LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial

Colon, Sigmoid Clinical Trial

— LASER  

Official title:

LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02174926
• Other study ID #: LASERtrial
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2027

Study information

• Verified date: August 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: December 2027
• Est. primary completion date: April 2019
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Recurrent left colon diverticulitis (minimum 3 within 2 years, at least 1 confirmed with CT)

OR

• Earlier complicated left colon diverticulitis

OR

• Prolonged (over 3 months) pain or disturbance in bowel habits after a CT-confirmed left colon diverticulitis

Exclusion Criteria:

• Multimorbidity that prevents elective surgery

• Contraindication to laparoscopy

• Colonic stricture

• Fistula (e.g. colocutaneous, colovaginal, colovesical)

• Active malignancy

• Earlier resection of sigmoid colon or rectum

• Acute diverticulitis that has not settled

• Colonoscopy/sigmoidoscopy/virtual colonoscopy not performed within 2 years

• Age < 18 or > 75 years

• Pregnancy

• Inability to answer health surveys (e.g. dementia, psychiatric condition)

Related Conditions & MeSH terms

• Colon, Sigmoid
• Diverticulitis
• Diverticulum

Intervention

Procedure:
• Elective laparoscopic sigmoid resection

Dietary Supplement:
• Conservative treatment
Written lifestyle guidance and fiber supplements

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Jorvi Hospital	Espoo
Finland	Kanta-Häme Central Hospital	Hämeenlinna
Finland	Helsinki University Central Hospital	Helsinki
Finland	North Carelia Central Hospital	Joensuu
Finland	Keski-Suomi Central Hospital	Jyväskylä
Finland	Kuopio University Central Hospital	Kuopio
Finland	Päijät-Häme Central Hospital	Lahti
Finland	Oulu University Hospital	Oulu
Finland	Etelä-Pohjanmaa Central Hospital	Seinäjoki
Finland	Turku University Central Hospital	Turku
Finland	Vaasa Central Hospital	Vaasa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal quality of life-index change at 6 months	Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.	6 months from randomization
Secondary	GIQLI at 12, 24, 48, and 96 months		12, 24, 48, and 96 months from randomization
Secondary	Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months		6, 12, 24, 48, and 96 months from randomization
Secondary	Recurrence and severity of recurrent diverticulitis		0 - 96 months from randomization
Secondary	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.	0 - 96 months from randomization
Secondary	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.	0 - 96 months from randomization
Secondary	Complications due to elective sigmoid resection		0 - 96 months from randomization
Secondary	Mortality		0 - 96 months
Secondary	Complications of diverticular disease		0 - 96 months
Secondary	Stoma rate		0 - 96 months from randomization