Diverticulitis ColonSCANDIV-IINCT04254224
Scandinavian Diverticulitis Trial SCANDIV-II
An observational study of Diverticulitis Colon, run by Uppsala University at 1 site in Sweden.
Trial summary
This study focuses on the treatment for complicated diverticulitis classified as Hinchey I-IV. The aim of this prospective observational study is to evaluate type of treatment and the success rate of treatment in acute complicated diverticulitis (ACD) at participating hospitals in Sweden and Norway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis Colon
- What is being tested?
- colon resection, stoma
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 10 Apr 2018to 10 Sep 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients 18 years and older with complicated diverticulitis that are admitted to hospital. Diagnosis verified with computed tomography.
Who may be able to join
- Age ≥18 years
- Clinical symptoms and laboratory results suspicious for diverticulitis
- CT findings of complicated diverticulitis with extraluminal air, presence of abscess with or without fistula or operative findings of complicated diverticulitis in an emergency setting
Who cannot join
- patients with uncomplicated diverticulitis
- unable to give informed consent.
- language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scandinavian Diverticulitis Trial SCANDIV II: Treatment of Acute Complicated Diverticulitis: a Prospective Observational Study
This study focuses on the treatment for complicated diverticulitis classified as Hinchey I-IV.
The aim of this prospective observational study is to evaluate type of treatment and the success rate of treatment in acute complicated diverticulitis (ACD) at participating hospitals in Sweden and Norway. Furthermore, the effects on quality of life for this patient group will be evaluated.
Read the detailed description
Diverticular disease is among the five most common gastrointestinal disorders. Among individuals with diverticulosis the lifetime risk of suffering from diverticulitis is between 4 and 25%. The most common complications of diverticulitis are perforation, abscess formation, fistula and obstruction. Emergency surgery is necessary in up to 25% of diverticulitis patients.
The American Society of Colon and Rectal Surgeon (ASCRS, 2014) recommends abscess drainage and antibiotic treatment and later elective surgery as treatment for complicated diverticulitis, Hinchey I and II (*) for abscesses larger or equal to 5 cm while others recommend resection surgery only for Hinchey II patients. The recommendations for surgery are motivated by the belief that surgical treatment will reduce the risk for relapsing disease with intra-abdominal/pelvic sepsis by more than 40%. However, these recommendations are based on small and out-dated retrospective studies.
Perforated diverticulitis with radiologically confirmed free intraperitoneal air is a life threatening disease with significant mortality and morbidity therefore several guidelines recommend acute surgical intervention. However, a conservative non-surgical approach for the treatment of perforated diverticulitis has been shown to be effective for hemodynamically stable patients with radiologically confirmed free air. A Swedish study recently showed the incidence of complicated diverticulitis to be 9/100.000 inhabitants/year of which about one third required acute surgical intervention. The most common operation in perforated diverticulitis is Hartman's procedure, which involves removal of the involved sigmoid segment, a terminal colostomy and blind closure of the rectal stump. Also primary resection of the sigmoid colon with anastomosis is frequently used, sometimes combined with a loop-ileostomy. Laparoscopic lavage without resection has emerged as an alternative operation method. However, the SCANDIV trial showed limitations of laparoscopic lavage with a higher frequency of re-operation in the lavage group compared to primary resection after 90 days. Nevertheless, several meta-analysis based on three randomized studies showed comparable rates regarding overall mortality and morbidity in laparoscopic lavage versus resection in perforated diverticulitis.
For patients with diverticulitis complicated by fistula (colovesical, colovaginal or colo cutaneous) surgery is the recommended treatment. This condition, however, rarely presents in an acute setting.
In Scandinavia a conservative approach restricted to antibiotics and percutaneous drainage is widely accepted as solitary treatment for patients with diverticular abscesses (Hinchey I and II). Also hemodynamically stable and non-immunocompromised patients with perforated diverticulitis (Hinchey III) are often managed conservatively with antibiotics and, if required, percutaneous drainage. Acute surgical intervention is performed if the condition of the patient deteriorates during hospital stay or if the CT shows signs of faecal peritonitis (Hinchey IV). Elective surgery for patients after an episode of acute complicated diverticulitis (Hinchey I-III) is usually reserved for patients with frequent relapses or with a persisting diverticular abscess.
