P354 Early treatment versus active surveillance after ileocolic resection in Crohn’s disease: a retrospective cohort study

Abstract Background Patients with Crohn’s disease (CD) often require ileocolic resection (ICR) due to refractory disease or disease-related complications, such as intestinal strictures, enteric fistulae or intra-abdominal abscesses. Up to 70% of patients will develop new endoscopic lesions in the neoterminal ileum within the first year after surgery. We assessed if the timing of postoperative treatment can reduce postoperative recurrence (POR) rate. Methods We performed a retrospective, single-center observational cohort study in a tertiary hospital. All CD patients undergoing abdominal surgery from January 1st 2015 until June 30th 2019 were screened. Patients with CD who underwent ileocolic resection with ileocolic anastomosis were included. Depending on the postoperative management patients were divided in two groups: “wait and see” if medical treatment was not initiated before endoscopic evaluation 6 months after surgery (n=109), “treat” if medical treatment was initiated directly after surgery (n=49). Patients whose postoperative follow-up occurred in another center were excluded. Data were collected by review of the electronic medical charts and included patient demographics, disease characteristics (Montreal classification), medication, indication for surgery and POR assessment. POR was defined as clinical (PRO2 pain >1 or loose stool frequency >1.5), endoscopic (Rutgeerts score > i2a) or radiologic (disease activity on MR enterography necessitating treatment). Survival analysis was performed with Kaplan-Meier and Cox proportional hazards model. Results In total 158 patients met the inclusion criteria: 109 patients in the “wait and see” group and 49 in the “treat” group. The main baseline characteristics of the cohorts are summarized in figure 1. The main indication for surgery was stricturing disease in both groups (69.7% and 65.3%) followed by penetrating disease (42.2% and 24.5%) and refractory disease (6.4% and 20.4%). Postoperative management did not significantly influence the risk for POR (figure 2). The same was also observed in patients with known risk factors for POR (figure 3). Patients with a high body mass index (>25 kg/m²) had a significant greater risk for developing POR (HR 1.65, CI 1.09-2.5, p=0.019; figure 4). Conclusion There was no statistical significant difference in POR between immediate treatment after ICR and active surveillance with endoscopy 6 months after surgery. Prospective randomized trials with long follow-up are needed to further explore the use of adjuvant postoperative treatment to prevent POR.

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FRI0231 TREATMENT OF DIGITAL ULCERS IN PATIENTS WITH SYSTEMIC SCLEROSIS: PROSPECTIVE COHORT STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3684 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 699.1-699

Author(s):

S. H. Chang ◽

J. B. Jun ◽

Y. J. Lee ◽

T. Y. Kang ◽

Y. Park ◽

...

Keyword(s):

