Acute DiverticulitisPhase 4NCT02785549
Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics
A Phase 4 study testing Ibuprofen, Acetaminophen and Amoxicillin/clavulanic acid in people with Acute Diverticulitis, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Ibuprofen, Acetaminophen and Amoxicillin/clavulanic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to 1 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's written informed consent. Adequate cognitive capacity.
- Adequate family support
- No acute diverticulitis episode in the last 3 months
- mNeff 0 acute diverticulitis (abdominal computed tomography scan)
- No antibiotic treatment in the last 2 weeks
- Immunocompetence*
Show all 10Show fewer
- No significant comorbidities**
- Good oral tolerance
- Good symptom control
- Maximum one of the following SIRS criteria (* T>38 ºC or <36ºC, L>12,000 or <4000/uL, HR>90 bpm, RR<20 rpm) or CRP>15 mg/dL
Who cannot join
- Women in pregnancy or breastfeeding
- Age <18 years or > 80 years.
- Absence of the patient's written informed consent. Inadequate cognitive capacity.
- Inadequate family support
- Acute diverticulitis episode in the last 3 months
- Moderate acute diverticulitis (mNeff grade I or upper)
Show all 15Show fewer
- Antibiotic treatment in the last 2 weeks
- Inflammatory bowel disease
- Immunodepression*
- Presence of significant comorbidities**
- Bad oral tolerance
- Poor symptom control
- More than one of the following SIRS criteria (* T>38 ºC or <36ºC, L>12,000 or <4000/uL, HR>90 bpm, RR<20 rpm) or CRP>15 mg/dL
- () Immunocompetence is the absence and immunodepression is the presence of any of the following: active neoplastic disease/hematologic malignancy/HIV with low CD4+ count/long-term corticosteroid treatment/immunosuppressant therapy/transplant/splenectomy/genetic immunodeficiency.
- () We consider significant comorbidities any of the following: poorly controlled diabetes mellitus (HbA1>7mg/dl), cardiologic event in the last 3 months, decompensation of hepatopathy in the last 3 months, renal chronic insufficiency in dialysis programme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics
Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.
Read the detailed description
In the last years, traditional pathologic mechanisms of acute diverticulitis are being questioned and replaced by more scientifically grounded hypotheses that strongly postulate an inflammatory origin. Local pro-inflammatory cytokines, microbiota shifts, disturbed neurological intestinal signalling due to alterations in colonic neuropeptides and abnormal colonic motility are all being proposed as potential etiologic factors. Recent publications, therefore, call into question the benefits of antibiotic treatment or episodes of acute diverticulitis, especially for mild episodes. Furthermore, recent international guidelines endorse this stance in their recommendations. Moreover, recent studies provide evidence regarding the security of treating patients with mild acute diverticulitis as outpatients.
The investigators think that outpatient treatment without antibiotic for mild acute diverticulitis is not-inferior to traditional treatment with antibiotic, measuring the efficacy with readmission ratio. For this reason we have designed a multicentric, randomised, prospective study.
All patients seen in the emergency department with clinical signs of acute diverticulitis (left iliac fossa abdominal pain, peritoneal irritation signs and/or leucocytosis) will undergo an abdominal computed tomography to confirm the diagnosis and grade the disease according to severity using the modified Neff (mNeff) classification. Those with mild acute diverticulitis (grade 0), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.
Primary goal is to determine if, in mild acute diverticulitis, the treatment without antibiotic is not-inferior to the traditional treatment with antibiotic considering readmission ratio.
Secondary goals include the analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation, reason for readmission (bad symptoms control, radiologic progression, analysis worsening), pain control (analogic visual scale), recuperation after the acute episode, complication rate and their treatment.
