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Randomized Multicentric Trial to Evaluate a Free Diet With a Progressive Diet in the Treatment of Acute Diverticulitis (DIVERDIET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496090
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital General Universitario Reina Sofía de Murcia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diverticulitis Acute Diverticulitis Diverticulitis, Colonic Uncomplicated Diverticular Disease Diverticulitis of Sigmoid Diet Modification Dietary Modification Other: Free diet Other: Progressive diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a randomized, multicentric, controlled with active comparator, parallel group, blind to the evaluator, to demonstrate the non-inferiority in the efficacy and therapeutic and safety of the free diet (group 1) compared to the progressive diet (group 2) in the treatment of uncomplicated acute diverticulitis. This study will be carried out on 134 patients with uncomlpicated acute diverticulitis. The subjects will be randomized in a 1: 1 ratio to receive treatment with progressive diet or diet at free demand. The main analysis will take place two months after the start of treatment.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : April 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Free diet
Free diet or free demand, being comparable to the normal or zero hospital diet
Other: Free diet
Free diet or free demand, being comparable to the normal or zero hospital diet
Other Name: Basal diet

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




Primary Outcome Measures :
  1. Success in the treatment [ Time Frame: 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.


Secondary Outcome Measures :
  1. Pain score [ Time Frame: 7 days ]
    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.

  2. Body temperature [ Time Frame: 7 days ]
    Axillary temperature curve, as a reference, by one shot every 12 hours.

  3. PCR value [ Time Frame: day 0, 3 and 7 ]
    The comparison in each treatment group of the levels of C-reactive protein (CRP).

  4. Increase in stage [ Time Frame: 30 days ]
    Percentage of patients in each treatment group who pass to a stage higher than Ia in the Hinchey classification modified.

  5. Need for hospital admission [ Time Frame: 30 days ]
    Percentage of outpatients in each treatment group who require hospital admission.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496090


Locations
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Spain
Hospital General Universitario Reina Sofía
Murcia, Spain, 30003
Sponsors and Collaborators
Hospital General Universitario Reina Sofía de Murcia
Investigators
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Principal Investigator: Jorge A Benavides Buleje, Dr. Hospital General Universitario Reina Sofía de Murcia
Additional Information:
Publications of Results:
Sartelli M, Catena F, Ansaloni L, Coccolini F, Griffiths EA, Abu-Zidan FM, Di Saverio S, Ulrych J, Kluger Y, Ben-Ishay O, Moore FA, Ivatury RR, Coimbra R, Peitzman AB, Leppaniemi A, Fraga GP, Maier RV, Chiara O, Kashuk J, Sakakushev B, Weber DG, Latifi R, Biffl W, Bala M, Karamarkovic A, Inaba K, Ordonez CA, Hecker A, Augustin G, Demetrashvili Z, Melo RB, Marwah S, Zachariah SK, Shelat VG, McFarlane M, Rems M, Gomes CA, Faro MP, Júnior GA, Negoi I, Cui Y, Sato N, Vereczkei A, Bellanova G, Birindelli A, Di Carlo I, Kok KY, Gachabayov M, Gkiokas G, Bouliaris K, Çolak E, Isik A, Rios-Cruz D, Soto R, Moore EE. WSES Guidelines for the management of acute left sided colonic diverticulitis in the emergency setting. World J Emerg Surg. 2016 Jul 29;11:37. doi: 10.1186/s13017-016-0095-0. eCollection 2016. Review.

Other Publications:
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Responsible Party: Hospital General Universitario Reina Sofía de Murcia
ClinicalTrials.gov Identifier: NCT03496090    
Other Study ID Numbers: DIVERDIET
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital General Universitario Reina Sofía de Murcia:
Diverticulitis
Uncomplicated Diverticular Disease
Free diet
Dietary restriction
Acute Diverticulitis
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Diverticulum
Diverticulitis, Colonic
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases