Diverticulitis Colon Clinical Trial
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04311385 -
Management and Evolution of Acute Diverticulitis With Pericolic Free Gas
|
||
| Recruiting |
NCT05393609 -
Quality of Life and Surgery in Diverticular Disease
|
||
| Withdrawn |
NCT03448874 -
Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]
|
N/A |