Diverticulitis, ColonicADIANANCT06517264

Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics

A study testing Antibiotic and Non antibiotic in people with Diverticulitis, Colonic, run by Monica Mengual Ballester at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The objective of this clinical trial to evaluate the effectiveness and safety of outpatient treatment without antibiotics compared to outpatient treatment with antibiotics in patients with acute uncomplicated diverticulitis. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diverticulitis, Colonic
What is being tested?: Antibiotic and Non antibiotic
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 282 participants
Where: 1 siteSpain
Study dates: 1 Nov 2024to 30 Apr 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Patients over 18 years old with clinical and radiological diagnosis of acute sigmoid or descending colon diverticulitis (left-sided acute diverticulitis) not complicated.
Radiological diagnosis of acute uncomplicated diverticulitis by CT (Modified Hinchey Classification 0-Ia).
First episode or previous history of acute diverticulitis (both complicated and uncomplicated), with ≥6 months between the last episode and the current clinical presentation).
Informed consent to participate in the study.

Who cannot join

Age >80 years.
Patients eligible for hospital admission and/or intravenous antibiotic therapy (at the time of diagnosis).
Repeated vomiting or oral intolerance.
Need for intravenous fluid therapy and/or close monitoring.
Peripheral body temperature >38ºC.
Deterioration of general condition and/or clinical suspicion of sepsis.

Show all 12Show fewer

Significant or decompensated comorbidity: ASA IV Classification (anesthetic risk of American Society of Anesthesiologists).
Immunocompromised patients: Hematological cause, HIV with low CD4+ levels, immunosuppressive treatment, prolonged corticosteroid therapy, chemotherapy, transplanted or splenectomized patients, predisposing genetic alterations (severe combined immunodeficiency, etc.).
Oral or intravenous antibiotic therapy 2 weeks before the onset of symptoms for another cause.
Pregnancy.
Inflammatory bowel disease (Crohn's disease, ulcerative colitis).
Lack of social and home support making outpatient treatment and follow-up impossible.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

Monica Mengual
Murcia, 30007

Other trials in Spain

About this study

Official title: Multicenter Clinical Trial on the Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics Compared to Treatment With Antibiotics. ADIANA TRIAL

The hypotheses are:

Null Hypothesis (H0): Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is neither safe nor effective and is inferior to outpatient management with antibiotics.
Alternative Hypothesis (H1): Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is safe, effective, and not inferior to outpatient management with antibiotics.

We compare the rate of complications, therapeutic failure (clinical worsening and readmission) and recurrence between patients who, on an outpatient basis, are administered antibiotics and those who are not.

The patient diagnosed with acute uncomplicated diverticulitis who meets the inclusion criteria is evaluated and examined by a general surgeon. After informing him/her about the pathology, the study will be explained and he/she will be invited to freely participate in it. After accepting and signing the informed consent form, the patient will be included in the study and will be randomly assigned to one of the two treatment arms (outpatient treatment with antibiotics (group A) or without antibiotics (group B).

Read the detailed description

The surgeon must reassess the patient at 72 hours, with a complete history of the new clinical status, physical examination, and blood tests (with the same parameters). This visit will check treatment adherence and early clinical response. If the patient shows unfavorable progress or clear clinical deterioration, a new imaging test will be considered, and the assigned therapeutic option will be considered a failure. Follow-up will be completed with a face-to-face consultation one month after the episode and another (face-to-face or telematic) at six months.

Conditions: Diverticulitis, Colonic
Being tested: Antibiotic, Non antibiotic
Keywords: diverticular disease, uncomplicated diverticulitis, diverticular inflammation
Medical subject headings: Diverticulitis, Colonic, Diverticular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AntibioticDrug
Also called Group A
antibiotic treatment, analgesics and hygienic-dietetic measures
Non antibioticOther
Also called Group B
Analgesics and hygienic-dietetic measures

