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 (SIGMOIDITE)

April 17, 2013 updated by: University Hospital, Strasbourg, France

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU Amiens Nord Place Victor Pauchet
        • Principal Investigator:
          • Jean Marc REGIMBEAU, MD
      • Clermont ferrand, France, 63058
        • Not yet recruiting
        • Service de chirurgie digestive Hotel Dieu
        • Principal Investigator:
          • Karim SLIM, MD,PHD
      • Colombes, France, 92700
        • Not yet recruiting
        • Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers
        • Principal Investigator:
          • Simon MSIKA, MD
      • Lille, France
        • Not yet recruiting
        • chirurgie digestive et générale, Hôpital C Huriez Place de Verdun
        • Principal Investigator:
          • Christophe MARIETTE, MD, PHD
      • Lorient, France, 56100
        • Not yet recruiting
        • Service de chirurgie digestiveCentre Hospitalier Bretagne Sud
        • Contact:
        • Principal Investigator:
          • David GUINIER, MD
      • Mulhouse, France, 68100
        • Not yet recruiting
        • Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec
        • Contact:
      • Paris, France, 75475 Paris cedex 10
        • Not yet recruiting
        • Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré
        • Principal Investigator:
          • Marc POCARD, MD
      • Paris, France
        • Not yet recruiting
        • Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière
        • Principal Investigator:
          • David GUINIER, MD
        • Contact:
          • Mehdi KAROUI, MD
      • Toulouse, France
        • Not yet recruiting
        • Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire
        • Principal Investigator:
          • Bertrand SUC, MD
      • Toulouse, France
        • Not yet recruiting
        • Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054
        • Principal Investigator:
          • Fabrice Muscari, MD
      • Vannes, France, 56000
        • Not yet recruiting
        • Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,
        • Principal Investigator:
          • Didier RIO, MD
    • Alsace
      • Strasbourg, Alsace, France, 67098
        • Not yet recruiting
        • Chirurgie générale et digestive,Hôpital de Hautepierre,
        • Contact:
        • Principal Investigator:
          • Cécile Brigand, MD,PHD
    • CHU de Grenoble
      • Grenoble, CHU de Grenoble, France, BP 217
        • Not yet recruiting
        • Clinique Universitaire de Chirurgie Digestive et de l'Urgence
        • Contact:
    • STRASBOURG cedex
      • Hôpital de Hautepierre, STRASBOURG cedex, France, 67098
        • Recruiting
        • Chirurgie générale et digestive,Hôpital de Hautepierre,
        • Principal Investigator:
          • BRIGAND Cécile, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Sigmoidectomy arm
Standard of care arm : sigmoid reserction after randomisation
Procedure: Surgical reserction
Experimental: Control arm
laproscopic drainage and washing
Other: Radiological percutaneous drainage and washing drainage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity
Time Frame: 2 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine ARVIEUX, MD,PHD, Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217
  • Study Chair: Cécile BRIGAND, MD, PHD, Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diverticulitis

Clinical Trials on Surgical reserction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings