Primary Care Disease Management for Venous Leg Ulceration in German Healthcare: Results of the Ulcus Cruris Care Pilot Study.

Despite proven effectiveness, compression therapy is applied in only 20-40% of patients with venous leg ulceration, leading to avoidable chronification and morbidity. The Ulcus Cruris Care project was established to develop a new disease-management concept comparable to existing programs for chronic diseases to support evidence-based treatment of venous leg ulceration. This prospective controlled study assessed its first implementation. Interventional elements comprised online training for general practitioner practices, software support for case management, and educational materials for patients. A total of 20 practices and 40 patients were enrolled in a 1:1 ratio to the intervention and control group. Guideline-conform compression therapy was applied more frequently in the intervention group (19/20 [95%] vs. 11/19 [58%]; p = 0.006). For patients with ulcers existing ≤ 6 months, the healing rate at 12 weeks was 8/11 [73%] (intervention) compared to 4/11 [36%] (control; p = 0.087). Patients after intervention had higher scores for self-help and education in the PACIC-5A questionnaire (42.9 ± 41.6 vs. 11.4 ± 28.8; p = 0.044). Treatment costs were EUR 1.380 ± 1.347 (intervention) and EUR 2.049 ± 2.748 (control; p = 0.342). The results of this study indicate that the Ulcus Cruris Care intervention may lead to a significant improvement in care. Consequently, a broader rollout in German healthcare seems warranted.

Exploring healthcare provider and patient perspectives on current outpatient care of venous leg ulcers and potential interventions to improve their treatment: a mixed methods study in the ulcus cruris care project.

BACKGROUND: The project "Ulcus Cruris Care" aims to improve primary care for patients with venous leg ulcer (VLU) in General Practitioner (GP) practices using a complex intervention comprised of educational components, standardized treatment recommendations, computer-assisted documentation, and case management by non-physician medical assistants (MAs). Prior to implementing and testing the intervention components in general practices, in-depth exploration of current outpatient treatment of VLU patients and relevant implementation determinants was pursued. METHODS: A mixed-methods study explored views of GPs, MAs, and patients regarding current VLU outpatient care and the planned intervention components to identify potential implementation determinants. Data were collected through semi-structured guide-based telephone interviews (n = 29) and a survey questionnaire (n = 28). Interviews were transcribed verbatim. Analysis was inductive initially and finalized in a deductive-inductive approach based on domains of the Theoretical Domains Framework to support structuring of relevant implementation determinants. Survey data were analyzed descriptively. RESULTS: Current VLU outpatient care was described as frequently tailored to individual wounds and gradient. In general, workload was shared by GPs (diagnostics, counselling) and MAs (wound care). All care providers were aware of compression therapy, yet not all of them considered it essential for VLU care. Standardized operating procedures and educational components including e-learning were considered supportive. Stronger involvement of non-physician assistants was seen as opportunity to optimize VLU care. Concerns were identified regarding integration of software-supported case management into daily practice routines and regarding potential limitations in decision-making autonomy when using standard operating procedures. CONCLUSIONS: Findings in this study emphasize a need for educational interventions addressing VLU care providers as well as patients, particularly with regards to compression therapy. The conception of the planned intervention appears to be adequate and a structured guideline-based case management might be a promising approach for optimization of VLU treatment.

How can competencies in minor surgery in general practice be increased? Assessing the effect of a compact intervention in postgraduate training: a mixed-methods study.

OBJECTIVES: We aimed to assess general practice (GP) trainees' self-perception of surgical competencies and to explore longitudinal effects of a compact intervention. DESIGN: We performed a mixed-methods study including a before and after comparison in the intervention group (IG), a comparison of attendees and non-attendees (control group (CG)) and a qualitative evaluation of the intervention. Competencies were self-assessed through surveys. Semi-structured interviews were performed after 9 months. SETTING: In 2019, a 2-day voluntary seminar focussing on minor surgery/injuries was offered on 13 occasions by educators from KWBW Verbundweiterbildungplus (Competence Centre for Postgraduate Medical Education Baden-Württemberg). PARTICIPANTS: All enrolled GP trainees were offered participation. GP trainees who did not attend a seminar (non-attendees) were recruited for CG after the 13th intervention. INTERVENTION: Attendees took part in an interactive, GP-oriented short course incorporating 270 min of focused minor surgery/injuries training (compact intervention) on the second day of the 2-day seminar. RESULTS: 326 GP trainees (IG: n=257; CG: n=69) participated in the study. 17 attendees were interviewed. CG had more often experienced a surgical rotation (p=0.03) and reported higher interest in performing minor surgery in future practice (p=0.03). GP trainees self-rated their all-round competency in minor surgery as average (IG: 3.0±1.0, CG: 3.2±0.9, IG:CG p=0.06). After the intervention, attendees felt that surgical skills should be a core component of GP vocational training (p=0.05). After 9 months, attendees remembered a variety of content and valued the interactive, case-oriented, peer-to-peer approach in a mixed learning group. Some attendees reported they had started to overcome competency gaps in minor surgery. CONCLUSIONS: A compact intervention in minor surgery provides an 'intense' stimulus which could foster positive attitudes towards minor surgery and promote longitudinal personal development of related competencies in GP trainees, including those with little interest in surgery. Such measures appear crucial to support individual progress of GP trainees to provide comprehensive primary care.