Cohort Study ◽

Systemic Sclerosis ◽

Medical Treatment ◽

Digital Ulcers ◽

Channel Blockers ◽

Treatment Groups ◽

Observational Cohort ◽

The Mean ◽

Clinically Significant

Background:Digital ulcer (DU) is a common clinical manifestation in patients with systemic sclerosis (SSc). About 70% of patients with SSc experience DUs during the first 10 years, which limit daily activities and may result in digital gangrene or amputation. Several vasoactive/vasodilating agents have been suggested for treatment, but few studies have compared the efficacy of those drugs.Objectives:The objective of our study was to compare the efficacy of medical treatment for SSc related-DUs, focusing on on endothelin receptor antagonist (ERA) and phosphodiesterase-5 inhibitors (PDE5inh).Methods:In this prospective observational cohort study, we recruited patients who had one or more active SSc-related DUs and newly started or changed a medical treatment for SSc-related DUs from 13 medical centers in South Korea. The primary outcome was to compare the time to resolution of cardinal DU (CU) according to the treatments. The secondary outcomes included changes in the size or number of CU and changes in the number of DUs. CU was defined as the most clinically significant DU chosen by the investigators. Patients were followed up at every 4 weeks after enrollment until 12 weeks and finally at 24 weeks.Results:Seventy-one patients were enrolled. Seven patients were excluded due to follow-up loss or withdrawal of consent. A total of 64 patients were analyzed. Seventy-eight percent (n=50) were female. The mean age at enrollment was 49.6 ± 11.6 year-old, and the mean disease duration was 7.1 ± 5.9 years. Twenty-eights pateitns (43.8%) were limited SSc. Forty-nine patients (n=76.6%) started ERA treatment (bosentan=49). Eleven patients (17.2%) started PDE5inh treatment (n=9 for sildenafil, n=1 for udenafil, and n=1 for tadalafil). Four patients who started medication other than ERA or PDE5inh classified as other treatment groups. Seventeen patients (26.6%) were on background calcium channel blockers (CCBs). CU healed in 25 patients (39.1%) at 12 weeks and 43 patients (67.2%) at 24 weeks. The mean time to heal CUs were 54.4 ± 22.7 days at 12 weeks and 91.6 ± 49.2 days at 24 weeks. Time to heal CU was comparable among patients on ERA, PDE5inh, and others (p=0.53, figure 1). The CU area was comparable among the three groups at baseline, 12, and 24 weeks. The mean area of CU in patients on ERA at baseline at 12, and 24 weeks was 21.3±19.4 mm2, 8.2±14.6 mm2, and 4.6±7.7 mm2, respectively. The mean area of CU in patients with PDE5inh at baseline at 12, and 24 weeks was 26.2±28.1 mm2, 3.5±3.6 mm2, and 1.3±4.3 mm2. New DUs developed in 4 patients (8.3%) in ERA, whereas 4 patients (40.0%) in PDE5inh at 4 weeks. The use of ERA was significantly associated with less new DUs development than the use of PDE5inh at 4 weeks follow-up (RR for developing new DU patients on ERA, 0.21; 95% CI 0.06-0.70; p=0.02) At 24 weeks follow-up, none of the patients on CCB developed new DUs.Conclusion:The time to heal CU for ERA and PDEinh users was comparable in the current study. ERA treatment was associated with reduced new DU occurrence compared with PDE5inh treatment. None of the patients with CCB treatment developed new DU development at 24 weeks.Acknowledgments:This study was supported by Handok Pharmaceutical Inc., Seoul, Republic of Korea.Disclosure of Interests:Sung Hae Chang: None declared, Jae-Bum Jun Grant/research support from: Clinical trials; Corbus, JW Pharmaceutical, Speakers bureau: SK Chemical, Yun Jong Lee: None declared, Tae Young Kang: None declared, Yongbeom Park: None declared, Seung-Geun Lee: None declared, Shin-Seok Lee: None declared, Eun Bong Lee: None declaredFigure 1

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Participants Attrition in a Longitudinal Study: The Malaysian Cohort Study Experience

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147216 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7216

Author(s):

Noraidatulakma Abdullah ◽

Mohd Arman Kamaruddin ◽

Ying-Xian Goh ◽

Raihannah Othman ◽

Andri Dauni ◽

...

Keyword(s):

Cohort Study ◽

Longitudinal Study ◽

Medical Treatment ◽

Drop Out ◽

Attrition Rate ◽

Kuala Lumpur ◽

Study Participation ◽

Study Objective ◽

Study Experience

The attrition rate of longitudinal study participation remains a challenge. To date, the Malaysian Cohort (TMC) study follow-up rate was only 42.7%. This study objective is to identify the cause of attrition among TMC participants and the measures to curb it. A total of 19,343 TMC participants from Kuala Lumpur and Selangor that was due for follow-up were studied. The two most common attrition reasons are undergoing medical treatment at another government or private health center (7.0%) and loss of interest in participating in the TMC project (5.1%). Those who were inclined to drop out were mostly Chinese, aged 50 years and above, unemployed, and had comorbidities during the baseline recruitment. We have also contacted 2183 participants for the home recruitment follow-up, and about 10.9% agreed to join. Home recruitment slightly improved the overall follow-up rate from 42.7% to 43.5% during the three-month study period.

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Stroke Recurrence in First-Ever Symptomatic Carotid Web: A Cohort Study

Journal of Stroke ◽

10.5853/jos.2020.05225 ◽

2021 ◽

Vol 23 (2) ◽

pp. 253-262

Author(s):

Stephane Olindo ◽

Nicolas Chausson ◽

Aissatou Signate ◽

Sylvie Mecharles ◽

Jean-Luc Hennequin ◽

...

