An interventional study of Elective laparoscopic sigmoid resection and Conservative treatment in Diverticulum and Colon, Sigmoid, sponsored by Helsinki University Central Hospital. Active, not recruiting at 11 sites in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to find out whether elective sigmoid resection will improve quality of life compared to conservative treatment with lifestyle guidance and fiber supplement in patients with a recurrent or complicated diverticulitis.
22 studies on the registry are indexed under Diverticulum; 3 are open to participants now.
This study's planned enrollment of 133 is close to the median of 131 across 16 interventional studies indexed under Diverticulum.
Browse Diverticulum studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
OR
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Written lifestyle guidance and fiber supplements
Dietary Supplement: Conservative treatment
Procedure: Elective laparoscopic sigmoid resection
Written lifestyle guidance and fiber supplements
Gastrointestinal quality of life-index change at 6 months
Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.
Time frame: 6 months from randomization
GIQLI at 12, 24, 48, and 96 months
Time frame: 12, 24, 48, and 96 months from randomization
Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months
Time frame: 6, 12, 24, 48, and 96 months from randomization
Recurrence and severity of recurrent diverticulitis
Time frame: 0 - 96 months from randomization
Need of emergency surgery due to diverticulitis
Whether or not patient has undergone emergency surgery due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.
Time frame: 0 - 96 months from randomization
Need of elective sigmoid resection due to diverticulitis (conservative arm)
Whether or not patient has undergone elective sigmoid resection due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.
Time frame: 0 - 96 months from randomization
Complications due to elective sigmoid resection
Time frame: 0 - 96 months from randomization
Mortality
Time frame: 0 - 96 months
Complications of diverticular disease
Time frame: 0 - 96 months
Stoma rate
Time frame: 0 - 96 months from randomization
This study is active, not recruiting, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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