Need for nursing care after laparoscopic and open colorectal cancer surgery: a claims data analysis in German primary care.

PURPOSE: Our study analyzes the influence of minimally invasive vs. open surgery on the postoperative need for nursing care in patients with colorectal carcinoma. Colorectal cancer is an age-related disease, and oncologic surgery is increasingly performed in elderly patients. Long-term effects of the procedural choice on patients' self-sufficiency and autonomy have not been scientifically addressed so far. METHODS: Multivariable logistic regression models based on claims data from a statutory health insurer (AOK, Baden-Württemberg, Germany) were applied to assess potential risk factors for assignment patients to a nursing care level, a German scale to categorize individual need for nursing care, at 12 and 36 months after colorectal cancer surgery. RESULTS: A total of 3996 patients were eligible to be included in the analysis. At 36 months postoperatively, 44 of 427 (10.3%) patients after minimally invasive colon cancer surgery and 231 of 1287 (17.9%) patients after open procedure were newly graded into a nursing care level (OR = 0.62, 95%CI = 0.44-0.90, p = 0.010). Thirty-four of 251 (13.5%) patients receiving minimally invasive rectal cancer surgery compared to 142 of 602 (23.6%) patients after open approach were newly assigned to a nursing care level (OR = 0.53, 95%CI = 0.34-0.81, p = 0.003). CONCLUSIONS: Laparoscopically assisted resection of colorectal cancer seems to be superior in preserving physical autonomy of elderly patients with colorectal cancer.

Primary care disease management for venous leg ulceration-study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126).

BACKGROUND: Venous leg ulcers (VLU) have a prevalence of 1-2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation. Evidence-based outpatient treatment based on compression therapy is frequently not implemented. The "Ulcus Cruris Care" project was established to develop a disease management concept to improve outpatient treatment for patients with VLU in German primary care. For this purpose, a multifaceted intervention was conceived consisting of an online training for general practitioners and medical assistants, standardized treatment recommendations, e-learning and print-based information for patients, and a software support for case management. The main aims of the Ulcus Cruris Care intervention are to promote standardized treatment according to current scientific knowledge, to facilitate case management for VLU patients exerted by medical assistants, and to support patient education and participation in the treatment process. The UCC trial was designed to evaluate the effectiveness of the Ulcus Cruris Care intervention. METHODS: The UCC trial is a prospective cluster-randomized controlled multicenter trial. Fifty GP practices are intended to be recruited and randomized 1:1 to intervention or control arm. Patients with venous leg ulcers will be recruited by participating GP practices, to include a total of 63 patients in each arm. The primary outcome is time to ulcer healing. Secondary outcomes comprise number and sizes of ulcers, recurrence, pain intensity according to the visual analog scale, health-related quality of life according to EQ-5D-5L, depressiveness according to Patient Health Questionnaire (PHQ-9), patient satisfaction according to the Patient Assessment of Chronic Illness Care (PACIC-5A) query, and adherence to VLU treatment. The outcome analysis of the UCC trial is accompanied by a health economic analysis and a process evaluation. DISCUSSION: The UCC trial will evaluate whether the Ulcus Cruris Care intervention may lead to faster wound healing, higher health-related quality of life, and lower use of medical resources. If the intervention turns out to have a positive impact on assessed outcomes, comprehensive implementation in primary care may be considered. TRIAL REGISTRATION: The trial protocol (version 1 as of July 19, 2021) has been registered in the German Clinical Trials Register on August 30, 2021 ( DRKS00026126 ).

Primary care practice-based care management for chronically ill patients (PraCMan) in German healthcare: Outcome of a propensity-score matched cohort study.

