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临床试验/NCT03959020
NCT03959020已完成不适用

Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
520
试验地点
1
主要终点
Treatment failure

研究概览

简要总结

Introduction Laparoscopic anti-reflux surgery is considered standard of care in surgical treatment of gastro-oesophageal reflux disease and is not without risks of adverse effects, most notably disruption of the fundoplication, post-fundoplication dysphagia and gas-bloat-syndrome, in some cases leading to reoperation. Non-surgical factors such as pre-existing anxiety or depression disorders can influence postoperative satisfaction and symptom relief. Previous studies have focused on short-term follow-up or only certain aspects of disease, resulting in a less than complete picture.

The aim of this study is to evaluate long-term patient-satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort using comprehensive multimodal follow-up, and using the results of follow-up, to develop a clinically applicable scoring system usable in selecting patients for anti-reflux surgery.

Methods and analysis The study is a retrospective cohort study utilizing data from patient records and follow-up with patient-reported quality of life as well as registry-based data. The study population consists of all adult patients having undergone laparoscopic anti-reflux surgery at The Department of Surgery, Kolding Hospital, a part of Lillebaelt Hospital Denmark in an 11-year period. From electronic records; patient characteristics, preoperative endoscopic findings, reflux disease characteristics and details on type of surgery, will be identified. Disease specific quality-of-life and dysphagia will be identified from patient-reported follow-up. From Danish national registries, data on comorbidity, reoperative surgery, use of pharmacological anti-reflux treatment, mortality and socioeconomic factors will be included. Primary outcome of this study is treatment success at follow-up.

Ethics and dissemination For the study approval will be sought from The Danish Patient Safety Agency, The Danish Health Data Authority and Statistics Denmark, complying to Danish and EU current legislation. Inclusion in the study will require informed consent from participating subjects.

详细描述

Aim To use registry-based data and long-term quality of life follow up after anti-reflux surgery to quantify efficacy of treatment and to propose a clinically applicable tool to improve patient selection for surgery.

Background Treatment of GERD consists of anti-secretory drugs, mainly proton pump inhibitors, or anti-reflux surgery. Laparoscopic anti-reflux surgery is considered standard of care in surgical treatment of gastro-esophageal reflux disease and with careful patient selection based on thorough preoperative workup; symptom control and patient satisfaction are high compared to medical therapy).

Despite a tailored approach, laparoscopic anti-reflux surgery is not without risks of adverse effects, most notably disruption of the fundoplication, post-fundoplication dysphagia and gas-bloat-syndrome, in some cases leading to reoperation. Furthermore non-surgical factors such as pre-existing anxiety or depression disorders can influence postoperative satisfaction and symptom relief when compared to patients without concomitant psychological disorders.

Although few studies conclude that medical and surgical treatment of GERD have similar effectiveness, disease-specific quality of life generally improves after anti-reflux surgery and patient satisfaction is high. Depending on surgical procedure, the postoperative quality of life, ranges from significantly increased compared to preoperative measurements, to "normal" values as found in subjects devoid of GERD. 73-98% are satisfied with their condition after surgery and would choose surgery again.

Follow-up of randomized clinical trials have demonstrated, that anti-reflux surgery patients use acid suppressing drugs, primarily proton pump inhibitor (PPI) therapy at postoperative follow-up. Use have been considered minimal with <20% using PPI-therapy and 27-44% using PPI at five-year follow-up. A recent register-based study, demonstrated a greater number of redeemed prescriptions of proton pump inhibitor after primary anti-reflux surgery, than previously known. Five-, 10- and 15-year risks of long-term PPI use were 29.4%, 41.1% and 56.6%. However, this register-based study could not examine whether patients had objective recurrence of reflux disease and also did not examine indication for treatment as well as prescribing physician. From 2001 to 2011, 94,4% of PPI where prescribed in primary care and it is unknown why post-fundoplication patients are prescribed PPI. It has previously been demonstrated, that the use of acid suppressing drugs after anti-reflux surgery does not necessarily correlate with abnormal acid exposure to the esophagus . In general, the use of PPI has increased rapidly in Denmark, rising 243% from 2001 to 2011 despite more restrictive guidelines and changes in reimbursement . It must also be taken under consideration that although PPIs are a safe group of drugs, there are possible side effects such as increased risk of fractures, interaction with platelet inhibitor Clopidogrel, increased risk of kidney failure, pneumonia and hypomagnesaemia. As the majority of proton pump inhibitors are prescribed by general practitioners and not by the surgical centers, surgeons have very little knowledge of this aspect of life following anti-reflux surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having undergone any anti-reflux surgery at Department of Surgery, Kolding Hospital, a part of Hospital Lillebaelt, Denmark from January 1, 2002 to December 31, 2013

排除标准

  • 未提供

结局指标

主要结局

Treatment failure

时间窗: From surgery to 1th January 2019 (Up to 17 years)

Failure of anti-reflux surgery defined as 1. Having undergone reoperation (NSCP: KJBC00-02, KJBW96-98, KJBB00-01, KJBB96-97) between index date and end of follow-up. 2. Having filled prescription of \>60 DDD/year of PPI in any year between index date and end of follow-up. 3. Having no measure \>3 on GERD-HRQL indicating symptoms being bothersome every day. 4. Having no measure \>4 on Dysphagia Handicap index indicating symptoms being a moderate problem.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonas Sanberg Jensen

Ph.d.-student

University of Southern Denmark

研究点 (1)

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