- Conditions
- Acute Diverticulitis
- Being tested
- Ibuprofen, Acetaminophen, Amoxicillin/clavulanic acid
- Keywords
- Acute diverticulitis, Antibiotic, Outpatient treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
600 mg/8hours
AcetaminophenDrug
Also called Paracetamol
1 g/8 hours
Amoxicillin/clavulanic acidDrug
875mg/125mg/8 hours
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic treatment with NSAID | Experimental | 1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen Receives: Drug: Ibuprofen; Drug: Acetaminophen |
| Antibiotic+symptomatic treatment with NSAID | Active comparator | 875/125mg /8h amoxicillin/clavulanic acid and symptomatic treatment with 1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen Receives: Drug: Ibuprofen; Drug: Acetaminophen; Drug: Amoxicillin/clavulanic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission ratio
Primary outcome is to determine if, in mild acute diverticulitis, the treatment without antibiotic is not-inferior to the traditional treatment with antibiotic considering readmission ratio.
Measured: 3 months
Secondary outcomes (5)
Reconsultation ratio
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
Measured: 3 months
Reason for reconsultation
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
Measured: 3 months
Reason for readmission
The analysis of the differences between groups, in case there are, in relation to reason for readmission (bad symptoms control, radiologic progression, analysis worsening)
Measured: 3 months
Pain control
The analysis of the differences between groups, in case there are, in relation to pain control (analogic visual scale), during follow-up.
Measured: 48 hours, 7 days, 1 month, 3 months
Complications
Description of the complications in both groups (perforation, abscess) and its treatment (percutaneous drainage, emergency surgery, broad spectrum antibiotics)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startNov 2016
- Primary completion12 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neus Ruiz-Edo, Corporacion Parc Tauli
- Investigators
- Neus Ruiz, MD, Principal investigator, Corporacion Parc TauliLaura Mora, MD PhD, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785549
- Sponsor's protocol ID
- CIR-DISA-2016
- Other IDs
- 2016-001596-75, 2016
- Status last verified
- May 2020
- First submitted
- 25 May 2016
- Last updated
- 14 May 2020
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Strate LL, Modi R, Cohen E, Spiegel BM. Diverticular disease as a chronic illness: evolving epidemiologic and clinical insights. Am J Gastroenterol. 2012 Oct;107(10):1486-93. doi: 10.1038/ajg.2012.194. Epub 2012 Jul 10.
PubMed 22777341Daniels L, Budding AE, de Korte N, Eck A, Bogaards JA, Stockmann HB, Consten EC, Savelkoul PH, Boermeester MA. Fecal microbiome analysis as a diagnostic test for diverticulitis. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):1927-36. doi: 10.1007/s10096-014-2162-3. Epub 2014 Jun 4.
PubMed 24894339Espin F, Rofes L, Ortega O, Clave P, Gallego D. Nitrergic neuro-muscular transmission is up-regulated in patients with diverticulosis. Neurogastroenterol Motil. 2014 Oct;26(10):1458-68. doi: 10.1111/nmo.12407. Epub 2014 Aug 11.
PubMed 25109425Humes DJ, Simpson J, Smith J, Sutton P, Zaitoun A, Bush D, Bennett A, Scholefield JH, Spiller RC. Visceral hypersensitivity in symptomatic diverticular disease and the role of neuropeptides and low grade inflammation. Neurogastroenterol Motil. 2012 Apr;24(4):318-e163. doi: 10.1111/j.1365-2982.2011.01863.x. Epub 2012 Jan 25.
PubMed 22276853Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.
PubMed 22290281Isacson D, Thorisson A, Andreasson K, Nikberg M, Smedh K, Chabok A. Erratum to: Outpatient, non-antibiotic management in acute uncomplicated diverticulitis: a prospective study. Int J Colorectal Dis. 2015 Sep;30(9):1235. doi: 10.1007/s00384-015-2284-9. No abstract available.
PubMed 26084881Estrada Ferrer O, Ruiz Edo N, Hidalgo Grau LA, Abadal Prades M, Del Bas Rubia M, Garcia Torralbo EM, Heredia Budo A, Sunol Sala X. Selective non-antibiotic treatment in sigmoid diverticulitis: is it time to change the traditional approach? Tech Coloproctol. 2016 May;20(5):309-315. doi: 10.1007/s10151-016-1464-0. Epub 2016 Apr 6.
