rectal cancer (37/60), ulcerative colitis (14/60), familial adenomatous polyposis (7/60), and other (2/60).The results between the lateral pararectal and the transrectal approach groups were inconclusive for the incidence of parastomal herniation (risk ratio (RR) 1.34, 95% confidence interval (CI) 0.40 to 4.48; low-quality evidence); development of ileus or stenosis (RR 2.0, 95% CI 0.19 to 20.9; low-quality evidence); or skin irritation (RR 0.67, 95% CI 0.21 to 2.13; moderate-quality evidence). The results were also inconclusive for the subgroup analysis in which we compared the effect of ileostomy versus colostomy on parastomal herniation. The study did not measured other stoma-related morbidities, or stoma-related mortality, but did measure quality of life, which was not one of our outcomes of interest.Non-randomized studies (NRS)Ten retrospective cohort studies, with a total of 864 participants, met the inclusion criteria. The indications for enterostomy placement and the baseline characteristics of the participants (age, co-morbidities, disease-severity) varied between studies. All included studies reported results for the primary outcome (parastomal herniation) and one study also reported data on one of the secondary outcomes (stomal prolapse).The effects of different surgical approaches on parastomal herniation (RR 1.22, 95% CI 0.84 to 1.75; 10 studies, 864 participants; very low-quality evidence) and the occurrence of stomal prolapse (RR 1.23, 95% CI 0.39 to 3.85; 1 study, 145 participants; very low-quality evidence) are uncertain.None of the included studies measured other stoma-related morbidity or stoma-related mortality. AUTHORS' CONCLUSIONS: The present systematic review of randomized and non-randomized studies found inconsistent results between the two compared interventions regarding their potential to prevent parastomal herniation.In conclusion, there is still a lack of high-quality evidence to support the ideal surgical technique of stoma formation. The available moderate-, low-, and very low-quality evidence, does not support or refute the superiority of one of the studied stoma formation techniques over the other.

Influence of complete administration of adjuvant chemotherapy cycles on overall and disease-free survival in locally advanced rectal cancer: post hoc analysis of a randomized, multicenter, non-inferiority, phase 3 trial.

BACKGROUND: A randomized trial demonstrated that capecitabine is at least as effective as fluorouracil in the adjuvant treatment of patients with locally advanced rectal cancer. However, not all patients receive all planned cycles of chemotherapy. Therefore it is of interest how complete or partial administration of chemotherapy influences oncological outcome. METHODS: A post hoc analysis of a trial with 401 randomized patients, nine being excluded because of missing data, was performed. 392 patients (197 - capecitabine, 195 - fluorouracil) could be analyzed regarding the number of administered adjuvant chemotherapy cycles. In the subgroup of 361 patients with an overall survival of at least six months, five-year overall and disease-free survival were analyzed in respect to completion (complete vs. incomplete) of chemotherapy cycles. Survival rates and curves were calculated and compared using the log-rank test. The effect of completion of chemotherapy was adjusted for relevant confounding factors. RESULTS: Two hundred fifty-one (64.0%) of analyzed patients received all postoperative scheduled cycles. Five-year overall survival was significantly better in these patients compared to the incomplete group (76.0 vs. 60.6%, p < 0.0001). Of 361 patients with an overall survival of at least six months, 251(69.5%) patients received all cycles. Five-year overall survival was also significantly better than in the incomplete group (76.0 vs. 66.4%, p = 0.0073). Five-year disease free survival was numerically better (64.9 vs. 58.7%, p = 0.0646; HR [not all cycles vs. all cycles] = 1.42 95% CI: [0.98, 2.07]). Cox regression models show a non-significant better OS (p = 0.061) and DFS (p = 0.083), if chemotherapy cycles were administered completely. CONCLUSION: Complete administration of chemotherapy cycles was associated with improved five-year overall and disease-free survival in patients with locally advanced rectal cancer.

Transabdominal laparoscopic retroperitoneal neurectomy for chronic pain after inguinal hernia repair and appendicectomy -a matched-pair study.