BACKGROUND: Growing prevalence of chronic diseases is a rising challenge for healthcare systems. The Primary Care Practice-Based Care Management (PraCMan) programme is a comprehensive disease management intervention in primary care in Germany aiming to improve medical care and to reduce potentially avoidable hospitalisations for chronically ill patients. OBJECTIVES: This study aimed to assess the effect of PraCMan on hospitalisation rate and related costs. METHODS: A retrospective propensity-score matched cohort study was performed. Reimbursement data related to patients treated in general practices between 1st July 2013 and 31st December 2017 were supplied by a statutory health insurance company (AOK Baden-Wuerttemberg, Germany) to compare hospitalisation rate and direct healthcare costs between patients participating in the PraCMan intervention and propensity-score matched controls following usual care. Outcomes were determined for the one-year-periods before and 12 months after beginning of participation in the intervention. RESULTS: In total, 6148 patients participated in the PraCMan intervention during the observation period and were compared to a propensity-score matched control group of 6148 patients from a pool of 63,446 eligible patients. In the one-year period after the intervention, the per-patient hospitalisation rate was 8.3% lower in the intervention group compared to control (p = 0.0004). Per-patient hospitalisation costs were 9.4% lower in favour of the intervention group (p = 0.0002). CONCLUSION: This study showed that the PraCMan intervention may be associated with a lower rate of hospital admissions and hospitalisation costs than usual care. Further studies may assess long-term effects of PraCMan and its efficacy in preventing known complications of chronic diseases.

Effect of involving certified healthcare assistants in primary care in Germany: a cross-sectional study.

OBJECTIVES: Growing prevalence of chronic diseases and limited resources are the key challenges for future healthcare. As a promising approach to maintain high-quality primary care, non-physician healthcare professionals have been trained to broaden qualifications and responsibilities. This study aimed to assess the influence of involving certified healthcare assistants (HCAs, German: Versorgungsassistent/in in der Hausarztpraxis) on quality and efficacy of primary care in Germany. DESIGN: Cross-sectional study. SETTING: Primary care. PARTICIPANTS: Patients insured by the Allgemeine Ortskrankenkasse (AOK) statutory health insurer (AOK, Baden-Wuerttemberg, Germany). INTERVENTIONS: Since 2008 practice assistants in Germany can enhance their professional education to become certified HCAs. PRIMARY AND SECONDARY OUTCOME MEASURES: Claims data related to patients treated in practices employing at least one HCA were compared with data from practices not employing HCAs to determine frequency of consultations, hospital admissions and readmissions. Economic analysis comprised hospitalisation costs, prescriptions of follow-on drugs and outpatient medication costs. RESULTS: A total of 397 493 patients were treated in HCA practices, 463 730 patients attended to non-HCA practices. Patients in HCA practices had an 8.2% lower rate of specialist consultations (p<0.0001), a 4.0% lower rate of hospitalisations (p<0.0001), a 3.5% lower rate of readmissions (p=0.0463), a 14.2% lower rate of follow-on drug prescriptions (p<0.0001) and 4.7% lower costs of total medication (p<0.0001). No difference was found regarding the consultation rate of general practitioners and hospital costs. CONCLUSIONS: For the first time, this high-volume claims data analysis showed that involving HCAs in primary care in Germany is associated with a reduction in hospital admissions, specialist consultations and medication costs. Consequently, broadening qualifications may be a successful strategy not only to share physicians' work load but to improve quality and efficacy in primary care to meet future challenges. Future studies may explore specific tasks to be shared with non-physician workforces and standardisation of the professional role.

Contamination After Disinfectant Rectal Washout in Left Colectomy as a Model for Transrectal NOTES: A Randomized Controlled Trial.