However, some patients have frequent relapses with abscesses which are difficult to treat and suffer for a long time until the problem is solved. This clinical experience raises the question whether the Scandinavian treatment policy might be too conservative sometimes. Although elective surgery itself can lead to new complications and eventual deterioration in quality of life, early resection might be a better option for some patients. Also the quality of life for patients after conservative management of complicated diverticulitis has not been examined in detail previously.
- I Pericolic abscess II Distant/pelvic abscess III Generalized purulent peritonitis IV Faecal peritonitis
- Conditions
- Diverticulitis Colon
- Being tested
- colon resection, stoma
- Keywords
- Diverticulitis, Surgery, Hinchey, Treatment, Quality of Life
- Medical subject headings
- Diverticulitis, Colonic, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colon resection, stomaProcedure or surgery
Also called Conservative treatment
oral or intravenous antibiotics treatment with or without percutanous or transrectal or transvaginal drainage
| Study group | Role | What they receive |
|---|---|---|
| Diverticulitis Hinchey I-IV | Patients with complicated diverticulitis (Hinchey I-IV) treated conservatively (iv antibiotics with or without percutaneous, transrectal or transvaginal drainage) or surgically. Receives: Procedure: colon resection, stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment in complicated diverticulitis
Surgery or conservative managment
Measured: 1year
Treatment failure
Complications, reoperation, readmission, recurrence , mortality
Measured: 1year
Secondary outcomes (4)
Evaluation of guality of Life
Quality of Life according to Short Health Scale Likert-scale.
Measured: 1 years
Evaluation of guality of Life
Quality of Life according to GIQLI.
Measured: 1 years
Evaluation of guality of Life
Quality of Life according to EQ5D.
Measured: 1 years
Stoma
Proportion of patients with Stoma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start10 Apr 2018
- Primary completion10 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diverticulitis ColonStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Centrallasarettet Västerås, Mora Hospital, Landstinget Dalarna, Uppsala University Hospital, University Hospital, Linkoeping, Danderyd Hospital, Sahlgrenska University Hospital, Stockholm South General Hospital
- Responsible party
- Principal investigator, Abbas Chabok MD, Uppsala University
- Investigators
- Abbas Chabok, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254224
- Sponsor's protocol ID
- 2017/448
- Acronym
- SCANDIV-II
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2019
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Etzioni DA, Mack TM, Beart RW Jr, Kaiser AM. Diverticulitis in the United States: 1998-2005: changing patterns of disease and treatment. Ann Surg. 2009 Feb;249(2):210-7. doi: 10.1097/SLA.0b013e3181952888.
PubMed 19212172Sandler RS, Everhart JE, Donowitz M, Adams E, Cronin K, Goodman C, Gemmen E, Shah S, Avdic A, Rubin R. The burden of selected digestive diseases in the United States. Gastroenterology. 2002 May;122(5):1500-11. doi: 10.1053/gast.2002.32978.
PubMed 11984534Heise CP. Epidemiology and pathogenesis of diverticular disease. J Gastrointest Surg. 2008 Aug;12(8):1309-11. doi: 10.1007/s11605-008-0492-0. Epub 2008 Feb 16.
PubMed 18278535Shahedi K, Fuller G, Bolus R, Cohen E, Vu M, Shah R, Agarwal N, Kaneshiro M, Atia M, Sheen V, Kurzbard N, van Oijen MG, Yen L, Hodgkins P, Erder MH, Spiegel B. Long-term risk of acute diverticulitis among patients with incidental diverticulosis found during colonoscopy. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1609-13. doi: 10.1016/j.cgh.2013.06.020. Epub 2013 Jul 12.
PubMed 23856358Morris AM, Regenbogen SE, Hardiman KM, Hendren S. Sigmoid diverticulitis: a systematic review. JAMA. 2014 Jan 15;311(3):287-97. doi: 10.1001/jama.2013.282025.
PubMed 24430321Abbas S. Resection and primary anastomosis in acute complicated diverticulitis, a systematic review of the literature. Int J Colorectal Dis. 2007 Apr;22(4):351-7. doi: 10.1007/s00384-005-0059-4. Epub 2006 Jan 7.
