跳至主要内容
临床试验/NCT03496090
NCT03496090已完成不适用

Randomized Multicentric Controlled Clinical Trial of Parallel Groups to Evaluate the Non-therapeutic Inferiority of a Free Diet With a Progressive Diet, in the Treatment of Non-complicated Acute Diverticulitis

Hospital General Universitario Reina Sofía de Murcia2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2018年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
134
试验地点
2
主要终点
Success in the treatment

研究概览

简要总结

Phase III trial is designed to demonstrate the non-inferiority of a free diet versus a progressive diet in the treatment of acute diverticulitis (AD) without complications. In this study, the effectiveness of the short-term free diet is evaluated, as well as its safety and the quality of life that is perceived in front of the progressive diet.

详细描述

The study will be carried out in the General Surgery and Gastroenterology Services of the following centers:

  • Hospital General Universitario Reina Sofía
  • Hospital General Universitario Morales Meseguer de Murcia.
  • Hospital Universitario Santa Lucía de Cartagena.
  • Hospital General Universitario de Elche.
  • Complejo Hospitalario Torrecárdenas de Almería

All patients with increased temperature and acute abdominal pain, as well as clinical suspicion of AD, will be screened for their potential selection in the study. Basic blood tests (hemogram) and abdominal ultrasound will be performed and these guidelines will be followed: if the results indicate complicated AD, it will be excluded from the study; if uncomplicated DA is suspected, blood CRP will be requested; if CRP is less than 5 mg / dl, it will be included in the study and ambulatory treatment will be indicated; if CRP is greater than 5mg / dl, abdominal CT with intravenous contrast will be requested. Result: uncomplicated DA, it will be included in the study and it will be indicated ambulatory treatment or complicated DA, it will be excluded from the study-; those patients with uncomplicated AD, but with risk factors, hospital admission will be recommended, and they may be offered to participate in the study.

If the patient meets the criteria for admission to the study, the attending physician (surgeon on duty) will inform and invite them to participate and after signing the informed consent, their data will be collected and they will be contacted. the person of the hospital, in charge of guarding the list and randomization codes to assign him the corresponding research group: group 1 (free diet) or group 2 (progressive diet) (Annex III), - this group will be delivered of your printed diet and you will be instructed about it, as well as, to all patients, the annotations of pain control and temperature on ad-hoc sheet. The patient data will be delivered to the investigator / s of the study of each hospital, who will fill in the Data Collection Notebook (DCN) of each patient and program their controls without information of the group to which the patient has been assigned, as In this way, the consultations are carried out with blinding of the evaluator (the investigator who will do the controls will not know to which group the patient has been assigned). They will also be asked a quality of life questionnaire SF-12 (baseline) and they will be asked for a blood test with a complete blood count and CRP for the 3rd day of treatment.

Outpatients will be contacted daily by phone during the first 3 days of treatment by the study investigator and between the 3rd and 4th day will go to outpatient surgery for clinical and analytical control (1st consultation), filling in the DCN. The hospitalized patients will follow the same clinical and analytical control by the plant surgeon and the study investigator, filling in the DCN. They will be asked for new blood tests with CRP for the 7th day of treatment and, in those patients who do not have a colonoscopy in the last 12 months prior to entering the study, an endoscopic study will be requested before 60 days for confirmation of diverticular disease, filling in the DCN. They will be given a new SF-12 quality of life questionnaire that they will fill out on the 7th day of the start of the treatment. They will be cited for a new consultation (2nd consultation) to all patients (outpatients and those who have been hospitalized), 30 days of the beginning of the treatment, with new clinical control and annotation of the last analytical, as well as third and last SF-12 quality of life questionnaire, in the DCN. To conclude, patients who were asked for colonoscopy, will be cited in a final consultation (3rd) 2 months after beginning the treatment with the endoscopic result closing the study, with the last entries in the DCN.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The patient data will be delivered to the investigator/s of the study of each hospital, who will fill out the Data Collection Notebook (DCN) of each patient and program their controls without information of the group to which the patient has been assigned, as such In this way, the consultations are carried out with blinding of the evaluator (the investigator who will do the controls will not know to which group the patient has been assigned).

The person in charge of carrying out the statistical analysis will not be able to know to which group the patient has been assigned due to the coding done in the DCN.

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

  • Diagnosis of uncomplicated acute diverticulitis
  • Adequate oral tolerance
  • Good response to the first emergency treatment measures (analgesics and antibiotic therapy): improvement of pain and decrease in temperature.
  • Willing to continue treatment at home under supervision.
  • Accept sign informed consent.

排除标准

  • Acute complicated diverticulitis (from grade Ib of the modified Hinchey Classification).
  • No good response to the first emergency treatment measures (analgesics and antibiotics): maintenance or increase of abdominal pain, persistence of fever, oral intolerance or vomiting, clinical worsening.
  • Antibiotic treatment for diverticulitis in the previous month.
  • Suspicion of colorectal cancer.
  • Pregnant.
  • Refuses to sign informed consent.

研究组 & 干预措施

Free diet

Experimental

Free diet or free demand, being comparable to the normal or zero hospital diet

干预措施: Free diet (Other)

Progressive diet

Active Comparator

Progressive diet for 7 days, liquid diet for the first three days and soft diet without waste, from the 4th to the 7th day.

干预措施: Progressive diet (Other)

结局指标

主要结局

Success in the treatment

时间窗: 30 days

Absence of persistence, increase or recurrence of abdominal pain or fever, transition to a stage higher than that of the modified Hinchey classification (requiring radiological drainage and / or surgical treatment), need for hospital admission (for outpatients) and death attributed to this diagnosis.

次要结局

  • Pain score(7 days)
  • PCR value(day 0, 3 and 7)
  • Body temperature(7 days)
  • Increase in stage(30 days)
  • Need for hospital admission(30 days)

研究者

发起方
Hospital General Universitario Reina Sofía de Murcia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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