Study groups in NCT06517264
Study group	Role	What they receive
Outpatient treatment with antibiotics (group A)	Active comparator	If belonging to group A (receiving oral antibiotic therapy), the usual oral antibiotic regimen of each center will be indicated. According to according to the guidelines of our hospital: * 3rd generation cephalosporin (e.g., Cefditoren 200 mg, one tablet every 12 hours) + Metronidazole 500 mg, two tablets every 8 hours. Duration of treatment: 7 days. * Penicillin allergy: Ciprofloxacin 500 mg, one tablet every 12 hours + Metronidazole 500 mg, two tablets every 8 hours. Duration of treatment: 7 days. Hygienic-dietary measures: * Low-residue diet for the first 48 hours. An informative leaflet will be provided to clarify these recommendations. * Adequate oral hydration during the episode. * Paracetamol 1 gram orally, one tablet every 8 hours. If pain persists, alternate every 4 hours Paracetamol with Metamizole 575 mg, one tablet every 8 hours. If allergic to Metamizole, it can be substituted with Dexketoprofen 25 mg, one tablet every 8 hours. Receives: Drug: Antibiotic
Outpatient treatment without antibiotics (group B)	Other	Hygienic-dietary measures: * Low-residue diet for the first 48 hours. An informative leaflet will be provided to clarify these recommendations. * Adequate oral hydration during the episode. * Paracetamol 1 gram orally, one tablet every 8 hours. If pain persists, alternate every 4 hours Paracetamol with Metamizole 575 mg, one tablet every 8 hours. If allergic to Metamizole, it can be substituted with Dexketoprofen 25 mg, one tablet every 8 hours. Receives: Other: Non antibiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis
Therapeutic failure is considered when the patient reconsults before 72 hours due to unfavorable progress or clinical deterioration requiring admission.
Measured: 1 month

Secondary outcomes (4)

Evaluate and contrast the outcomes in terms of recurrence between outpatient treatment with and without antibiotics.
recurrence is defined as a new episode of diverticulitis after a period of 12 weeks without symptoms.
Measured: 6 months
Evaluate and contrast the outcomes in terms of cost-effectiveness between outpatient treatment with and without antibiotics.
We reduce the costs derived from antibiotic treatment and its possible side effects with the same cure rates.
Measured: 6 months
Study the risk factors for bad prognosis in patients with uncomplicated diverticulitis
Study the risk factors for diverticulitis and prognostic factors of therapeutic failure and progression to complicated diverticulitis
Measured: 6 months
Evaluate the quality of life of these patients after the acute episode and the degree of satisfaction with the treatment received.
It will be assessed with the acute diverticulitis episode-related quality of life test (EuroQol-5D).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202430 Apr 2026