BACKGROUND: In natural orifice transluminal endoscopic surgery (NOTES) with transrectal (TR) access the intraoperative opening of the rectal wall poses a risk of intraperitoneal contamination and subsequent infectious complications. A rectal washout with a disinfectant may reduce this risk. The aim of the study was to assess the intraoperative contamination on the circular stapler pin when a rectal washout with povidone-iodine (RW-PI) or Ringer solution was performed in patients undergoing left-sided colectomy. Furthermore, the additional effect of an irrigation instrument on the contamination was evaluated. METHODS: In a patient and assessor blinded randomized controlled trial, patients undergoing left-sided colectomy were assigned to rectal washout with PI with an irrigation instrument (RW-PI; n = 23), rectal washout with Ringer solution with an irrigation instrument (RW-R; n = 21) or rectal washout with Ringer solution without an irrigation instrument (RW; n = 25). An end-to-end anastomosis with a circular stapler was performed. The contamination on the pin of the circular stapler was chosen as primary endpoint in order to simulate the intraabdominal contamination risk during TR NOTES. Secondary endpoints were contamination of the rectal mucosa, peritoneal contamination and postoperative morbidity. RESULTS: The contamination rate of the pin of the circular stapler did not differ (RW-PI 39.1%, RW-R 33.3%, RW 52.0%; P = 0.421), but contamination of the rectal mucosa was reduced (47.8% versus 95.2% versus 100%; P < 0.001) and peritoneal contamination tended to be reduced (39.1% versus 71.4% versus 60.0%; P = 0.09) when a rectal washout with PI was performed. The rates of infectious complications (17.4% versus 9.5% versus 12.0%; P = 0.821) and of overall complications (30.4% versus 28.6% versus 44.0%; P = 0.476) did not differ. CONCLUSIONS: Despite an intense rectal washout with PI, contamination of the stapler pin did not differ. Intraabdominal bacterial translocation was frequently encountered even after disinfectant rectal washout with PI. Further studies might focus on the clinical impact of intraabdominal contamination in TR NOTES.

Inflammatory response and peritoneal contamination after transrectal natural orifice specimen extraction (NOSE) versus mini-laparotomy: a porcine in vivo study.

BACKGROUND: Transrectal natural orifice specimen extraction (NOSE) avoids abdominal organ retrieval during laparoscopic procedures and may reduce surgical trauma. However, this has not been proven clinically and transrectal peritoneal contamination is feared to cause infectious complications. This experimental study was designed to evaluate inflammatory response and peritoneal contamination after transrectal NOSE versus mini-laparotomy. METHODS: 24 German Landrace pigs underwent transrectal NOSE (N = 12) or mini-laparotomy (N = 12) for standardized extraction of water-instilled balloon. Blood samples were taken for analysis of leucocytes, CRP, IL-6, IL-10, and TNFα at 6, 12, 24, 48, 72 h as well as 7 and 14 days postoperatively. After 14 days laparoscopy was performed to inspect the abdomen and for microbiological swab sampling. RESULTS: Leucocytes were higher in the NOSE group at 72 h (19.3 ± 3.9/nl vs. 15.8 ± 4.2/nl, p = 0.046). IL-6 was lower in the NOSE group at day 7 (165 ± 100/nl vs. 306 ± 70/nl, p = 0.030). No difference was found comparing inflammatory parameters at all other time points. No difference was found regarding peritoneal contamination, which was 58.3% (7/12) in the NOSE group and 41.7% (5/12) in the MiniLap group (p = 0.414). CONCLUSIONS: The results suggest a pronounced acute inflammatory response after transrectal NOSE compared to mini-laparotomy, while late cytokine response seems to be less after transrectal NOSE, which may reflect less intense wound healing process. Using standardized rectal decontamination and endolumenal colon occlusion transrectal NOSE seems to be safe and comparable to mini-laparotomy with regard to peritoneal contamination. Clinical evidence is needed now to weight transrectal NOSE against mini-laparotomy during laparoscopic surgery.

Transrectal rigid-hybrid NOTES cholecystectomy can be performed without peritoneal contamination: a controlled porcine survival study.

BACKGROUND AND STUDY AIMS: The risk of infectious complications due to peritoneal contamination is a major concern and inhibits the widespread use of transrectal NOTES. A standardized rectal washout with a reversible colon occlusion device in situ has previously shown potential in reducing peritoneal contamination. The aim of this study was to compare the peritoneal contamination rate and inflammatory reaction for transrectal cholecystectomy after ideal rectal preparation (trCCE) and standard laparoscopic cholecystectomy (lapCCE) in a porcine survival experiment. METHODS: Twenty pigs were randomized to trCCE (n = 10) or lapCCE (n = 10). Before trCCE, rectal washout was performed with saline solution. A colon occlusion device was then inserted and a second washout with povidone-iodine was performed. The perioperative course and the inflammatory reaction (leukocytes, C-reactive protein) were compared. At necropsy, 14 days after surgery the abdominal cavity was screened for infectious complications and peritoneal swabs were obtained for comparison of peritoneal contamination. RESULTS: Peritoneal contamination was lower after trCCE than after lapCCE (0/10 vs. 6/10; p = 0.003). No infectious complications were found at necropsy in either group and postoperative complications did not differ (p = 1.0). Immediately after the procedure, leukocytes were higher after lapCCE (17.0 ± 2.7 vs. 14.6 ± 2.3; p = 0.047). Leukocytes and C-reactive protein showed no difference in the further postoperative course. Intraoperative complications and total operation time (trCCE 114 ± 32 vs. 111 ± 27 min; p = 0.921) did not differ, but wound closure took longer for trCCE (31.5 ± 19 vs. 13 ± 5 min; p = 0.002). CONCLUSIONS: After standardized rectal washout with a colon occlusion device in situ, trCCE was associated without peritoneal contamination and without access-related infectious complications. Based on the findings of this study, a randomized controlled clinical study comparing clinical outcomes of trCCE with lapCCE should be conducted.

