Status:
UNKNOWN
Quality of Life (QOL) After Elective Sigmoidectomy for Diverticular Diseases (DIVERTI)
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Association Francaise de Chirurgie
Conditions:
Diverticular Disease of Left Side of Colon
Eligibility:
All Genders
18-70 years
Brief Summary
Acute diverticulitis of the left colon is among the most common abdominal disorders. To date, both conservative therapy in uncomplicated stages and emergency surgery in perforated disease with periton...
Detailed Description
Design The DIVERTI-QOL study is a prospective, multicentre, and observational study. The study will start in February 2021. Recruitment will be completed in July 2021. Overall, the inclusion of 110 pa...
Eligibility Criteria
Inclusion
- inclusion criteria:
- Patient who has received informed information and has not expressed opposition to participation
- Francophone patient
- Patient affiliated to a social security or equivalent system
- Patient taken in charge for :
- smoldering DS after DS Hinchey I
- persistence of symptoms after DS complicated by a peri-sigmoid abscess \<1cm with resolution of inflammation
- DS complicated with an abscess \>1cm (Hinchey II)
- Recurrent episodes of DS
- DS in a patient requiring long-term immunosuppressive therapy (except for neoplastic disease undergoing treatment)
- Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis (surgical experimental group) or patient not operated and medically treated (medical control group)
- Exclusion Criteria:
- Subjects meeting only one of the following non-inclusion criteria may not be eligible to participate in the research:
- Patient who is a minor or over 70 years of age
- Patient undergoing emergency surgery for sigmoid diverticulitis due to a complication (peritonitis, hemorrhage, failure of drainage diverticular abscess)
- diverticulitis complicated by fistula and/or symptomatic stenosis
- Colorectal resection protected by an ostomy or Hartmann's intervention
- Discovery of colorectal cancer on the operating room
- Patient operated on for diverticulitis of the right colon
- Neoplastic disease under treatment and/or evolving
Exclusion
Key Trial Info
Start Date :
September 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04730765
Start Date
September 15 2021
End Date
September 30 2022
Last Update
August 31 2021
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