Management and Evolution of Acute Diverticulitis With Pericolic Free Gas

NCT04311385 | Completed

• 1 other identifier: 8_20
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The severity of diverticulitis is usually graded with the use of modified Hinchey Criteria. However, there is a condition often seen in the CT scan that is not included in this classification itself; 1-2 pericolic bubbles but no free air or fluid into the abdomen or above the liver. Outcome in these patients remains unknown. We aim to analyse the treatment that these patients and their evolution over the first year after the diagnosis in order to predict the disease related outcome. The study is set up as a retrospective multicentre observational study. Inclusion criteria are Patients over 18 years old, Diagnosed of acute diverticulitis with a CT scan reported as 1-2 pericolic bubbles with or without free fluid. Exclusion criteria: 1) CT scan showing free distant bubbles in the abdomen. 2) CT scan showing abscess. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 137 subjects are necessary in the observed group to recognize a difference in morbidity greater than or equal to 10%. A proportion in the reference group has been estimated to be 20%. It has been anticipated a drop-out rate of 0%. Primary outcome is 30-day morbidity and mortality. Secondary outcomes include malignancy and 1 year morbidity including recurrences and ongoing disease. Data will be collected in an online repository. The CT scans will be reviewed by 2 experienced independent radiologists. The management of these patients at the moment of the diagnosis will be recorded, as well as their evolution over the first year during the outpatient clinics. Figure 1 represents the study flow chart. Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (01/06/2020 - 31/12/2021). CT scans will be reviewed by 2 experienced radiologists. Every other CT scan performed during the follow-up will be reviewed by the same radiologists. The management of these patients at the moment of the diagnosis will be recorded, as well as their evolution over the first year during the outpatient clinics. This study protocol is a new approach to an unknown entity in diverticulitis. We are convince that the outcomes are clinically relevant to patients and interesting for all physicians treating diverticulitis.

Conditions

Diverticulitis; Diverticulitis Colon; Diverticulitis; Perforation, Bowel; Diverticulitis of Sigmoid

Keywords

Acute diverticulitis; Hinchey; Management of diverticulitis; Treatment of diverticulitis; Diverticulitis classification

Outcome Measures

Primary Outcomes (1)

• 30-day morbidity

  * Diverticulitis recurrence * Perforation (with purulent/fecal peritonitis) * Fistula * Symptomatic colonic stenosis * Intraabdominal abcess * Stoma formation * Emergency surgery or re-operation * Peri- and postoperative complications (Dindo-Clavien classification)

  30 days

Secondary Outcomes (3)

• 30-day mortality

  30 days

• Malignancy

  60 days

• 1-year morbidity

  1 year

Study Arms (1)

Diverticulitis

Patients admitted as an emergency with acute diverticulitis diagnosed by CT scan. Inclusion criteria * Patients over 18 years old * Informed consent form signed * Diagnosed of acute diverticulitis * CT scan reported as 1-2 pericolic bubbles with or without free fluid Exclusion criteria o CT scan showing free distant bubbles in the abdomen

Diagnostic Test: CT imaging

Interventions

CT imaging DIAGNOSTIC_TEST

CT scan reported as 1-2 pericolic bubbles, but no free distant bubbles in the abdomen or abscess.

Diverticulitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency unit Hospitalization

You may qualify if:

• Patients over 18 years old
• Informed consent
• Diagnosed of acute diverticulitis
• CT scan reported as 1-2 pericolic bubbles with or without free fluid.

You may not qualify if:

• CT scan showing free distant bubbles in the abdomen
• CT scan showing abscess

Sponsors & Collaborators

• Hospital Central de la Defensa Gómez Ulla: lead

Study Sites (1)

Hospital Central de la Defensa Gómez Ulla

Madrid, 28047, Spain

Location

Related Publications (17)

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  PMID: 15784040 RESULT

• Jacobs DO. Clinical practice. Diverticulitis. N Engl J Med. 2007 Nov 15;357(20):2057-66. doi: 10.1056/NEJMcp073228. No abstract available.

  PMID: 18003962 RESULT

• Halligan S, Saunders B. Imaging diverticular disease. Best Pract Res Clin Gastroenterol. 2002 Aug;16(4):595-610. doi: 10.1053/bega.2002.0323.

  PMID: 12406453 RESULT

• Farrell RJ, Farrell JJ, Morrin MM. Diverticular disease in the elderly. Gastroenterol Clin North Am. 2001 Jun;30(2):475-96. doi: 10.1016/s0889-8553(05)70191-6.

