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

Diverticulitis Clinical Trial

— SIGMOIDITE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01837342
• Other study ID #: 5061
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2012
• Last updated: April 17, 2013
• Start date: November 2012
• Est. completion date: November 2017

Study information

• Verified date: April 2013
• Source: University Hospital, Strasbourg, France
• Contact: Cécile BRIGAND, MD, PHD
• Phone: 03 88 12 72 26
• Email: Cecile.brigand[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis
• Peritonitis

Intervention

Procedure:
• Surgical reserction

Other:
• Radiological percutaneous drainage and washing drainage

Locations

Country	Name	City	State
France	CHU Amiens Nord Place Victor Pauchet	Amiens
France	Service de chirurgie digestive Hotel Dieu	Clermont ferrand
France	Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers	Colombes
France	Clinique Universitaire de Chirurgie Digestive et de l'Urgence	Grenoble	CHU de Grenoble
France	Chirurgie générale et digestive,Hôpital de Hautepierre,	Hôpital de Hautepierre	STRASBOURG cedex
France	chirurgie digestive et générale, Hôpital C Huriez Place de Verdun	Lille
France	Service de chirurgie digestiveCentre Hospitalier Bretagne Sud	Lorient
France	Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec	Mulhouse
France	Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière	Paris
France	Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré	Paris
France	Chirurgie générale et digestive,Hôpital de Hautepierre,	Strasbourg	Alsace
France	Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire	Toulouse
France	Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054	Toulouse
France	Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No