PubMed 27053254Brochmann ND, Schultz JK, Jakobsen GS, Oresland T. Management of acute uncomplicated diverticulitis without antibiotics: a single-centre cohort study. Colorectal Dis. 2016 Nov;18(11):1101-1107. doi: 10.1111/codi.13355.
PubMed 27089051Unlu C, de Korte N, Daniels L, Consten EC, Cuesta MA, Gerhards MF, van Geloven AA, van der Zaag ES, van der Hoeven JA, Klicks R, Cense HA, Roumen RM, Eijsbouts QA, Lange JF, Fockens P, de Borgie CA, Bemelman WA, Reitsma JB, Stockmann HB, Vrouenraets BC, Boermeester MA; Dutch Diverticular Disease 3D Collaborative Study Group. A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial). BMC Surg. 2010 Jul 20;10:23. doi: 10.1186/1471-2482-10-23.
PubMed 20646266Andersen JC, Bundgaard L, Elbrond H, Laurberg S, Walker LR, Stovring J; Danish Surgical Society. Danish national guidelines for treatment of diverticular disease. Dan Med J. 2012 May;59(5):C4453.
PubMed 22549495Andeweg CS, Mulder IM, Felt-Bersma RJ, Verbon A, van der Wilt GJ, van Goor H, Lange JF, Stoker J, Boermeester MA, Bleichrodt RP; Netherlands Society of Surgery; Working group from Netherlands Societies of Internal Medicine, Gastroenterologists, Radiology, Health echnology Assessment and Dieticians. Guidelines of diagnostics and treatment of acute left-sided colonic diverticulitis. Dig Surg. 2013;30(4-6):278-92. doi: 10.1159/000354035. Epub 2013 Aug 20.
PubMed 23969324Cuomo R, Barbara G, Pace F, Annese V, Bassotti G, Binda GA, Casetti T, Colecchia A, Festi D, Fiocca R, Laghi A, Maconi G, Nascimbeni R, Scarpignato C, Villanacci V, Annibale B. Italian consensus conference for colonic diverticulosis and diverticular disease. United European Gastroenterol J. 2014 Oct;2(5):413-42. doi: 10.1177/2050640614547068.
PubMed 25360320Kruis W, Germer CT, Leifeld L; German Society for Gastroenterology, Digestive and Metabolic Diseases and The German Society for General and Visceral Surgery. Diverticular disease: guidelines of the german society for gastroenterology, digestive and metabolic diseases and the german society for general and visceral surgery. Digestion. 2014;90(3):190-207. doi: 10.1159/000367625. Epub 2014 Nov 19.
PubMed 25413249Mora Lopez L, Serra Pla S, Serra-Aracil X, Ballesteros E, Navarro S. Application of a modified Neff classification to patients with uncomplicated diverticulitis. Colorectal Dis. 2013 Nov;15(11):1442-7. doi: 10.1111/codi.12449.
PubMed 24192258Alonso S, Pera M, Pares D, Pascual M, Gil MJ, Courtier R, Grande L. Outpatient treatment of patients with uncomplicated acute diverticulitis. Colorectal Dis. 2010 Oct;12(10 Online):e278-82. doi: 10.1111/j.1463-1318.2009.02122.x.
PubMed 19906059
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics
- ClinicalTrials.gov ID
- NCT02785549
- Acronym / sponsor ID
- CIR-DISA-2016
- Conditions
- Acute Diverticulitis
- Keywords
- Acute diverticulitis, Antibiotic, Outpatient treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 12 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.
Detailed description
In the last years, traditional pathologic mechanisms of acute diverticulitis are being questioned and replaced by more scientifically grounded hypotheses that strongly postulate an inflammatory origin. Local pro-inflammatory cytokines, microbiota shifts, disturbed neurological intestinal signalling due to alterations in colonic neuropeptides and abnormal colonic motility are all being proposed as potential etiologic factors. Recent publications, therefore, call into question the benefits of antibiotic treatment or episodes of acute diverticulitis, especially for mild episodes. Furthermore, recent international guidelines endorse this stance in their recommendations. Moreover, recent studies provide evidence regarding the security of treating patients with mild acute diverticulitis as outpatients.
