Lessons Learned from Telemonitoring in an Outpatient Bariatric Surgery Pathway-Secondary Outcomes of a Patient Preference Clinical Trial

Background: Remote monitoring is increasingly used to support postoperative care. This study aimed to describe the lessons learned from the use of telemonitoring in an outpatient bariatric surgery pathway. Materials and Methods: Patients were assigned based on their preference to an intervention cohort of same-day discharge after bariatric surgery. In total, 102 patients were monitored continuously for 7 days using a wearable monitoring device with a Continuous and Remote Early Warning Score–based notification protocol (CREWS). Outcome measures included missing data, course of postoperative heart and respiration rate, false positive notification and specificity analysis, and vital sign assessment during teleconsultation. Results: In 14.7% of the patients, data for heart rate was missing for &gt; 8 h. A day-night-rhythm of heart rate and respiration rate reappeared on average on postoperative day 2 with heart rate amplitude increasing after day 3. CREWS notification had a specificity of 98%. Of the 17 notifications, 70% was false positive. Half of them occurred between day 4 and 7 and were accompanied with surrounding reassuring values. Comparable postoperative complaints were encountered between patients with normal and deviated data. Conclusion: Telemonitoring after outpatient bariatric surgery is feasible. It supports clinical decisions, however does not replace nurse or physician care. Although infrequent, the false notification rate was high. We suggested additional contact may not be necessary when notifications occur after restoration of circadian rhythm or when surrounding reassuring vital signs are present. CREWS supports ruling out serious complications, what may reduce in-hospital re-evaluations. Following these lessons learned, increased patients’ comfort and decreased clinical workload could be expected. Trial Registration: ClinicalTrials.gov. Identifier: NCT04754893. Graphical Abstract: [Figure not available: see fulltext.]</p

A consecutive series of 235 epigastric hernias

Abstract Background Epigastric herniation is a common, though not always symptomatic condition. It is likely, that in accordance to the tension-free principles for other hernias, epigastric hernia repair should be mesh based. Methods Patients from two large hospitals were investigated retrospectively if they were operated on an epigastric hernia for the past 6 years. Follow-up was completed with a postal questionnaire. Results A total of 235 patients (50 % male) were operated. Sixty-eight patients were operated with mesh and 167 patients with suture repair. Forty-six patients were loss-to follow-up (19.6 %). In the mesh operated patients the recurrence rate was 10.9 % (n = 6) compared to 14.9 % (n = 20) in the suture repair group. Cox-regression analysis showed an increased risk for recurrence in the suture repair group (odds ratio 1.43; 95 % CI 0.56-3.57; p = 0.44). Operation time for mesh repair (47 min) was significantly longer compared to suture repair (29 min) (p \ 0.0001). Thirty-seven patients had previous or other anterior wall hernias. A total of 51 patients smoked and 14 patients had diabetes mellitus. Fourteen patients used steroids and 22 patients suffered from a chronic lung disease. Subgroup analysis showed a significant difference for pain in patients in which re-operation for a recurrence occurred (p = 0.004). Conclusions This is one of the largest reported series on solely epigastric hernias. A recurrence occurred more often after sutured repair compared to mesh repair. No differences in chronic pain was seen between mesh and suture repaired patients. Male:female ratio of 1:1, which is different from the 3:1 ratio found in previous older smaller studies, could be more reliable

Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial

Background: The peritoneum is the second most common site of recurrence in colorectal cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult. Patients eventually presenting with clinically apparent PC have a poor prognosis. Median survival is only about five months if untreated and the benefit of palliative systemic chemotherapy is limited. Only a quarter of patients are eligible for curative treatment, consisting of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC). However, the effectiveness depends highly on the extent of disease and the treatment is associated with a considerable complication rate. These clinical problems underline the need for effective adjuvant therapy in high-risk patients to minimize the risk of outgrowth of peritoneal micro metastases. Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) seems to be suitable for this purpose. Without the need for cytoreductive surgery, adjuvant HIPEC can be performed with a low complication rate and short hospital stay. Methods/Design: The aim of this study is to determine the effectiveness of adjuvant HIPEC in preventing the development of PC in patients with colon cancer at high risk of peritoneal recurrence. This study will be performed in the nine Dutch HIPEC centres, starting in April 2015. Eligible for inclusion are patients who underwent curative resection for T4 or intra-abdominally perforated cM0 stage colon cancer. After resection of the primary tumour, 176 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously or shortly after the primary resection. Oxaliplatin will be used as chemotherapeutic agent, for 30 min at 42-43 degrees C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA. Discussion: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to translate into a prolonged overall survival

The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitisA and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitisB in perforated diverticulitis (NTR2037)

Background: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). Methods/Design: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and powe

Outcomes of the first global multidisciplinary consensus meeting including persons living with obesity to standardize patient-reported outcome measurement in obesity treatment research

Quality of life is a key outcome that is not rigorously measured in obesity treatment research due to the lack of standardization of patient-reported outcomes (PROs) and PRO measures (PROMs). The S.Q.O.T. initiative was founded to Standardize Quality of life measurement in Obesity Treatment. A first face-to-face, international, multidisciplinary consensus meeting was conducted to identify the key PROs and preferred PROMs for obesity treatment research. It comprised of 35 people living with obesity (PLWO) and healthcare providers (HCPs). Formal presentations, nominal group techniques, and modified Delphi exercises were used to develop consensus-based recommendations. The following eight PROs were considered important: self-esteem, physical health/functioning, mental/psychological health, social health, eating, stigma, body image, and excess skin. Self-esteem was considered the most important PRO, particularly for PLWO, while physical health was perceived to be the most important among HCPs. For each PRO, one or more PROMs were selected, except for stigma. This consensus meeting was a first step toward standardizing PROs (what to measure) and PROMs (how to measure) in obesity treatment research. It provides an overview of the key PROs and a first selection of the PROMs that can be used to evaluate these PROs

Telemonitoring for perioperative care of outpatient bariatric surgery: Preference-based randomized clinical trial.

ImportanceImplementation of bariatric surgery on an outpatient basis is hampered by concerns about timely detection of postoperative complications. Telemonitoring could enhance detection and support transition to an outpatient recovery pathway.ObjectiveThis study aimed to evaluate non-inferiority and feasibility of an outpatient recovery pathway after bariatric surgery, supported by remote monitoring compared to standard care.DesignPreference-based non-inferiority randomized trial.SettingCenter for obesity and metabolic surgery, Catharina hospital Eindhoven, the Netherlands.ParticipantsAdult patients scheduled for primary gastric bypass or sleeve gastrectomy.InterventionsSame-day discharge with one week ongoing Remote Monitoring (RM) of vital parameters or Standard Care (SC) with discharge on postoperative day one.Main outcomesPrimary outcome was a thirty-day composite Textbook Outcome score encompassing mortality, mild and severe complications, readmission and prolonged length-of-stay. Non-inferiority of same-day discharge and remote monitoring was accepted below the selected margin of 7% upper limit of confidence interval. Secondary outcomes included admission duration, post-discharge opioid use and patients' satisfaction.ResultsTextbook Outcome was achieved in 94% (n = 102) in RM versus 98% (n = 100) in SC (RR 2.9; 95% CI, 0.60-14.23, p = 0.22). The non-inferiority margin was exceeded which is a statistically inconclusive result. Both Textbook Outcome measures were above Dutch average (5% RM and 9% SC). Same-day discharge reduced hospitalization days by 61% (pConclusionIn conclusion, outpatient bariatric surgery supported with telemonitoring is clinically comparable to standard overnight bariatrics in terms of textbook-outcome. Both approaches reached primary endpoint results above Dutch average. However, statistically the outpatient surgery protocol was neither inferior, nor non-inferior to the standard pathway. Additionally, offering same-day discharge reduces the total hospitalization days while maintaining patient satisfaction and safety