Clinical trial NCT01837342: Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery
Official title: Multicenter Randomized Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peritonitis
Diverticulitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients who have had an episode of sigmoid diverticulitis as a result of pelvic or purulent peritonitis (Hinchey stage II and III) complications and treated by conservative treatment such as per cutaneous radiological drainage or laparoscopic-assisted per cutaneous drainage.
* Male and female individuals aged from 18 to 65 years old (both ages included).
* Absence of contra-indication for surgery ASA Score ≤3
* Participants must have signed informed consent document indicating that they understand the purpose and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
* Patients will sign an informed consent after haven been informed of the results of the previous medical visit.
* Patients must be affiliated with, or a beneficiary of a social security system

Exclusion Criteria:

* Subjects in the exclusion period (haven participated in a previous trial or an ongoing trial )
* Contra- indication to surgery
* ASA Score \>3
* Past history of evolutive neoplasm,
* Subjects unable to consent (case of emergency, subjects having difficulties in understanding)
* Patients for which consultation visits will not be possible (e.g. tourists and people who cannot stay above 18 months in France).
* Pregnant and breastfeeding women
* Subjects under tutorship or curator ship
* Subjets under judicial protection

Primary outcomes:
measure: Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity
timeFrame: 2 years
Secondary outcomes:
measure: Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Chirurgie générale et digestive,Hôpital de Hautepierre,
state: Alsace
city: Grenoble
country: France
facility: Clinique Universitaire de Chirurgie Digestive et de l'Urgence
state: CHU de Grenoble
city: Hôpital de Hautepierre
country: France
facility: Chirurgie générale et digestive,Hôpital de Hautepierre,
state: STRASBOURG cedex
city: Amiens
country: France
facility: CHU Amiens Nord Place Victor Pauchet
city: Clermont ferrand
country: France
facility: Service de chirurgie digestive Hotel Dieu
city: Colombes
country: France
facility: Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers
city: Lille
country: France
facility: chirurgie digestive et générale, Hôpital C Huriez Place de Verdun
city: Lorient
country: France
facility: Service de chirurgie digestiveCentre Hospitalier Bretagne Sud
city: Mulhouse
country: France
facility: Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec
city: Paris
country: France
facility: Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré
city: Paris
country: France
facility: Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière
city: Toulouse
country: France
facility: Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire
city: Toulouse
country: France
facility: Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,
Study officials:
affiliation: Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217
name: Catherine ARVIEUX, MD,PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex
name: Cécile BRIGAND, MD, PHD
role: STUDY_CHAIR
affiliation: Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec
name: Sébastien DAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 Lorient
name: David GUINIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,Créteil
name: Mehdi KAROUI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille Cedex
name: Christophe MARIETTE, MD,PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 Colombes
name: MSIKA Simon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 - TOULOUSE CEDEX
name: MUSCARI Fabrice, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10
name: Marc POCARD, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens Nord Place Victor, Pauchet 80054 Amiens
name: REGIMBEAU Jean Marc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de chirurgie digestive et viscérale, Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, 56000 Vannes
name: Didier RIO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de chirurgie digestive Hotel Dieu, Bd Léon Malfreyt
name: Karim SLIM, MD,PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire de TOULOUSE - RANGUEIL Avenue Jean Poulhes 31054 - TOULOUSE CEDEX
name: Bertrand SUC, MD
role: PRINCIPAL_INVESTIGATOR
References: