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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sigmoidectomy arm | Other | Standard of care arm : sigmoid reserction after randomisation |
|
| Control arm | Experimental | laproscopic drainage and washing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical reserction | Procedure |
| ||
| Radiological percutaneous drainage and washing drainage |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile BRIGAND, MD, PHD | Contact | 03 88 12 72 26 | Cecile.brigand@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Catherine ARVIEUX, MD,PHD | Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217 | Principal Investigator |
| Cécile BRIGAND, MD, PHD | Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chirurgie générale et digestive,Hôpital de Hautepierre, | Not yet recruiting | Strasbourg | Alsace | 67098 | France |
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| Other |
|
| Sébastien DAN, MD | Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec | Principal Investigator |
| David GUINIER, MD | Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 Lorient | Principal Investigator |
| Mehdi KAROUI, MD | Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,Créteil | Principal Investigator |
| Christophe MARIETTE, MD,PHD | chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille Cedex | Principal Investigator |
| MSIKA Simon, MD | Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 Colombes | Principal Investigator |
| MUSCARI Fabrice, MD, PHD | Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 - TOULOUSE CEDEX | Principal Investigator |
| Marc POCARD, MD, PHD | Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10 | Principal Investigator |
| REGIMBEAU Jean Marc, MD | CHU Amiens Nord Place Victor, Pauchet 80054 Amiens | Principal Investigator |
| Didier RIO, MD | Service de chirurgie digestive et viscérale, Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, 56000 Vannes | Principal Investigator |
| Karim SLIM, MD,PHD | Service de chirurgie digestive Hotel Dieu, Bd Léon Malfreyt | Principal Investigator |
| Bertrand SUC, MD | Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire de TOULOUSE - RANGUEIL Avenue Jean Poulhes 31054 - TOULOUSE CEDEX | Principal Investigator |
| Clinique Universitaire de Chirurgie Digestive et de l'Urgence | Not yet recruiting | Grenoble | CHU de Grenoble | BP 217 | France |
|
| Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec | Not yet recruiting | Mulhouse | Mulhouse | 68100 | France |
|
| Chirurgie générale et digestive,Hôpital de Hautepierre, | Recruiting | Hôpital de Hautepierre | Strasbourg Cedex | 67098 | France |
|
| CHU Amiens Nord Place Victor Pauchet | Not yet recruiting | Amiens | 80054 | France |
|
| Service de chirurgie digestive Hotel Dieu | Not yet recruiting | Clermont-Ferrand | 63058 | France |
|
| Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers | Not yet recruiting | Colombes | 92700 | France |
|
| chirurgie digestive et générale, Hôpital C Huriez Place de Verdun | Not yet recruiting | Lille | France |
|
| Service de chirurgie digestiveCentre Hospitalier Bretagne Sud | Not yet recruiting | Lorient | 56100 | France |
|
| Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré | Not yet recruiting | Paris | 75475 Paris cedex 10 | France |
|
| Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière | Not yet recruiting | Paris | France |
|
| Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire | Not yet recruiting | Toulouse | France |
|
| Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054 | Not yet recruiting | Toulouse | France |
|
| Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, | Not yet recruiting | Vannes | 56000 | France |
|
| ID | Term |
|---|---|
| D010538 | Peritonitis |
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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