BACKGROUND: Chronic debilitating pain is a rare but significant cause of postoperative morbidity after inguinal surgery. Such pain is usually of neuropathic origin and frequently caused by intraoperative nerve damage. In this retrospective matched-pair study we analysed results of a minimal-invasive approach to neurectomy on quality of life and pain relief. METHODS: From March 2010 to January 2012, 9 patients developing chronic neuropathic pain after inguinal hernia repair (8 patients) or open appendicectomy (one patient) were operated using a laparoscopic transabdominal approach in our department. Clinical examinations and specific questionnaires on pain and quality of life (PainDetect, SF-36) were completed 6 months to 3 years after neurectomy. Every patient was matched with one patient without chronic pain. RESULTS: Seven of nine patients had severe or very severe pain before neurectomy, two had mild pain but refused a conservative treatment. Four patients were free of pain after neurectomy, three described an improved pain status, whereas two did not observe any change in pain. Within a follow-up period of 14,3 months, no deterioration of pain or other complications were observed. Patients who underwent neurectomy had significantly lower quality of life compared to the control group. No postoperative complications were observed. CONCLUSIONS: Laparoscopic transabdominal neurectomy represents a possible surgical approach in treating patients with chronic disabling postoperative groin pain requiring surgery. This technique was feasible, safe, and effective in our series to relieve chronic debilitating pain in the majority of our patients with comparable results to other published approaches.

Quality of Life and Timing of Stoma Closure in Patients With Rectal Cancer Undergoing Low Anterior Resection With Diverting Stoma: A Multicenter Longitudinal Observational Study.

BACKGROUND: After low anterior resection for rectal cancer, creation of a diverting stoma is recommended. Data on the impact of a diverting stoma on quality of life are conflicting. Optimal timing of stoma closure in the setting of adjuvant chemotherapy is unclear. OBJECTIVE: The purpose of this study was to investigate the impact of a diverting stoma on quality of life in patients undergoing rectal cancer resection before and after stoma closure. Furthermore, the study was conducted to look at the timing of stoma reversal and the potential influence of factors such as adjuvant chemotherapy. DESIGN: This was a longitudinal, observational, multicenter study. SETTINGS: The study was conducted at 17 German colorectal centers. PATIENTS: Patients with rectal cancer who planned for elective curative surgery with creation of temporary diverting stoma were included. MAIN OUTCOME MEASURES: This longitudinal observational study assessed quality of life at 3 occasions using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire/Colorectal Cancer Module before cancer resection, before stoma closure, and 6 months after stoma closure. Furthermore, the timing of stoma closure and continence were evaluated. RESULTS: A total of 120 patients (64% men; mean age, 63.2 ± 11.5 years) were analyzed. Longitudinal global quality of life was not influenced by the presence of a stoma. Several functional and GI symptom scales were markedly impaired after stoma creation. Physical, role functioning, and sexual interest recovered after stoma closure. Social functioning stayed impaired (p < 0.0001). Median time to stoma closure was 5 months (range, 17 days to 18 months). A total of 3.4% of patients had very early stoma closure (within 30 days). Adjuvant chemotherapy delayed stoma closure (median, 5.6 vs 3.4 months without chemotherapy; p = 0.0001). LIMITATIONS: The study was limited by its missing quality-of-life data for sexual function. CONCLUSIONS: The presence of a stoma had a negative impact on social functioning and GI symptoms. However, this had no clinically relevant influence on global quality of life. Time to stoma closure was nearly doubled when patients underwent adjuvant chemotherapy.

CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer.