First posted24 Jul 2024
Study start1 Nov 2024
Primary completion30 Apr 2026 (estimated)
Study completion30 Apr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Diverticulitis, ColonicStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicenter, controlled, randomized, and open-label study (without blinding) with two treatment arms.
Masking: None (open label)
Enrolment: 282 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06517264
Sponsor's protocol ID: DIVERT-ADIANA
Acronym: ADIANA
Status last verified: Feb 2025
First submitted: 18 Jul 2024
Last updated: 25 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bolkenstein HE, Draaisma WA, van de Wall B, Consten E, Broeders I. Treatment of acute uncomplicated diverticulitis without antibiotics: risk factors for treatment failure. Int J Colorectal Dis. 2018 Jul;33(7):863-869. doi: 10.1007/s00384-018-3055-1. Epub 2018 Apr 21.
PubMed 29679152
Unlu 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 20646266
Hanna MH, Kaiser AM. Update on the management of sigmoid diverticulitis. World J Gastroenterol. 2021 Mar 7;27(9):760-781. doi: 10.3748/wjg.v27.i9.760.
PubMed 33727769
You H, Sweeny A, Cooper ML, Von Papen M, Innes J. The management of diverticulitis: a review of the guidelines. Med J Aust. 2019 Nov;211(9):421-427. doi: 10.5694/mja2.50276. Epub 2019 Jul 28.
PubMed 31352692
Francis NK, Sylla P, Abou-Khalil M, Arolfo S, Berler D, Curtis NJ, Dolejs SC, Garfinkle R, Gorter-Stam M, Hashimoto DA, Hassinger TE, Molenaar CJL, Pucher PH, Schuermans V, Arezzo A, Agresta F, Antoniou SA, Arulampalam T, Boutros M, Bouvy N, Campbell K, Francone T, Haggerty SP, Hedrick TL, Stefanidis D, Truitt MS, Kelly J, Ket H, Dunkin BJ, Pietrabissa A. EAES and SAGES 2018 consensus conference on acute diverticulitis management: evidence-based recommendations for clinical practice. Surg Endosc. 2019 Sep;33(9):2726-2741. doi: 10.1007/s00464-019-06882-z. Epub 2019 Jun 27.
PubMed 31250244
Jaung R, Nisbet S, Gosselink MP, Di Re A, Keane C, Lin A, Milne T, Su'a B, Rajaratnam S, Ctercteko G, Hsee L, Rowbotham D, Hill A, Bissett I. Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial. Clin Gastroenterol Hepatol. 2021 Mar;19(3):503-510.e1. doi: 10.1016/j.cgh.2020.03.049. Epub 2020 Mar 30.
PubMed 32240832
Chabok 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 22290281
Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.
PubMed 18523784
van Dijk ST, Chabok A, Dijkgraaf MG, Boermeester MA, Smedh K. Observational versus antibiotic treatment for uncomplicated diverticulitis: an individual-patient data meta-analysis. Br J Surg. 2020 Jul;107(8):1062-1069. doi: 10.1002/bjs.11465. Epub 2020 Feb 19.
PubMed 32073652
Mari A, Khoury T, Lubany A, Safadi M, Farraj M, Farah A, Kadah A, Sbeit W, Mahamid M. Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Correlated with Complicated Diverticulitis and Hinchey Classification: A Simple Tool to Assess Disease Severity in the Emergency Department. Emerg Med Int. 2019 Aug 14;2019:6321060. doi: 10.1155/2019/6321060. eCollection 2019.
PubMed 31485352
Biondo S, Golda T, Kreisler E, Espin E, Vallribera F, Oteiza F, Codina-Cazador A, Pujadas M, Flor B. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial). Ann Surg. 2014 Jan;259(1):38-44. doi: 10.1097/SLA.0b013e3182965a11.
PubMed 23732265
Biondo S, Golda T. Enfermedad diverticular del colon. En: Parrilla P, García-Granero E, Martín E, Morales-Conde S, Navarro S, Targarona EM, editores. Cirugía AEC. 3ª edición. Madrid: Editorial Médica Panamericana, S.A; 2022. p. 547-556
Álvarez C, Arencibia B, Balibrea del Castillo JM, Cerdán C, Dujovne P, Durán V, et al. Monografías de la AEC: Enfermedad Diverticular y Diverticulitis Aguda. Serie nº14. Madrid: Asociación Española de Cirujanos; 2022. p.15-131

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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RecruitingObservational study
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All Diverticulitis, Colonic trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Clinical Trial on the Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics Compared to Treatment With Antibiotics. ADIANA TRIAL
ClinicalTrials.gov ID: NCT06517264
Acronym / sponsor ID: ADIANA / DIVERT-ADIANA
Conditions: Diverticulitis, Colonic
Keywords: diverticular disease, uncomplicated diverticulitis, diverticular inflammation
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 282 participants (estimated)
Lead sponsor: Monica Mengual BallesterUniversity, hospital or other
Study start: 1 Nov 2024 (actual)
Primary completion: 30 Apr 2026 (estimated)
Study completion: 30 Apr 2026 (estimated)
First posted: 24 Jul 2024 (actual)
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.

The hypotheses are:

Null Hypothesis (H0): Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is neither safe nor effective and is inferior to outpatient management with antibiotics.
Alternative Hypothesis (H1): Outpatient treatment without antibiotics in patients with acute uncomplicated diverticulitis is safe, effective, and not inferior to outpatient management with antibiotics.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Multicenter, controlled, randomized, and open-label study (without blinding) with two treatment arms.