Keyword(s):

Cohort Study ◽

Medical Treatment ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

High Rate ◽

Stroke Recurrence ◽

Symptomatic Carotid ◽

Cumulative Rate ◽

Cerebral Ischemic

Background and Purpose Carotid web (CaW) is an intimal variant of fibromuscular dysplasia responsible for ipsilateral cerebral ischemic events (CIE). Symptomatic CaW likely has a high risk of recurrent CIE, but no salient prospective data are available. We aimed to assess recurrence rate and its predictors after a first-ever CIE.Methods Consecutive Afro-Caribbean patients who had cryptogenic first-ever CIEs (ischemic stroke [IS] or transient ischemic attack [TIA]) associated with ipsilateral CaW were included in this multicenter observational cohort study. The follow-up (January 2008 to March 2019) focused on CIE recurrences. Kaplan-Meier method assessed rates of recurrences and Cox proportional hazards regression analyzed risk factors.Results Ninety-two patients (79 first-ever ISs and 13 TIAs; mean age±standard deviation, 49.8±9.9 years; 52 [56.5%] women) were included. During a mean follow-up of 50.5±29.6 months, 19 (20.7%) patients experienced recurrent ipsilateral CIEs (16 ISs and three TIAs). Of 23 patients receiving surgery/stenting treatment, no recurrence occurred after the intervention (median follow-up, 39.8 months [interquartile range, 27.6 to 72.4]). Under medical treatment alone, the annual recurrent CIE rate was 6.9%, and the cumulative rate was 4.4% at 30-day, 10.8% at 1-year, 19.8% at 2-year, 23.2% at 3-year, and 27.3% at 5-year. Presence of silent cerebral infarctions was the only independent risk factor of CIE recurrences (hazard ratio, 6.99; 95% confidence interval, 2.4 to 20.4; <i>P</i>=0.004).Conclusions Under medical treatment alone, symptomatic CaW was associated with a high rate of recurrence that reached 27.3% at 5-year. Surgery/stenting seems to be efficient, and randomized control trials are required to confirm the benefit of these interventions.

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Clinical presentation, management and follow-up of 83 patients with Leydig cell tumors of the testis: a prospective case-cohort study

Human Reproduction ◽

10.1093/humrep/dez083 ◽

2019 ◽

Vol 34 (8) ◽

pp. 1389-1403 ◽

Cited By ~ 8

Author(s):

Carlotta Pozza ◽

Riccardo Pofi ◽

Marta Tenuta ◽

Maria Grazia Tarsitano ◽

Emilia Sbardella ◽

...

Keyword(s):