BACKGROUND: Current evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage. However, relevant stoma morbidity after rectal cancer surgery exists and has a significant impact on quality of life. Moreover, a diverting stoma has an influence on completeness of chemotherapy but it remains unclear in which way. There is no evidence regarding optimal timing for stoma closure in relation to adjuvant chemotherapy. Two randomised controlled trials have studied early stoma closure after low anterior resection in patients with rectal cancer, one of them showing that early closure around day 8 after resection is possible without increasing morbidity. METHODS/DESIGN: CoCStom is a randomised multicentre trial comparing completeness of adjuvant chemotherapy as primary endpoint after early (8-10 days after resection, before starting adjuvant therapy) versus late (~26 weeks after resection and completion of adjuvant therapy) stoma closure in patients with locally advanced rectal cancer undergoing low anterior resection after neoadjuvant therapy. After exclusion of post-operative anastomotic leakage 257 patients from 30 German hospitals are planned to be included in order to assure a power of 80% for the confirmatory analysis of at least 214 evaluable cases. An absolute increase of 20% for the rate of completely administered adjuvant chemotherapy is regarded as a clinically meaningful step forward and serves as basis for sample size calculation. Quality of life, stoma-related complications, individual completeness of chemotherapy rate, percentage of patients stopping adjuvant therapy or undergoing dose modifications or delay, oncological outcomes, cumulative days of hospitalisation and number of readmissions, rate of symptomatic anastomotic leaks after stoma closure, mortality, post-operative complications and toxicity of adjuvant chemotherapy are secondary endpoints. DISCUSSION: The CoCStom trial aims to clarify optimal timing of stoma closure in the context of adjuvant chemotherapy. Depending on the results of the trial, patients could benefit either from early or late stoma closure in regard to long term oncological survival due to a higher rate of completeness of adjuvant chemotherapy treatment and thus better effectiveness. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00005113. Registered 28 August 2013.

Effect on the tensile strength of human acellular dermis (Epiflex®) of in-vitro incubation simulating an open abdomen setting.

BACKGROUND: The use of human acellular dermis (hAD) to close open abdomen in the treatment process of severe peritonitis might be an alternative to standard care. This paper describes an investigation of the effects of fluids simulating an open abdomen environment on the biomechanical properties of Epiflex® a cell-free human dermis transplant. METHODS: hAD was incubated in Ringers solution, blood, urine, upper gastrointestinal (upper GI) secretion and a peritonitis-like bacterial solution in-vitro for 3 weeks. At day 0, 7, 14 and 21 breaking strength was measured, tensile strength was calculated and standard fluorescence microscopy was performed. RESULTS: hAD incubated in all five of the five fluids showed a decrease in mean breaking strength at day 21 when compared to day 0. However, upper GI secretion was the only incubation fluid that significantly reduced the mechanical strength of Epiflex after 21 days of incubation when compared to incubation in Ringer's solution. CONCLUSION: hAD may be a suitable material for closure of the open abdomen in the absence of upper GI leakage and pancreatic fistulae.

Motivational Interviewing improves postoperative nutrition goals within the Enhanced Recovery after Surgery (ERAS®) pathway in elective bowel surgery - A randomized clinical pilot trial.

BACKGROUND & AIMS: Exploration whether Motivational Interviewing (MI) could be learned and implemented with ease within a surgical in-hospital setting and whether participation in the intervention led to significantly higher compliance with ERAS®-recommended protein intake goals. The individual healing process of many patients is delayed because they fail to cover their calorie requirement, which could be counteracted by a patient-centered conversational intervention that is new in perioperative practice. METHODS: This patient-blinded pilot-RCT included 60 patients (≥18 years) following the certified ERAS® bowel protocol for colorectal surgery between March and August 2022. Five perioperative MI interventions were conducted by two health employees certified to perform MI. Key endpoints were the number of protein shakes drunk, calories of proteins ingested and overall calorie intake. RESULTS: A total of 60 patients (34 men [56.7%]; mean [SD] age, 60.7 [13.3] years) were randomized. MI patient-group had significantly higher protein shake intake on all postoperative days except day 3. For days 0-3 MI group drank significantly more shakes overall (median 5.5 vs. 2.0; P = 0.004) and consumed more calories (median 1650.0 vs. 600.0 kcal; P = 0.004) and proteins (median 110.0 vs. 40.0 g; P = 0.005). Total calorie intake for each day by shakes and dietary intake was significantly higher in the MI-intervention group on day 2 (mean 1772.3 vs. 1358.9 kcal; P = 0.03). CONCLUSIONS: MI may contribute to improve compliance with nutritional goals in the certified ERAS® protocol by increasing protein and calorie intake. The findings suggest further investigation of MI to help patients achieve their perioperative nutrition goals in different clinical settings. TRIAL REGISTRATION: DRKS - Deutsches Register Klinischer Studien; DRKS-ID: DRKS00027863; https://drks.de/search/de/trial/DRKS00027863.