Arm	Type	Receives
Outpatient treatment with antibiotics (group A)	Active comparator	Drug: AntibioticIf belonging to group A (receiving oral antibiotic therapy), the usual oral antibiotic regimen of each center will be indicated. According to according to the guidelines of our hospital: * 3rd generation cephalosporin (e.g., Cefditoren 200 mg, one tablet every 12 hours) + Metronidazole 500 mg, two tablets every 8 hours. Duration of treatment: 7 days. * Penicillin allergy: Ciprofloxacin 500 mg, one tablet every 12 hours + Metronidazole 500 mg, two tablets every 8 hours. Duration of treatment: 7 days. Hygienic-dietary measures: * Low-residue diet for the first 48 hours. An informative leaflet will be provided to clarify these recommendations. * Adequate oral hydration during the episode. * Paracetamol 1 gram orally, one tablet every 8 hours. If pain persists, alternate every 4 hours Paracetamol with Metamizole 575 mg, one tablet every 8 hours. If allergic to Metamizole, it can be substituted with Dexketoprofen 25 mg, one tablet every 8 hours.
Outpatient treatment without antibiotics (group B)	Other	Other: Non antibioticHygienic-dietary measures: * Low-residue diet for the first 48 hours. An informative leaflet will be provided to clarify these recommendations. * Adequate oral hydration during the episode. * Paracetamol 1 gram orally, one tablet every 8 hours. If pain persists, alternate every 4 hours Paracetamol with Metamizole 575 mg, one tablet every 8 hours. If allergic to Metamizole, it can be substituted with Dexketoprofen 25 mg, one tablet every 8 hours.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients over 18 years old with clinical and radiological diagnosis of acute sigmoid or descending colon diverticulitis (left-sided acute diverticulitis) not complicated.
Radiological diagnosis of acute uncomplicated diverticulitis by CT (Modified Hinchey Classification 0-Ia).
First episode or previous history of acute diverticulitis (both complicated and uncomplicated), with ≥6 months between the last episode and the current clinical presentation).
Informed consent to participate in the study.

Key exclusion criteria (12 listed)

Age >80 years.
Patients eligible for hospital admission and/or intravenous antibiotic therapy (at the time of diagnosis).
Significant or decompensated comorbidity: ASA IV Classification (anesthetic risk of American Society of Anesthesiologists).
Immunocompromised patients: Hematological cause, HIV with low CD4+ levels, immunosuppressive treatment, prolonged corticosteroid therapy, chemotherapy, transplanted or splenectomized patients, predisposing genetic alterations (severe combined immunodeficiency, etc.).
Oral or intravenous antibiotic therapy 2 weeks before the onset of symptoms for another cause.

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
AntibioticAlso: Group Aantibiotic treatment, analgesics and hygienic-dietetic measures	Drug	Outpatient treatment with antibiotics (group A)
Non antibioticAlso: Group BAnalgesics and hygienic-dietetic measures	Other	Outpatient treatment without antibiotics (group B)

Primary outcome

Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis
Time frame: 1 month
Therapeutic failure is considered when the patient reconsults before 72 hours due to unfavorable progress or clinical deterioration requiring admission.