PubMed 16437211Feingold D, Steele SR, Lee S, Kaiser A, Boushey R, Buie WD, Rafferty JF. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014 Mar;57(3):284-94. doi: 10.1097/DCR.0000000000000075. No abstract available.
PubMed 24509449Hinchey EJ, Schaal PG, Richards GK. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109.
PubMed 735943Ambrosetti P, Becker C, Terrier F. Colonic diverticulitis: impact of imaging on surgical management -- a prospective study of 542 patients. Eur Radiol. 2002 May;12(5):1145-9. doi: 10.1007/s00330-001-1143-y. Epub 2001 Nov 8.
PubMed 11976860Kaiser AM, Jiang JK, Lake JP, Ault G, Artinyan A, Gonzalez-Ruiz C, Essani R, Beart RW Jr. The management of complicated diverticulitis and the role of computed tomography. Am J Gastroenterol. 2005 Apr;100(4):910-7. doi: 10.1111/j.1572-0241.2005.41154.x.
PubMed 15784040Angenete E, Bock D, Rosenberg J, Haglind E. Laparoscopic lavage is superior to colon resection for perforated purulent diverticulitis-a meta-analysis. Int J Colorectal Dis. 2017 Feb;32(2):163-169. doi: 10.1007/s00384-016-2636-0. Epub 2016 Aug 27.
PubMed 27567926Ceresoli M, Coccolini F, Montori G, Catena F, Sartelli M, Ansaloni L. Laparoscopic lavage versus resection in perforated diverticulitis with purulent peritonitis: a meta-analysis of randomized controlled trials. World J Emerg Surg. 2016 Aug 30;11(1):42. doi: 10.1186/s13017-016-0103-4. eCollection 2016.
PubMed 27582782Cirocchi R, Di Saverio S, Weber DG, Tabola R, Abraha I, Randolph J, Arezzo A, Binda GA. Laparoscopic lavage versus surgical resection for acute diverticulitis with generalised peritonitis: a systematic review and meta-analysis. Tech Coloproctol. 2017 Feb;21(2):93-110. doi: 10.1007/s10151-017-1585-0. Epub 2017 Feb 15.
PubMed 28197792Marshall JR, Buchwald PL, Gandhi J, Schultz JK, Hider PN, Frizelle FA, Eglinton TW. Laparoscopic Lavage in the Management of Hinchey Grade III Diverticulitis: A Systematic Review. Ann Surg. 2017 Apr;265(4):670-676. doi: 10.1097/SLA.0000000000002005.
PubMed 27631772Elliott PA, McLemore EC, Abbass MA, Abbas MA. Robotic versus laparoscopic resection for sigmoid diverticulitis with fistula. J Robot Surg. 2015 Jun;9(2):137-42. doi: 10.1007/s11701-015-0503-6. Epub 2015 Feb 26.
PubMed 26531114
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Diverticulitis Trial SCANDIV II: Treatment of Acute Complicated Diverticulitis: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04254224
- Acronym / sponsor ID
- SCANDIV-II / 2017/448
- Conditions
- Diverticulitis Colon
- Keywords
- Diverticulitis, Surgery, Hinchey, Treatment, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Centrallasarettet Västerås, Mora Hospital, Landstinget Dalarna, Uppsala University Hospital, University Hospital, Linkoeping, Danderyd Hospital, Sahlgrenska University Hospital, Stockholm South General Hospital
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 5 Feb 2020 (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.
This study focuses on the treatment for complicated diverticulitis classified as Hinchey I-IV.
The aim of this prospective observational study is to evaluate type of treatment and the success rate of treatment in acute complicated diverticulitis (ACD) at participating hospitals in Sweden and Norway. Furthermore, the effects on quality of life for this patient group will be evaluated.
Detailed description
Diverticular disease is among the five most common gastrointestinal disorders. Among individuals with diverticulosis the lifetime risk of suffering from diverticulitis is between 4 and 25%. The most common complications of diverticulitis are perforation, abscess formation, fistula and obstruction. Emergency surgery is necessary in up to 25% of diverticulitis patients.
