PeritonitisSIGMOIDITENCT01837342
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
A study testing Surgical reserction and Radiological percutaneous drainage and washing drainage in people with Peritonitis and Diverticulitis, run by University Hospital, Strasbourg, France at 14 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peritonitis, Diverticulitis
- What is being tested?
- Surgical reserction and Radiological percutaneous drainage and washing drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesFrance
- Study dates
- Nov 2012to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 9Show fewer
- Pregnant and breastfeeding women
- Subjects under tutorship or curator ship
- Subjets under judicial protection
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites, 14 recruiting
- Not yet recruiting
CHU Amiens Nord Place Victor Pauchet
Amiens, 80054
Jean Marc REGIMBEAU, MD
- Not yet recruiting
Service de chirurgie digestive Hotel Dieu
Clermont-Ferrand, 63058
Karim SLIM, MD,PHD
- Not yet recruiting
Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers
Colombes, 92700
Simon MSIKA, MD
- Not yet recruiting
Clinique Universitaire de Chirurgie Digestive et de l'Urgence
Grenoble, CHU de Grenoble, BP 217
Catherine ARVIEUX, MD, PHD, 04 76 76 92 80, carvieux@chu-grenoble.fr
- Recruiting
Chirurgie générale et digestive,Hôpital de Hautepierre,
Hôpital de Hautepierre, Strasbourg Cedex, 67098
BRIGAND Cécile, MD
- Not yet recruiting
chirurgie digestive et générale, Hôpital C Huriez Place de Verdun
Lille
Christophe MARIETTE, MD, PHD
- Not yet recruiting
Service de chirurgie digestiveCentre Hospitalier Bretagne Sud
Lorient, 56100
David GUINIER, MD, 02 97 64 90 00, d.guinier@ch-bretagne-sud.fr
David GUINIER, MD
- Not yet recruiting
Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec
Mulhouse, Mulhouse, 68100
DAN Sébastien, MD, 0389647339, dans@ch-mulhouse.fr
- Not yet recruiting
Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré
Paris, 75475 Paris cedex 10
Marc POCARD, MD
- Not yet recruiting
Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière
Paris
Mehdi KAROUI, MD
David GUINIER, MD
- Not yet recruiting
Chirurgie générale et digestive,Hôpital de Hautepierre,
Strasbourg, Alsace, 67098
Cécile BRIGAND, MD, PDH, 03 88 12 72 26, Cecile.brigand@chru-strasbourg.fr
Cécile Brigand, MD,PHD
- Not yet recruiting
Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire
Toulouse
Bertrand SUC, MD
- Not yet recruiting
Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054
Toulouse
Fabrice MUSCARI, MD
- Not yet recruiting
Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,
Vannes, 56000
Didier RIO, MD
About this study
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.
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.
Read more
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
- Being tested
- Surgical reserction, Radiological percutaneous drainage and washing drainage
- Medical subject headings
- Peritonitis, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical reserctionProcedure or surgery
Radiological percutaneous drainage and washing drainageOther
| Study group | Role | What they receive |
|---|---|---|
| Sigmoidectomy arm | Other | Standard of care arm : sigmoid reserction after randomisation Receives: Procedure: Surgical reserction |
| Control arm | Experimental | laproscopic drainage and washing Receives: Other: Radiological percutaneous drainage and washing drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine ARVIEUX, MD,PHD, Principal investigator, Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217Cécile BRIGAND, MD, PHD, Study chair, Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg CedexSébastien DAN, MD, Principal investigator, Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R LaennecDavid GUINIER, MD, Principal investigator, Service de chirurgie digestive,Centre Hospitalier Bretagne Sud, 56100 LorientMehdi KAROUI, MD, Principal investigator, Chirurgie digestive et hépato-bibliaire, Hôpital Henri Mondor AP-HP,CréteilChristophe MARIETTE, MD,PHD, Principal investigator, chirurgie digestive et générale, Hôpital C Huriez ,Place de Verdun ,59037 Lille CedexMSIKA Simon, MD, Principal investigator, Chirurgie digestive, Hôpital, Louis Mourier APHP, 178 rue des renouillers, 92700 ColombesMUSCARI Fabrice, MD, PHD, Principal investigator, Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean, Poulhes 31054 - TOULOUSE CEDEX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837342
- Sponsor's protocol ID
- 5061
- Acronym
- SIGMOIDITE
- Status last verified
- Apr 2013
- First submitted
- 26 Nov 2012
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01837342
- Acronym / sponsor ID
- SIGMOIDITE / 5061
- Conditions
- Peritonitis, Diverticulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigmoidectomy arm | Other | Procedure: Surgical reserctionStandard of care arm : sigmoid reserction after randomisation |
| Control arm | Experimental | Other: Radiological percutaneous drainage and washing drainagelaproscopic drainage and washing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical reserction | Procedure or surgery | Sigmoidectomy arm |
| Radiological percutaneous drainage and washing drainage | Other | Control arm |
Primary outcome
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
1 secondary outcome
Determeine if the conservative treatment reduces mortaity and ameliorates quality of life diverticulitis patients
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
Related trials for Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Recruiting
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Fecal Peritonitis, Secondary Peritonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine ARVIEUX, MD,PHD principal investigator
Clinique Universitaire de Chirurgie Digestive et de l'Urgence, CHU de Grenoble, BP 217
Cécile BRIGAND, MD, PHD study chair
Chirurgie générale et digestive, Hôpital de Hautepierre, 67098 Strasbourg Cedex
Sébastien DAN, MD principal investigator
Chirurgie Digestive, Centre Hospitalier Emile Muller,20, avenue de Dr R Laennec
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical reserction and Radiological percutaneous drainage and washing drainage in people with Peritonitis and Diverticulitis, run by University Hospital, Strasbourg, France at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile BRIGAND, MD, PHD (03 88 12 72 26, Cecile.brigand@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine which of the two aproaches: the conservative treatment or sigmoid resection reduces morbidity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.