4 secondary outcomes

Evaluate and contrast the outcomes in terms of recurrence between outpatient treatment with and without antibiotics.
Time frame: 6 months
Evaluate and contrast the outcomes in terms of cost-effectiveness between outpatient treatment with and without antibiotics.
Time frame: 6 months
Study the risk factors for bad prognosis in patients with uncomplicated diverticulitis
Time frame: 6 months
Evaluate the quality of life of these patients after the acute episode and the degree of satisfaction with the treatment received.
Time frame: 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
Results publication: PubMed 29679152Bolkenstein HE, Draaisma WA, van de Wall B, Consten E, Broeders I. Treatment of acute uncomplicated diverticulitis without antibiotics: risk factors for treatment failure. Int J Colorectal Dis. 2018 Jul;33(7):863-869. doi: 10.1007/s00384-018-3055-1. Epub 2018 Apr 21.
Results publication: 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.
Results publication: PubMed 33727769Hanna MH, Kaiser AM. Update on the management of sigmoid diverticulitis. World J Gastroenterol. 2021 Mar 7;27(9):760-781. doi: 10.3748/wjg.v27.i9.760.
Results publication: PubMed 31352692You H, Sweeny A, Cooper ML, Von Papen M, Innes J. The management of diverticulitis: a review of the guidelines. Med J Aust. 2019 Nov;211(9):421-427. doi: 10.5694/mja2.50276. Epub 2019 Jul 28.
Results publication: PubMed 31250244Francis NK, Sylla P, Abou-Khalil M, Arolfo S, Berler D, Curtis NJ, Dolejs SC, Garfinkle R, Gorter-Stam M, Hashimoto DA, Hassinger TE, Molenaar CJL, Pucher PH, Schuermans V, Arezzo A, Agresta F, Antoniou SA, Arulampalam T, Boutros M, Bouvy N, Campbell K, Francone T, Haggerty SP, Hedrick TL, Stefanidis D, Truitt MS, Kelly J, Ket H, Dunkin BJ, Pietrabissa A. EAES and SAGES 2018 consensus conference on acute diverticulitis management: evidence-based recommendations for clinical practice. Surg Endosc. 2019 Sep;33(9):2726-2741. doi: 10.1007/s00464-019-06882-z. Epub 2019 Jun 27.
Results publication: PubMed 32240832Jaung R, Nisbet S, Gosselink MP, Di Re A, Keane C, Lin A, Milne T, Su'a B, Rajaratnam S, Ctercteko G, Hsee L, Rowbotham D, Hill A, Bissett I. Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial. Clin Gastroenterol Hepatol. 2021 Mar;19(3):503-510.e1. doi: 10.1016/j.cgh.2020.03.049. Epub 2020 Mar 30.
Results publication: 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.
Results publication: PubMed 18523784Lameris W, van Randen A, Bipat S, Bossuyt PM, Boermeester MA, Stoker J. Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: meta-analysis of test accuracy. Eur Radiol. 2008 Nov;18(11):2498-511. doi: 10.1007/s00330-008-1018-6. Epub 2008 Jun 4.
Results publication: PubMed 32073652van Dijk ST, Chabok A, Dijkgraaf MG, Boermeester MA, Smedh K. Observational versus antibiotic treatment for uncomplicated diverticulitis: an individual-patient data meta-analysis. Br J Surg. 2020 Jul;107(8):1062-1069. doi: 10.1002/bjs.11465. Epub 2020 Feb 19.
Results publication: PubMed 31485352Mari A, Khoury T, Lubany A, Safadi M, Farraj M, Farah A, Kadah A, Sbeit W, Mahamid M. Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Correlated with Complicated Diverticulitis and Hinchey Classification: A Simple Tool to Assess Disease Severity in the Emergency Department. Emerg Med Int. 2019 Aug 14;2019:6321060. doi: 10.1155/2019/6321060. eCollection 2019.
Results publication: PubMed 23732265Biondo S, Golda T, Kreisler E, Espin E, Vallribera F, Oteiza F, Codina-Cazador A, Pujadas M, Flor B. Outpatient versus hospitalization management for uncomplicated diverticulitis: a prospective, multicenter randomized clinical trial (DIVER Trial). Ann Surg. 2014 Jan;259(1):38-44. doi: 10.1097/SLA.0b013e3182965a11.
Results publicationBiondo S, Golda T. Enfermedad diverticular del colon. En: Parrilla P, García-Granero E, Martín E, Morales-Conde S, Navarro S, Targarona EM, editores. Cirugía AEC. 3ª edición. Madrid: Editorial Médica Panamericana, S.A; 2022. p. 547-556
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Antibiotic and Non antibiotic in people with Diverticulitis, Colonic, run by Monica Mengual Ballester 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 4 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 25 Feb 2025. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Evaluate the effectiveness and safety of outpatient treatment without antibiotics in patients with uncomplicated diverticulitis (time frame: 1 month). 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 NCT06517264, which also lists 13 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 25 Feb 2025.