The American Society of Colon and Rectal Surgeon (ASCRS, 2014) recommends abscess drainage and antibiotic treatment and later elective surgery as treatment for complicated diverticulitis, Hinchey I and II (*) for abscesses larger or equal to 5 cm while others recommend resection surgery only for Hinchey II patients. The recommendations for surgery are motivated by the belief that surgical treatment will reduce the risk for relapsing disease with intra-abdominal/pelvic sepsis by more than 40%. However, these recommendations are based on small and out-dated retrospective studies.
Perforated diverticulitis with radiologically confirmed free intraperitoneal air is a life threatening disease with significant mortality and morbidity therefore several guidelines recommend acute surgical intervention. However, a conservative non-surgical approach for the treatment of perforated diverticulitis has been shown to be effective for hemodynamically stable patients with radiologically confirmed free air. A Swedish study recently showed the incidence of complicated diverticulitis to be 9/100.000 inhabitants/year of which about one third required acute surgical intervention. The most common operation in perforated diverticulitis is Hartman's procedure, which involves removal of the involved sigmoid segment, a terminal colostomy and blind closure of the rectal stump. Also primary resection of the sigmoid colon with anastomosis is frequently used, sometimes combined with a loop-ileostomy. Laparoscopic lavage without resection has emerged as an alternative operation method. However, the SCANDIV trial showed limitations of laparoscopic lavage with a higher frequency of re-operation in the lavage group compared to primary resection after 90 days. Nevertheless, several meta-analysis based on three randomized studies showed comparable rates regarding overall mortality and morbidity in laparoscopic lavage versus resection in perforated diverticulitis.
For patients with diverticulitis complicated by fistula (colovesical, colovaginal or colo cutaneous) surgery is the recommended treatment. This condition, however, rarely presents in an acute setting.
In Scandinavia a conservative approach restricted to antibiotics and percutaneous drainage is widely accepted as solitary treatment for patients with diverticular abscesses (Hinchey I and II). Also hemodynamically stable and non-immunocompromised patients with perforated diverticulitis (Hinchey III) are often managed conservatively with antibiotics and, if required, percutaneous drainage. Acute surgical intervention is performed if the condition of the patient deteriorates during hospital stay or if the CT shows signs of faecal peritonitis (Hinchey IV). Elective surgery for patients after an episode of acute complicated diverticulitis (Hinchey I-III) is usually reserved for patients with frequent relapses or with a persisting diverticular abscess.
However, some patients have frequent relapses with abscesses which are difficult to treat and suffer for a long time until the problem is solved. This clinical experience raises the question whether the Scandinavian treatment policy might be too conservative sometimes. Although elective surgery itself can lead to new complications and eventual deterioration in quality of life, early resection might be a better option for some patients. Also the quality of life for patients after conservative management of complicated diverticulitis has not been examined in detail previously.
- I Pericolic abscess II Distant/pelvic abscess III Generalized purulent peritonitis IV Faecal peritonitis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diverticulitis Hinchey I-IV | – | Procedure: colon resection, stomaPatients with complicated diverticulitis (Hinchey I-IV) treated conservatively (iv antibiotics with or without percutaneous, transrectal or transvaginal drainage) or surgically. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 18 years and older with complicated diverticulitis that are admitted to hospital. Diagnosis verified with computed tomography.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Clinical symptoms and laboratory results suspicious for diverticulitis
- CT findings of complicated diverticulitis with extraluminal air, presence of abscess with or without fistula or operative findings of complicated diverticulitis in an emergency setting
Key exclusion criteria (3 listed)
- patients with uncomplicated diverticulitis
- unable to give informed consent.
- language barrier
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 |
|---|---|---|
| colon resection, stomaAlso: Conservative treatmentoral or intravenous antibiotics treatment with or without percutanous or transrectal or transvaginal drainage | Procedure or surgery | Diverticulitis Hinchey I-IV |
Primary outcome
Treatment in complicated diverticulitis
Time frame: 1year
Surgery or conservative managment
Treatment failure
Time frame: 1year
Complications, reoperation, readmission, recurrence , mortality
4 secondary outcomes
Evaluation of guality of Life
Time frame: 1 years
Evaluation of guality of Life
Time frame: 1 years
Evaluation of guality of Life
Time frame: 1 years
Stoma
Time frame: 1 year
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 2 Oct 2026.
