An interventional study of Free diet and Progressive diet in Diverticulitis, Acute Diverticulitis and Diverticulitis, Colonic, sponsored by Hospital General Universitario Reina Sofía de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Hospital General Universitario Reina Sofía de Murcia · Not applicable, Interventional, and Treatment
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.
The study will be carried out in the General Surgery and Gastroenterology Services of the following centers:
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.
Sample size:
To obtain a power of 80% to reject the null hypothesis Ho: that the difference of proportions p1 and p2 is lower than the non-inferiority limit of -10, and taking into account that the level of significance is 5%, assuming that the proportion of non-treatment failure in both treatment groups is 94.7%, the total number of patients expected to be included in the study is 134 patients, with an expected percentage of dropouts of 5%, which 67 patients will receive treatment through free diet and other 67 patients through progressive diet. The endpoint for the main comparison is the proportion of subjects with a lower treatment failure rate at one month (30 days) of follow-up.
Statistical treatment:
The continuous variables will be summarized using descriptive statistics: mean, standard deviation (SD), median, minimum, maximum, number of observations and number of missing observations. Non-normal continuous data will be presented as maximum, top quartile, median, lowest quartile, minimum and number of observations. The categorical variables will be described using absolute and relative frequencies.
For the comparisons between variables, the bivariate analysis will be used. The scores of each dependent variable will be compared with the independent variables using parametric statistical methods (and nonparametric when the parametric application criteria are not met). When the changes within the same treatment group are analyzed, statistical tests for related or paired samples will be used.
In the event that the variables follow the normal distribution, one or more of the following techniques will be described:
In the case that the variables do not follow the normal distribution:
For the non-inferiority analysis in the main variables, a calculation will be made using the Farrington-Manning score, Miettinen-Nurminen Score and Gart-Nam Score tests, with a significance level of 0.05, and a limit of no- inferiority of 0.10. For the continuous variables, non-inferiority will be evaluated by the difference of means with the Mann-Whitney U and the Wilcoxon test.
All statistical comparisons will be made using statistical tests with a level of significance p = 0.05.
27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.
This study's enrollment of 134 is close to the median of 142 across 10 interventional studies indexed under Diverticulitis, Colonic.
Browse Diverticulitis, Colonic studies →Hospital General Universitario Reina Sofía de Murcia is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Diverticulitis, Colonic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diverticulitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Free diet or free demand, being comparable to the normal or zero hospital diet
Other: Free diet
Progressive diet for 7 days, liquid diet for the first three days and soft diet without waste, from the 4th to the 7th day.
Other: Progressive diet
Free diet or free demand, being comparable to the normal or zero hospital diet
Also known as: Basal diet
Progressive diet for 7 days, liquid diet for the first three days and soft diet without waste, from the 4th to the 7th day.
Success in the treatment
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.
Time frame: 30 days
Pain score
The evaluation in each treatment group of pain intensity, using visual analogue scale (VAS) of pain, self-evaluated daily after dinner. Min value 0. Max value 10. Higher values represent a worse outcome.
Time frame: 7 days
Body temperature
Axillary temperature curve, as a reference, by one shot every 12 hours.
Time frame: 7 days
PCR value
The comparison in each treatment group of the levels of C-reactive protein (CRP).
Time frame: day 0, 3 and 7
Increase in stage
Percentage of patients in each treatment group who pass to a stage higher than Ia in the Hinchey classification modified.
Time frame: 30 days
Need for hospital admission
Percentage of outpatients in each treatment group who require hospital admission.
Time frame: 30 days
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Reina Sofía de Murcia