  PMID: 11432301 RESULT

• Wasvary H, Turfah F, Kadro O, Beauregard W. Same hospitalization resection for acute diverticulitis. Am Surg. 1999 Jul;65(7):632-5; discussion 636.

  PMID: 10399971 RESULT

• Biondo S, Lopez Borao J, Millan M, Kreisler E, Jaurrieta E. Current status of the treatment of acute colonic diverticulitis: a systematic review. Colorectal Dis. 2012 Jan;14(1):e1-e11. doi: 10.1111/j.1463-1318.2011.02766.x.

  PMID: 21848896 RESULT

• Andersen 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.

  PMID: 22549495 RESULT

• Ambrosetti P, Chautems R, Soravia C, Peiris-Waser N, Terrier F. Long-term outcome of mesocolic and pelvic diverticular abscesses of the left colon: a prospective study of 73 cases. Dis Colon Rectum. 2005 Apr;48(4):787-91. doi: 10.1007/s10350-004-0853-z.

  PMID: 15747071 RESULT

• Brandt D, Gervaz P, Durmishi Y, Platon A, Morel P, Poletti PA. Percutaneous CT scan-guided drainage vs. antibiotherapy alone for Hinchey II diverticulitis: a case-control study. Dis Colon Rectum. 2006 Oct;49(10):1533-8. doi: 10.1007/s10350-006-0613-3.

  PMID: 16988856 RESULT

• O'Sullivan GC, Murphy D, O'Brien MG, Ireland A. Laparoscopic management of generalized peritonitis due to perforated colonic diverticula. Am J Surg. 1996 Apr;171(4):432-4. doi: 10.1016/S0002-9610(97)89625-0.

  PMID: 8604837 RESULT

• Sorrentino M, Brizzolari M, Scarpa E, Malisan D, Bruschi F, Bertozzi S, Bernardi S, Petri R. Laparoscopic peritoneal lavage for perforated colonic diverticulitis: a definitive treatment? Retrospective analysis of 63 cases. Tech Coloproctol. 2015 Feb;19(2):105-10. doi: 10.1007/s10151-014-1258-1. Epub 2014 Dec 31.

  PMID: 25550116 RESULT

• Myers E, Hurley M, O'Sullivan GC, Kavanagh D, Wilson I, Winter DC. Laparoscopic peritoneal lavage for generalized peritonitis due to perforated diverticulitis. Br J Surg. 2008 Jan;95(1):97-101. doi: 10.1002/bjs.6024.

  PMID: 18076019 RESULT

• Taylor CJ, Layani L, Ghusn MA, White SI. Perforated diverticulitis managed by laparoscopic lavage. ANZ J Surg. 2006 Nov;76(11):962-5. doi: 10.1111/j.1445-2197.2006.03908.x.

  PMID: 17054542 RESULT

• Angenete E, Thornell A, Burcharth J, Pommergaard HC, Skullman S, Bisgaard T, Jess P, Lackberg Z, Matthiessen P, Heath J, Rosenberg J, Haglind E. Laparoscopic Lavage Is Feasible and Safe for the Treatment of Perforated Diverticulitis With Purulent Peritonitis: The First Results From the Randomized Controlled Trial DILALA. Ann Surg. 2016 Jan;263(1):117-22. doi: 10.1097/SLA.0000000000001061.

  PMID: 25489672 RESULT

• Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland T; SCANDIV Study Group. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1364-75. doi: 10.1001/jama.2015.12076.

  PMID: 26441181 RESULT

• Vennix S, Musters GD, Mulder IM, Swank HA, Consten EC, Belgers EH, van Geloven AA, Gerhards MF, Govaert MJ, van Grevenstein WM, Hoofwijk AG, Kruyt PM, Nienhuijs SW, Boermeester MA, Vermeulen J, van Dieren S, Lange JF, Bemelman WA; Ladies trial colloborators. Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial. Lancet. 2015 Sep 26;386(10000):1269-1277. doi: 10.1016/S0140-6736(15)61168-0. Epub 2015 Jul 22.

  PMID: 26209030 RESULT

• Tejedor P, Pastor C, Pellino G, Di Saverio S, Gorter-Stam M, Sylla P, Francis N; Collaborative Study Group. Management of acute diverticulitis with pericolic free gas (ADIFAS): an international multicenter observational study. Int J Surg. 2023 Apr 1;109(4):689-697. doi: 10.1097/JS9.0000000000000213.

  PMID: 37010145 DERIVED

MeSH Terms

Conditions

Diverticulitis; Diverticulitis, Colonic

Interventions

Postmortem Imaging

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Patricia Tejedor, Consultant

  Hospital Central de la Defensa Gómez Ulla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colorectal Consultant Surgeon

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 17, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)