- Background: PubMed 19212172Etzioni DA, Mack TM, Beart RW Jr, Kaiser AM. Diverticulitis in the United States: 1998-2005: changing patterns of disease and treatment. Ann Surg. 2009 Feb;249(2):210-7. doi: 10.1097/SLA.0b013e3181952888.
- Background: PubMed 11984534Sandler RS, Everhart JE, Donowitz M, Adams E, Cronin K, Goodman C, Gemmen E, Shah S, Avdic A, Rubin R. The burden of selected digestive diseases in the United States. Gastroenterology. 2002 May;122(5):1500-11. doi: 10.1053/gast.2002.32978.
- Background: PubMed 18278535Heise CP. Epidemiology and pathogenesis of diverticular disease. J Gastrointest Surg. 2008 Aug;12(8):1309-11. doi: 10.1007/s11605-008-0492-0. Epub 2008 Feb 16.
- Background: PubMed 23856358Shahedi K, Fuller G, Bolus R, Cohen E, Vu M, Shah R, Agarwal N, Kaneshiro M, Atia M, Sheen V, Kurzbard N, van Oijen MG, Yen L, Hodgkins P, Erder MH, Spiegel B. Long-term risk of acute diverticulitis among patients with incidental diverticulosis found during colonoscopy. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1609-13. doi: 10.1016/j.cgh.2013.06.020. Epub 2013 Jul 12.
- Background: PubMed 24430321Morris AM, Regenbogen SE, Hardiman KM, Hendren S. Sigmoid diverticulitis: a systematic review. JAMA. 2014 Jan 15;311(3):287-97. doi: 10.1001/jama.2013.282025.
- Background: PubMed 16437211Abbas S. Resection and primary anastomosis in acute complicated diverticulitis, a systematic review of the literature. Int J Colorectal Dis. 2007 Apr;22(4):351-7. doi: 10.1007/s00384-005-0059-4. Epub 2006 Jan 7.
- Background: PubMed 24509449Feingold D, Steele SR, Lee S, Kaiser A, Boushey R, Buie WD, Rafferty JF. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014 Mar;57(3):284-94. doi: 10.1097/DCR.0000000000000075. No abstract available.
- Background: PubMed 735943Hinchey EJ, Schaal PG, Richards GK. Treatment of perforated diverticular disease of the colon. Adv Surg. 1978;12:85-109.
- Background: PubMed 11976860Ambrosetti P, Becker C, Terrier F. Colonic diverticulitis: impact of imaging on surgical management -- a prospective study of 542 patients. Eur Radiol. 2002 May;12(5):1145-9. doi: 10.1007/s00330-001-1143-y. Epub 2001 Nov 8.
- Background: PubMed 15784040Kaiser AM, Jiang JK, Lake JP, Ault G, Artinyan A, Gonzalez-Ruiz C, Essani R, Beart RW Jr. The management of complicated diverticulitis and the role of computed tomography. Am J Gastroenterol. 2005 Apr;100(4):910-7. doi: 10.1111/j.1572-0241.2005.41154.x.
- Background: PubMed 27567926Angenete E, Bock D, Rosenberg J, Haglind E. Laparoscopic lavage is superior to colon resection for perforated purulent diverticulitis-a meta-analysis. Int J Colorectal Dis. 2017 Feb;32(2):163-169. doi: 10.1007/s00384-016-2636-0. Epub 2016 Aug 27.
- Background: PubMed 27582782Ceresoli M, Coccolini F, Montori G, Catena F, Sartelli M, Ansaloni L. Laparoscopic lavage versus resection in perforated diverticulitis with purulent peritonitis: a meta-analysis of randomized controlled trials. World J Emerg Surg. 2016 Aug 30;11(1):42. doi: 10.1186/s13017-016-0103-4. eCollection 2016.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Abbas Chabok, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis Colon, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 3 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 2 Oct 2026. 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 Sweden. 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?
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?
Treatment in complicated diverticulitis (time frame: 1year). The study lists 2 primary outcomes in all. 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 NCT04254224, which also lists 17 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 2 Oct 2026.