Direct Observation versus Endoscopic Video Recording-Based Rating with the Objective Structured Assessment of Technical Skills for Training of Laparoscopic Cholecystectomy.

PURPOSE: The validated Objective Structured Assessment of Technical Skills (OSATS) score is used for evaluating laparoscopic surgical performance. It consists of two subscores, a Global Rating Scale (GRS) and a Specific Technical Skills (STS) scale. The OSATS has accepted construct validity for direct observation ratings by experts to discriminate between trainees' levels of experience. Expert time is scarce. Endoscopic video recordings would facilitate assessment with the OSATS. We aimed to compare video OSATS with direct OSATS. METHODS: We included 79 participants with different levels of experience [58 medical students, 15 junior residents (novices), and 6 experts]. Performance of a cadaveric porcine laparoscopic cholecystectomy (LC) was evaluated with OSATS by blinded expert raters by direct observation and then as an endoscopic video recording. Operative time was recorded. RESULTS: Direct OSATS rating and video OSATS rating correlated significantly (x03C1; = 0.33, p = 0.005). Significant construct validity was found for direct OSATS in distinguishing between students or novices and experts. Students and novices were not different in direct OSATS or video OSATS. Mean operative times varied for students (73.4 ± 9.0 min), novices (65.2 ± 22.3 min), and experts (46.8 ± 19.9 min). Internal consistency was high between the GRS and STS subscores for both direct and video OSATS with Cronbach's α of 0.76 and 0.86, respectively. Video OSATS and operative time in combination was a better predictor of direct OSATS than each single parameter. CONCLUSION: Direct OSATS rating was better than endoscopic video rating for differentiating between students or novices and experts for LC and should remain the standard approach for the discrimination of experience levels. However, in the absence of experts for direct rating, video OSATS supplemented with operative time should be used instead of single parameters for predicting direct OSATS scores.

New device for transrectal trocar placement and rectal sealing for NOTES: a porcine in vivo and human cadaver study.

BACKGROUND: To date, hybrid NOTES, combining transvaginal and laparoscopic access, represents the most popular clinically applied NOTES approach enabling surgical handling comparable to laparoscopic surgery. The transrectal route could be used in a similar way; however, suitable devices facilitating feasible transrectal access and rectal sealing are lacking. METHODS: In collaboration with Karl Storz GmbH, we tailored a rectoscope and trocars to facilitate transrectal trocar placement and rectal sealing for hybrid NOTES procedures using rigid instruments. Five German Landrace pigs underwent transrectal hybrid NOTES cholecystectomy using the new devices. In a second experiment, the transferability to human anatomy was assessed in a human cadaver. RESULTS: Using the new devices, transrectal trocar placement and rectal sealing proved to be feasible in both experiments. Transrectal hybrid NOTES cholecystectomy could be performed without complications. CONCLUSION: The presented devices provide a tailored operating platform allowing precise transrectal trocar insertion and feasible sealing of the rectotomy. Consequently, these new instruments may pave the way for transrectal hybrid NOTES procedures and could succeed to clinical use in future.

Endolumenal colon occlusion reduces peritoneal contamination during a transrectal NOTES procedure: a controlled porcine survival study.