Cohort Study ◽

Male Infertility ◽

Active Surveillance ◽

Leydig Cell ◽

Sperm Concentration ◽

Testicular Volume ◽

Total Testosterone ◽

Testicular Lesions ◽

Leydig Cell Tumors

Abstract STUDY QUESTION When should ‘not so rare’ Leydig cell tumors (LCTs) of the testis be suspected, diagnosed, and treated? SUMMARY ANSWER LCTs are more frequent than generally believed, are associated with male infertility, cryptorchidism and gynecomastia, and should be treated conservatively (in compliant patients) with active surveillance, which appears to be a safe alternative to surgical enucleation. WHAT IS KNOWN ALREADY Increasing referrals for testicular imaging have led to an increase in findings of LCTs. The features and natural history of these tumors remain largely unknown, as the available studies are small and heterogeneous. LCTs were previously treated aggressively and follow-up data are lacking. STUDY DESIGN, SIZE, DURATION A case-cohort study of consecutive patients diagnosed with LCTs over a 10-year period was prospectively enrolled from 2009 to 2018 and compared to matched cohorts of patients with seminomas or no testicular lesions screened in the same timeframe. PARTICIPANTS/MATERIALS, SETTING, METHODS Of the 9949 inpatients and outpatients referred for scrotal ultrasound, a total of 83 men with LCTs were included. Enrolled subjects underwent medical history and clinical examination and were asked to undergo routine blood tests, hormone investigations (FSH, LH, total testosterone, estradiol, inhibin B, sex hormone-binding globulin (SHBG), prolactin), and semen analysis. Patients who consented also underwent contrast-enhanced ultrasound, elastography, gadolinium-enhanced scrotal magnetic resonance imaging, and hCG stimulation test (5000 IU i.m.) with serum total testosterone and estradiol measured at 0, 24, 48, and 72 hours. MAIN RESULTS AND THE ROLE OF CHANCE In total, 83 patients diagnosed with LCTs were compared against 90 patients diagnosed with seminoma and 2683 patients without testicular lesions (NoL). LCTs were diagnosed by enucleation (48.2%), orchiectomy (13.3%), or clinical surveillance (38.5%). Testicular volume, sperm concentration, and morphology were lower (P = 0.001, P = 0.001, and P < 0.001, respectively) in patients with LCTs than in the NoL group. FSH, LH, and SHBG were higher and the testosterone/LH ratio was lower in LCTs than in the NoL group (P < 0.001). The LCT group showed higher SHBG (P = 0.018), lower sperm concentration (P = 0.029), and lower motility (P = 0.049) than the seminoma group. Risk factors for LCTs were cryptorchidism (χ2 = 28.27, P < 0.001), gynecomastia (χ2 = 54.22, P < 0.001), and low testicular volume (χ2 = 11.13, P = 0.001). Five cases were recurrences or bilateral lesions; none developed metastases during follow-up (median, 66 months). LIMITATIONS, REASONS FOR CAUTION This study has some limitations. First, hCG and second-line diagnostic investigations were not available for all tumor patients. Second, ours is a referral center for infertility, thus a selection bias may have altered the baseline features of the LCT population. However, given that the comparison cohorts were also from the same center and had been managed with a similar protocol, we do not expect a significant effect. WIDER IMPLICATIONS OF THE FINDINGS LCTs are strongly associated with male infertility, cryptorchidism, and gynecomastia, supporting the hypothesis that testicular dysgenesis syndrome plays a role in their development. Patients with LCTs are at a greater risk of endocrine and spermatogenesis abnormalities even when the tumor is resected, and thus require long-term follow-up and prompt efforts to preserve fertility after diagnosis. LCTs have a good oncological prognosis when recognized early, as tissue-sparing enucleation is curative and should replace orchiectomy. Conservative surgery and, in compliant patients, active surveillance through clinical and radiological follow-up are safe options, but require monitoring of testicular failure and recurrence. STUDY FUNDING/COMPETING INTEREST(S) The project was funded by the Ministry of University and Research Grant MIUR 2015ZTT5KB. There are no conflicts of interest. TRIAL REGISTRATION NUMBER ALCeP trial (ClinicalTrials.gov Identifier: NCT01206270).

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OUTCOMES OF FFR-GUIDED PCI IN INTERMEDIATE CORONARY ARTERY LESIONS

Journal of Medicine and Pharmacy ◽

10.34071/jmp.2018.3.12 ◽

2018 ◽

Vol 8 (3) ◽

pp. 77-81

Author(s):

Dang Duy Quang Nguyen ◽

Thi Thuy Phuong Cao ◽

Le Xuan Ngo ◽

Ngoc Son Nguyen ◽

Anh Binh Ho ◽

...

Keyword(s):

Cohort Study ◽

Comparative Analysis ◽

Coronary Artery ◽

Medical Treatment ◽

Key Words ◽

Coronary Artery Lesions ◽

Significant Difference ◽

Indication For Treatment

Background: Indication for treatment of intermediate coronary artery lesions is wavering. Worldwide studies showed the role of FFR in guiding the treatment for these cases. Objective: To study the outcomes of FFR-guided PCI in intermediate coronary artery lesions. Method: Cohort study with comparative analysis of 12-month MACE between two groups: Medical treatment with FFR > 0.8 and PCI with FFR ≤ 0.8. Results: 40 stenosis lesions with FFR ≤ 0.8 (57.14%) was treated by PCI and 30 stenosis lesions with FFR > 0.8 treated by medical therapy. The percentage stenotic diameter cut-off was >55.62% on QCA with Sp 60% and Se 75%. There was no significant difference in MACE between two groups after 12-month follow-up. Conclusions: FFR has important role in guiding treatment for intermediate coronary artery lesions. Key words: ffR-guided, coronary arery

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Endoscopic treatment of inverted papilloma attached in the frontal sinus/recess

Rhinology Journal ◽

10.4193/rhino14.177 ◽

2015 ◽

Vol 53 (4) ◽

pp. 317-324 ◽

Cited By ~ 1

Author(s):

G.F.J.P.M. Adriaensen ◽

M.W. van der Hout ◽

S.M. Reinartz ◽

C. Georgalas ◽

W.J. Fokkens

Keyword(s):

Frontal Sinus ◽

Attachment Site ◽

Complete Removal ◽

Postoperative Management ◽

Inverted Papilloma ◽

Postoperative Treatment ◽

Frontal Recess ◽

The Mean ◽

Disease Free

Background: Inverted papilloma (IP) is a benign sinonasal tumour for which endoscopic surgery, with complete removal of the underlying and surrounding mucoperiosteum at the attachment site followed by drilling and/or coagulation of this area, is the treatment of choice. This can be challenging in the frontal sinus. Objectives: To report on the outcome of treatment for IPs involving the frontal sinus. To propose the possible use of topical 5-fluorouracil 5% (5-FU) in the postoperative management of challenging IPs. Methods: This is a retrospective cohort evaluation of patients with IPs attached in the frontal sinus or in the frontal recess and growing into the frontal sinus. Data on primary or revision surgery, uni- or bilaterality, attachment site, surgical procedure, 5-FU usage, recurrence and follow-up are provided. The end points are disease-free follow-up in months and recurrence. Results: Twenty cases, including fifteen revision cases, were retrieved over a period of ten years. All cases were treated endoscopically. Two cases recurred (10%) and the intervention was repeated. In eight cases, 5-FU was applied at the end of surgery. None of these cases recurred. The mean follow-up after the last intervention was 42 months (standard deviation (SD) 22.1). Conclusion: IP involving the frontal sinus is a surgical challenge that can be successfully addressed endoscopically. The topical application of 5-FU could have a place in postoperative treatment when it is difficult to be absolutely sure that all diseased mucoperichondrium or mucoperiosteum at the attachment site(s) has been completely removed.

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Wait-and-See Policy for Clinical Complete Responders After Chemoradiation for Rectal Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2011.37.7176 ◽

2011 ◽

Vol 29 (35) ◽

pp. 4633-4640 ◽

Cited By ~ 580

Author(s):

Monique Maas ◽

Regina G.H. Beets-Tan ◽

Doenja M.J. Lambregts ◽

Guido Lammering ◽

Patty J. Nelemans ◽

...

Keyword(s):

Rectal Cancer ◽

Cohort Study ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Selection Criteria ◽

Complete Response ◽

Control Group ◽

Wait And See ◽

Strict Selection

Purpose Neoadjuvant chemoradiotherapy for rectal cancer can result in complete disappearance of tumor and involved nodes. In patients without residual tumor on imaging and endoscopy (clinical complete response [cCR]) a wait-and-see-policy (omission of surgery with follow-up) might be considered instead of surgery. The purpose of this prospective cohort study was to evaluate feasibility and safety of a wait-and-see policy with strict selection criteria and follow-up. Patients and Methods Patients with a cCR after chemoradiotherapy were prospectively selected for the wait-and-see policy with magnetic resonance imaging (MRI) and endoscopy plus biopsies. Follow-up was performed 3 to 6 monthly and consisted of MRI, endoscopy, and computed tomography scans. A control group of patients with a pathologic complete response (pCR) after surgery was identified from a prospective cohort study. Functional outcome was measured with the Memorial Sloan-Kettering Cancer Center (MSKCC) bowel function questionnaire and Wexner incontinence score. Long-term outcome was estimated by using Kaplan-Meier curves. Results Twenty-one patients with cCR were included in the wait-and-see policy group. Mean follow-up was 25 ± 19 months. One patient developed a local recurrence and had surgery as salvage treatment. The other 20 patients are alive without disease. The control group consisted of 20 patients with a pCR after surgery who had a mean follow-up of 35 ± 23 months. For these patients with a pCR, cumulative probabilities of 2-year disease-free survival and overall survival were 93% and 91%, respectively. Conclusion A wait-and-see policy with strict selection criteria, up-to-date imaging techniques, and follow-up is feasible and results in promising outcome at least as good as that of patients with a pCR after surgery. The proposed selection criteria and follow-up could form the basis for future randomized studies.

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