The investigators think that outpatient treatment without antibiotic for mild acute diverticulitis is not-inferior to traditional treatment with antibiotic, measuring the efficacy with readmission ratio. For this reason we have designed a multicentric, randomised, prospective study.
All patients seen in the emergency department with clinical signs of acute diverticulitis (left iliac fossa abdominal pain, peritoneal irritation signs and/or leucocytosis) will undergo an abdominal computed tomography to confirm the diagnosis and grade the disease according to severity using the modified Neff (mNeff) classification. Those with mild acute diverticulitis (grade 0), following the inclusion criteria and giving informed consent, will be included in the study protocol and will be randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the episode.
Primary goal is to determine if, in mild acute diverticulitis, the treatment without antibiotic is not-inferior to the traditional treatment with antibiotic considering readmission ratio.
Secondary goals include the analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation, reason for readmission (bad symptoms control, radiologic progression, analysis worsening), pain control (analogic visual scale), recuperation after the acute episode, complication rate and their treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic treatment with NSAID | Experimental | Drug: Ibuprofen, Drug: Acetaminophen1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen |
| Antibiotic+symptomatic treatment with NSAID | Active comparator | Drug: Ibuprofen, Drug: Acetaminophen, Drug: Amoxicillin/clavulanic acid875/125mg /8h amoxicillin/clavulanic acid and symptomatic treatment with 1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient's written informed consent. Adequate cognitive capacity.
- Adequate family support
- No acute diverticulitis episode in the last 3 months
- mNeff 0 acute diverticulitis (abdominal computed tomography scan)
- No antibiotic treatment in the last 2 weeks
Key exclusion criteria (15 listed)
- Women in pregnancy or breastfeeding
- Age <18 years or > 80 years.
- Absence of the patient's written informed consent. Inadequate cognitive capacity.
- Inadequate family support
- Acute diverticulitis episode in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen600 mg/8hours | Drug | Antibiotic+symptomatic treatment with NSAID, Symptomatic treatment with NSAID |
| AcetaminophenAlso: Paracetamol1 g/8 hours | Drug | Antibiotic+symptomatic treatment with NSAID, Symptomatic treatment with NSAID |
| Amoxicillin/clavulanic acid875mg/125mg/8 hours | Drug | Antibiotic+symptomatic treatment with NSAID |
Primary outcome
Readmission ratio
Time frame: 3 months
Primary outcome is to determine if, in mild acute diverticulitis, the treatment without antibiotic is not-inferior to the traditional treatment with antibiotic considering readmission ratio.
5 secondary outcomes
Reconsultation ratio
Time frame: 3 months
Reason for reconsultation
Time frame: 3 months
Reason for readmission
Time frame: 3 months
Pain control
Time frame: 48 hours, 7 days, 1 month, 3 months
Complications
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Background: PubMed 22777341Strate LL, Modi R, Cohen E, Spiegel BM. Diverticular disease as a chronic illness: evolving epidemiologic and clinical insights. Am J Gastroenterol. 2012 Oct;107(10):1486-93. doi: 10.1038/ajg.2012.194. Epub 2012 Jul 10.
- Background: PubMed 24894339Daniels L, Budding AE, de Korte N, Eck A, Bogaards JA, Stockmann HB, Consten EC, Savelkoul PH, Boermeester MA. Fecal microbiome analysis as a diagnostic test for diverticulitis. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):1927-36. doi: 10.1007/s10096-014-2162-3. Epub 2014 Jun 4.
- Background: PubMed 25109425Espin F, Rofes L, Ortega O, Clave P, Gallego D. Nitrergic neuro-muscular transmission is up-regulated in patients with diverticulosis. Neurogastroenterol Motil. 2014 Oct;26(10):1458-68. doi: 10.1111/nmo.12407. Epub 2014 Aug 11.