Intraoperative Wound Irrigation for the Prevention of Surgical Site Infection After Laparotomy: A Randomized Clinical Trial by CHIR-Net.

Importance: Surgical site infections frequently occur after open abdominal surgery. Intraoperative wound irrigation as a preventive measure is a common practice worldwide, although evidence supporting this practice is lacking. Objective: To evaluate the preventive effect of intraoperative wound irrigation with polyhexanide solution. Design, Setting, and Participants: The Intraoperative Wound Irrigation to Prevent Surgical Site Infection After Laparotomy (IOWISI) trial was a multicenter, 3-armed, randomized clinical trial. Patients and outcome assessors were blinded to the intervention. The clinical trial was conducted in 12 university and general hospitals in Germany from September 2017 to December 2021 with 30-day follow-up. Adult patients undergoing laparotomy were eligible for inclusion. The main exclusion criteria were clean laparoscopic procedures and the inability to provide consent. Of 11 700 screened, 689 were included and 557 completed the trial; 689 were included in the intention-to-treat and safety analysis. Interventions: Randomization was performed online (3:3:1 allocation) to polyhexanide 0.04%, saline, or no irrigation (control) of the operative wound before closure. Main Outcome and Measures: The primary end point was surgical site infection within 30 postoperative days according to the US Centers for Disease Control and Prevention definition. Results: Among the 689 patients included, 402 were male and 287 were female. The median (range) age was 65.9 (18.5-94.9) years. Participants were randomized to either wound irrigation with polyhexanide (n = 292), saline (n = 295), or no irrigation (n = 102). The procedures were classified as clean contaminated in 92 cases (8%). The surgical site infection incidence was 11.8% overall (81 of 689), 10.6% in the polyhexanide arm (31 of 292), 12.5% in the saline arm (37 of 295), and 12.8% in the no irrigation arm (13 of 102). Irrigation with polyhexanide was not statistically superior to no irrigation or saline irrigation (hazard ratio [HR], 1.23; 95% CI, 0.64-2.36 vs HR, 1.19; 95% CI, 0.74-1.94; P = .47). The incidence of serious adverse events did not differ among the 3 groups. Conclusions and Relevance: In this study, intraoperative wound irrigation with polyhexanide solution did not reduce surgical site infection incidence in clean-contaminated open abdominal surgical procedures compared to saline or no irrigation. More clinical trials are warranted to evaluate the potential benefit in contaminated and septic procedures, including the emergency setting. Trial Registration: drks.de Identifier: DRKS00012251.

Quality of life of patients after low anterior, intersphincteric, and abdominoperineal resection for rectal cancer--a matched-pair analysis.

PURPOSE: Limits for sphincter preservation in rectal cancer have been expanded under the assumption that patients with a permanent colostomy have worse quality of life (QoL). Incontinence and painful defecation are common problems; therefore, this study compares functional outcome and QoL after sphincter-sparing intersphincteric resection (ISR), low anterior resection (LAR), and abdominoperineal resection (APR) for rectal cancer. METHODS: From a prospective database, three matched groups of patients after surgery for rectal cancer between 1999 and 2009 were extracted. Median follow-up was 59 months. Of 131 patients receiving a questionnaire, 95 % could be analyzed further. Generic and disease-specific validated QoL (European Organization for Research and Treatment in Cancer QLQ-C30, CR38) and Wexner incontinence score were used. RESULTS: Global QoL was comparable between the groups. Physical functioning was significantly better after sphincter preservation surgery than APR (p < 0.05). Symptom scores for diarrhea (DIA) and constipation (CON) were higher after sphincter-preserving surgery (ISR: DIA 45.4, CON 20.2; LAR: DIA 34.1, CON 25.2) compared to APR (DIA 16.6, CON 12.0) (p < 0.05 and <0.01, respectively). Disease-specific QoL assessment showed significantly worse QoL regarding to male sexual function after APR (80.8) than after ISR (53.6) (p < 0.005). Regarding defecation, the ISR group showed significantly higher symptom scores than patients after LAR (p < 0.05). Wexner scores were significantly higher after ISR (12.9) than after LAR (9.5) (p < 0.005).