BACKGROUND: To enable an efficient and enduring decontamination of the rectal mucosa during transanal endosocopic procedures, we developed a device for reversible endolumenal colon occlusion (ColoShield). The aim of this study was to assess the value of ColoShield in reducing peritoneal contamination during a transrectal procedure. METHODS: Sixteen pigs underwent transrectal hybrid NOTES cholecystectomy after standardized disinfective rectal washout either with endolumenal colon occlusion using ColoShield (N = 8) or without colon occlusion (N = 8). Rectal swab samples were taken before and after rectal washout and at the end of the procedure. Peritoneal biopsies for microbiological evaluation were obtained at the end of the procedure and at necropsy 7 days after surgery. RESULTS: Peritoneal contamination at the end of surgery was significantly lower using ColoShield compared to not using colon occlusion [13 (1/8) vs. 75 % (6/8); P = 0.012]. No significant differences were found regarding contamination of rectal swabs and peritoneal contamination at necropsy. CONCLUSION: The application of ColoShield may increase the safety of transrectal NOTES and transanal endoscopic procedures by reducing peritoneal contamination and consecutive infectious complications.

A Retrospective Comparison of Mycophenolate Mofetil with Low-Exposure Cyclosporine Versus Standard Cyclosporine Therapy in De Novo Liver Transplant Patients.

BACKGROUND Data on low-exposure calcineurin inhibitor therapy with mycophenolate mofetil (MMF) in de novo liver transplant patients are limited and restricted to tacrolimus. MATERIAL AND METHODS Twenty-eight patients receiving cyclosporine and MMF at a single center were identified retrospectively and categorized as low-exposure or standard-exposure CsA (median concentration <80 ng/mL [n=16] or ≥80 ng/mL [n=12] during days 1-7) and analyzed to 12 weeks post-transplant. RESULTS Biopsy-proven acute rejection (Banff ≥4) occurred in 3 low-CsA patients and no standard-CsA patients (p=0.238); graft failure occurred in 4 and zero patients, respectively (p=0.113); no graft loss was attributable to rejection. Mean (SD) estimated GFR at baseline and week 12 was 79.5 (45.3) and 79.3 (24.5) mL/min/1.73 m2 in the low-CsA group (p=0.508), and 106.0 (66.9) and 86.7 (23.2) mL/min/1.73 m2 in the standard-CsA group (p=0.093). Estimated GFR decreased significantly in patients with good baseline renal function (≥80 mL/min/1.73 m2) in the standard-CsA (p=0.028) and increased markedly in patients with poor function (≤60 mL/min/1.73 m2) given low-CsA (p=0.043). There was no significant between-group difference regarding incidence of infections. CONCLUSIONS These preliminary findings suggest that immunosuppressive efficacy is maintained with low-exposure CsA and MMF in de novo liver transplant patients and good baseline renal function may be better preserved, but no benefit for infections was observed.

Surgical versus medical treatment of type 2 diabetes mellitus in nonseverely obese patients: a systematic review and meta-analysis.

OBJECTIVE: To compare surgical versus medical treatment of type 2 diabetes mellitus (T2DM) remission and comorbidities in patients with a body mass index (BMI) less than 35 kg/m2. BACKGROUND: Obesity surgery can achieve remission of T2DM and its comorbidities. Metabolic surgery has been proposed as a treatment option for diabetic patients with BMI less than 35 kg/m2 but the efficacy of metabolic surgery has not been conclusively determined. METHODS: A systematic literature search identified randomized (RCT) and nonrandomized comparative observational clinical studies (OCS) evaluating surgical versus medical T2DM treatment in patients with BMI less than 35 kg/m2. The primary outcome was T2DM remission. Additional analyses comprised glycemic control, BMI, HbA1c level, remission of comorbidities, and safety. Random effects meta-analyses were calculated and presented as weighted odds ratio (OR) or mean difference (MD) with 95% confidence intervals (95% CI). RESULTS: Five RCTs and 6 OCSs (706 total T2DM patients) were included. Follow-up ranged from 12 to 36 months. Metabolic surgery was associated with a higher T2DM remission rate (OR: 14.1, 95% CI: 6.7-29.9, P < 0.001), higher rate of glycemic control (OR: 8.0, 95% CI: 4.2-15.2, P < 0.001) and lower HbA1c level (MD: -1.4%, 95% CI -1.9% to -0.9%, P < 0.001) than medical treatment. BMI (MD: -5.5 kg/m2, 95% CI: -6.7 to -4.3 kg/m2, P < 0.001), rate of arterial hypertension (OR: 0.25, 95% CI: 0.12-0.50, P < 0.001) and dyslipidemia (OR: 0.21, 95% CI: 0.10-0.44, P < 0.001) were lower after surgery. CONCLUSION: Metabolic surgery is superior to medical treatment for short-term remission of T2DM and comorbidities. Further RCTs should address the long-term effects on T2DM complications and mortality.

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard. METHODS: The TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle. DISCUSSION: The TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection. TRIAL REGISTRATION: The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.