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

NCT01837342 | Unknown DMC

• 1 other identifier: 5061
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 14

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.

Conditions

Peritonitis; Diverticulitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients

  2 years

Study Arms (2)

Sigmoidectomy arm

OTHER

Standard of care arm : sigmoid reserction after randomisation

Procedure: Surgical reserction

Control arm

EXPERIMENTAL

laproscopic drainage and washing

Other: Radiological percutaneous drainage and washing drainage

Interventions

Surgical reserction PROCEDURE

Sigmoidectomy arm

Radiological percutaneous drainage and washing drainage OTHER

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (14)

Chirurgie générale et digestive,Hôpital de Hautepierre,

Strasbourg, Alsace, 67098, France

NOT YET RECRUITING

Clinique Universitaire de Chirurgie Digestive et de l'Urgence

Grenoble, CHU de Grenoble, BP 217, France

NOT YET RECRUITING

Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec

Mulhouse, Mulhouse, 68100, France

NOT YET RECRUITING

Chirurgie générale et digestive,Hôpital de Hautepierre,

Hôpital de Hautepierre, Strasbourg Cedex, 67098, France

RECRUITING

CHU Amiens Nord Place Victor Pauchet

Amiens, 80054, France

NOT YET RECRUITING

Service de chirurgie digestive Hotel Dieu

Clermont-Ferrand, 63058, France

NOT YET RECRUITING

Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers

Colombes, 92700, France

NOT YET RECRUITING

chirurgie digestive et générale, Hôpital C Huriez Place de Verdun

Lille, France

NOT YET RECRUITING

Service de chirurgie digestiveCentre Hospitalier Bretagne Sud

Lorient, 56100, France

NOT YET RECRUITING

Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré

Paris, 75475 Paris cedex 10, France

NOT YET RECRUITING

Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière

Paris, France

NOT YET RECRUITING

Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire

Toulouse, France

NOT YET RECRUITING

Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054

Toulouse, France

NOT YET RECRUITING

Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,

Vannes, 56000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Peritonitis; Diverticulitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases

Study Officials

• 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

  STUDY CHAIR

• 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

Central Study Contacts

Cécile BRIGAND, MD, PHD

CONTACT

03 88 12 72 26; Cecile.brigand@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: April 23, 2013
• Study Start: November 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

FR (14)