T1562 Health Related Quality of Life After Minimally Invasive Surgery for Diverticular Disease

Abstract Background Women tend to delay dental treatment due to misconceptions regarding the safety of dental procedures during pregnancy which may negatively affect their quality of life. Minimally invasive restorative techniques offer alternatives for caries treatment and can improve their oral health-related quality of life (OHRQoL) during this stage. Methods A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting public family health centers in Alexandria, Egypt, with mild to moderate dental pain due to caries. Participants were randomly assigned into Papacarie-Duo group (n = 82) and ART group (n = 80). The outcome variable was percent change in OHRQoL (oral health impact profile, OHIP-14) after 6 months. T test/Mann Whitney U test were used to compare groups and a multivariable linear regression analysis was conducted to evaluate the factors affecting the outcome variable. Results A significant reduction (P < 0.002) was noted in OHIP-14 between baseline and 6 months indicating improvement in OHRQoL in the Papacarie-Duo and ART groups (16.26% and 18.91%, P = 0.120 in bivariate analysis). Multiple linear regression revealed significantly greater reduction in OHIP-14 scores in the Papacarie-Duo than the ART group (regression coefficient = 4.03, 95% confidence interval: 0.652, 7.409, P = 0.020). Conclusion Minimally invasive restorative techniques, such as ART and chemo-mechanical caries removal using Papacarie- Duo can improve the OHRQoL of pregnant women suffering from mild to moderate pain due to dental caries. Significantly more improvement was noted in the Papacarie-Duo group after adjusting all other variables. Trial registration ID NCT04619264 (https://clinicaltrials.gov/); November 6 2020, retrospective registration. (https://clinicaltrials.gov/ct2/show/NCT04619264?term=NCT04619264&draw=2&rank=1)

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PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study

BMJ Open ◽

10.1136/bmjopen-2019-034385 ◽

2020 ◽

Vol 10 (3) ◽

pp. e034385

Author(s):

Maximilian Sohn ◽

Ayman Agha ◽

Igors Iesalnieks ◽

Susanne Bremer ◽

Stefanie Trum ◽

...

Keyword(s):

Quality Of Life ◽

Observational Study ◽

Diverticular Disease ◽

Resected Specimen ◽

Medical Council ◽

Health Related Quality ◽

Custom Made ◽

Related Quality ◽

Health Related

IntroductionDiverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a change in HrQoL in patients after elective sigmoidectomy for diverticular disease.Methods and analysisA prospective multicentre transnational observational study was started in November 2017. Patients undergoing elective sigmoid resection for diverticular disease were included. Primary outcome includes HrQoL 6 months postoperatively, staged by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes include HrQoL 6 months after sigmoidectomy, assessed using the Short Form 36 Questionnaire and a custom-made Visual Analogue Scale-based inventory; HrQoL after 12 and 24 months; postoperative morbidity; mortality; influence of surgical technique (conventional laparoscopic multiport operation vs robotic approach); histological grading of inflammation and morphological characteristics of the bowel wall in the resected specimen; postoperative functional changes (faecal incontinence, faecal urge, completeness of emptying, urinary incontinence, sexual function); disease-specific healthcare costs; and changes in economic productivity, measured by the iMTA Productivity Cost Questionnaire. The total follow-up will be 2 years.Ethics and disseminationThe protocol was approved by the medical ethical committee of the Bavarian Medical Council (report identification number: 2017-177). The study was conducted in accordance with the Declaration of Helsinki. The findings of this study will be submitted to a peer-reviewed journal (BMJ Open,Annals of Surgery,British Journal of Surgery,Diseases of the Colon and the Rectum). Abstracts will be submitted to relevant national and international conferences.Trial registration numberThe study is registered with the ClinicalTrials.gov register asNCT03527706; Pre-results.

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