- Background: PubMed 22276853Humes DJ, Simpson J, Smith J, Sutton P, Zaitoun A, Bush D, Bennett A, Scholefield JH, Spiller RC. Visceral hypersensitivity in symptomatic diverticular disease and the role of neuropeptides and low grade inflammation. Neurogastroenterol Motil. 2012 Apr;24(4):318-e163. doi: 10.1111/j.1365-2982.2011.01863.x. Epub 2012 Jan 25.
- Background: PubMed 22290281Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.
- Background: PubMed 26084881Isacson D, Thorisson A, Andreasson K, Nikberg M, Smedh K, Chabok A. Erratum to: Outpatient, non-antibiotic management in acute uncomplicated diverticulitis: a prospective study. Int J Colorectal Dis. 2015 Sep;30(9):1235. doi: 10.1007/s00384-015-2284-9. No abstract available.
- Background: PubMed 27053254Estrada Ferrer O, Ruiz Edo N, Hidalgo Grau LA, Abadal Prades M, Del Bas Rubia M, Garcia Torralbo EM, Heredia Budo A, Sunol Sala X. Selective non-antibiotic treatment in sigmoid diverticulitis: is it time to change the traditional approach? Tech Coloproctol. 2016 May;20(5):309-315. doi: 10.1007/s10151-016-1464-0. Epub 2016 Apr 6.
- Background: PubMed 27089051Brochmann ND, Schultz JK, Jakobsen GS, Oresland T. Management of acute uncomplicated diverticulitis without antibiotics: a single-centre cohort study. Colorectal Dis. 2016 Nov;18(11):1101-1107. doi: 10.1111/codi.13355.
- Background: PubMed 20646266Unlu C, de Korte N, Daniels L, Consten EC, Cuesta MA, Gerhards MF, van Geloven AA, van der Zaag ES, van der Hoeven JA, Klicks R, Cense HA, Roumen RM, Eijsbouts QA, Lange JF, Fockens P, de Borgie CA, Bemelman WA, Reitsma JB, Stockmann HB, Vrouenraets BC, Boermeester MA; Dutch Diverticular Disease 3D Collaborative Study Group. A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial). BMC Surg. 2010 Jul 20;10:23. doi: 10.1186/1471-2482-10-23.
- Background: PubMed 22549495Andersen JC, Bundgaard L, Elbrond H, Laurberg S, Walker LR, Stovring J; Danish Surgical Society. Danish national guidelines for treatment of diverticular disease. Dan Med J. 2012 May;59(5):C4453.
- Background: PubMed 23969324Andeweg CS, Mulder IM, Felt-Bersma RJ, Verbon A, van der Wilt GJ, van Goor H, Lange JF, Stoker J, Boermeester MA, Bleichrodt RP; Netherlands Society of Surgery; Working group from Netherlands Societies of Internal Medicine, Gastroenterologists, Radiology, Health echnology Assessment and Dieticians. Guidelines of diagnostics and treatment of acute left-sided colonic diverticulitis. Dig Surg. 2013;30(4-6):278-92. doi: 10.1159/000354035. Epub 2013 Aug 20.
- Background: PubMed 25360320Cuomo R, Barbara G, Pace F, Annese V, Bassotti G, Binda GA, Casetti T, Colecchia A, Festi D, Fiocca R, Laghi A, Maconi G, Nascimbeni R, Scarpignato C, Villanacci V, Annibale B. Italian consensus conference for colonic diverticulosis and diverticular disease. United European Gastroenterol J. 2014 Oct;2(5):413-42. doi: 10.1177/2050640614547068.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Diverticulitis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Not yet recruiting
Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
RecruitingPhase 2
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Acute Uncomplicated Diverticulitis
Not yet recruitingObservational study
Analysis of the Role of the Microbiota in Diverticular Disease
Diverticular Disease of Colon, Acute Diverticulitis
RecruitingObservational study
Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
Intra Abdominal Infections, Appendicitis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neus Ruiz, MD principal investigator
Corporacion Parc Tauli
Laura Mora, MD PhD principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen, Acetaminophen and Amoxicillin/clavulanic acid in people with Acute Diverticulitis, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission ratio (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785549, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.