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)
Primary Purpose
Peritonitis, Diverticulitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgical reserction
Radiological percutaneous drainage and washing drainage
Sponsored by
About this trial
This is an interventional treatment trial for Peritonitis
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
Sites / Locations
- Chirurgie générale et digestive,Hôpital de Hautepierre,
- Clinique Universitaire de Chirurgie Digestive et de l'Urgence
- Chirurgie générale et digestive,Hôpital de Hautepierre,Recruiting
- CHU Amiens Nord Place Victor Pauchet
- Service de chirurgie digestive Hotel Dieu
- Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers
- chirurgie digestive et générale, Hôpital C Huriez Place de Verdun
- Service de chirurgie digestiveCentre Hospitalier Bretagne Sud
- Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec
- Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré
- Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière
- Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire
- Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054
- Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Sigmoidectomy arm
Control arm
Arm Description
Standard of care arm : sigmoid reserction after randomisation
laproscopic drainage and washing
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01837342
First Posted
November 26, 2012
Last Updated
April 17, 2013
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01837342
Brief Title
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
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Diverticulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sigmoidectomy arm
Arm Type
Other
Arm Description
Standard of care arm : sigmoid reserction after randomisation
Arm Title
Control arm
Arm Type
Experimental
Arm Description
laproscopic drainage and washing
Intervention Type
Procedure
Intervention Name(s)
Surgical reserction
Intervention Type
Other
Intervention Name(s)
Radiological percutaneous drainage and washing drainage
Primary Outcome Measure Information:
Title
Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients
Description
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)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile BRIGAND, MD, PHD
Phone
03 88 12 72 26
Email
Cecile.brigand@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine ARVIEUX, MD,PHD
Organizational Affiliation
Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cécile BRIGAND, MD, PHD
Organizational Affiliation
Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sébastien DAN, MD
Organizational Affiliation
Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David GUINIER, MD
Organizational Affiliation
Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 Lorient
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehdi KAROUI, MD
Organizational Affiliation
Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,Créteil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christophe MARIETTE, MD,PHD
Organizational Affiliation
chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille Cedex
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MSIKA Simon, MD
Organizational Affiliation
Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 Colombes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MUSCARI Fabrice, MD, PHD
Organizational Affiliation
Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 - TOULOUSE CEDEX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc POCARD, MD, PHD
Organizational Affiliation
Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré, 75475 Paris cedex 10
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
REGIMBEAU Jean Marc, MD
Organizational Affiliation
CHU Amiens Nord Place Victor, Pauchet 80054 Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier RIO, MD
Organizational Affiliation
Service de chirurgie digestive et viscérale, Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot, 56000 Vannes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karim SLIM, MD,PHD
Organizational Affiliation
Service de chirurgie digestive Hotel Dieu, Bd Léon Malfreyt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertrand SUC, MD
Organizational Affiliation
Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire de TOULOUSE - RANGUEIL Avenue Jean Poulhes 31054 - TOULOUSE CEDEX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chirurgie générale et digestive,Hôpital de Hautepierre,
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67098
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile BRIGAND, MD, PDH
Phone
03 88 12 72 26
Email
Cecile.brigand@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Cécile Brigand, MD,PHD
Facility Name
Clinique Universitaire de Chirurgie Digestive et de l'Urgence
City
Grenoble
State/Province
CHU de Grenoble
ZIP/Postal Code
BP 217
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine ARVIEUX, MD, PHD
Phone
04 76 76 92 80
Email
carvieux@chu-grenoble.fr
Facility Name
Chirurgie générale et digestive,Hôpital de Hautepierre,
City
Hôpital de Hautepierre
State/Province
STRASBOURG cedex
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BRIGAND Cécile, MD
Facility Name
CHU Amiens Nord Place Victor Pauchet
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Marc REGIMBEAU, MD
Facility Name
Service de chirurgie digestive Hotel Dieu
City
Clermont ferrand
ZIP/Postal Code
63058
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim SLIM, MD,PHD
Facility Name
Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers
City
Colombes
ZIP/Postal Code
92700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon MSIKA, MD
Facility Name
chirurgie digestive et générale, Hôpital C Huriez Place de Verdun
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe MARIETTE, MD, PHD
Facility Name
Service de chirurgie digestiveCentre Hospitalier Bretagne Sud
City
Lorient
ZIP/Postal Code
56100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David GUINIER, MD
Phone
02 97 64 90 00
Email
d.guinier@ch-bretagne-sud.fr
First Name & Middle Initial & Last Name & Degree
David GUINIER, MD
Facility Name
Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DAN Sébastien, MD
Phone
0389647339
Email
dans@ch-mulhouse.fr
Facility Name
Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré
City
Paris
ZIP/Postal Code
75475 Paris cedex 10
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc POCARD, MD
Facility Name
Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi KAROUI, MD
First Name & Middle Initial & Last Name & Degree
David GUINIER, MD
Facility Name
Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand SUC, MD
Facility Name
Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice MUSCARI, MD
Facility Name
Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,
City
Vannes
ZIP/Postal Code
56000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier RIO, MD
12. IPD Sharing Statement
Learn more about this trial
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
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