An interventional study of Surgical reserction and Radiological percutaneous drainage and washing drainage in Peritonitis and Diverticulitis, sponsored by University Hospital, Strasbourg, France. Status unknown at 14 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-23.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment
Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and infection sets in around the diverticulum the condition is called diverticulitis. An individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent hospitalisations as a result of the evolution of purulent peritonitis that originates from diverticulitis treated by mini-invasive surgery results.
Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic generalized purulent peritonitis of diverticular origin have been identified as therapeutic options by HAS (French health authorities), followed by second stage resection-anastomosis under elective surgery. It has been observed in patients that if only drainage and washing are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore this reduces the risks of postoperatory complications.
Some studies have shown that the attitude of non-distance resection of the acute episode was associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity. In addition, the morbidity associated with intervention sigmoid resection is around 30%.
The question arises in our daily practice, or not to propose systematic resection of sigmoid diverticulitis after an acute episode of severe purulent peritonitis or abscess types supported initially by minimally invasive.
The primary objective of the study is to determine, after clinical improvement linked to conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as currently recommended.
The secondary objective of the study is to determine if conservative treatment reduces mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and improves quality of life.
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's planned enrollment of 120 is above the median of 95 across 118 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
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Exclusion Criteria:
Standard of care arm : sigmoid reserction after randomisation
Procedure: Surgical reserction
laproscopic drainage and washing
Other: Radiological percutaneous drainage and washing drainage
Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity
The primary endpoint is the composite as predictable morbidity is different between groups. It is the occurrence of a disease episode in connection with diverticulosis or its treatment: recurrence of diverticulitis, the need for intervention in the sigmoid resection group drawn for a conservative attitude, postoperative complications Dindo stage ≥ II in case of sigmoid
Time frame: 2 years
Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients
The secondary endpoints were mortality, the number and duration of cumulative report with sigmoid diverticular disease hospitalization, quality of life (SF-36 questionnaire, and QLQ CR29)
Time frame: 2 years
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University Hospital, Strasbourg, France