Clinical trial NCT02174926: LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
Official title: LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diverticulum
Colon, Sigmoid
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Gastrointestinal quality of life-index change at 6 months
timeFrame: 6 months from randomization
Secondary outcomes:
measure: GIQLI at 12, 24, 48, and 96 months
timeFrame: 12, 24, 48, and 96 months from randomization
measure: Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months
timeFrame: 6, 12, 24, 48, and 96 months from randomization
measure: Recurrence and severity of recurrent diverticulitis
timeFrame: 0 - 96 months from randomization
measure: Need of emergency surgery due to diverticulitis
timeFrame: 0 - 96 months from randomization
measure: Need of elective sigmoid resection due to diverticulitis (conservative arm)
timeFrame: 0 - 96 months from randomization
measure: Complications due to elective sigmoid resection
timeFrame: 0 - 96 months from randomization
measure: Mortality
timeFrame: 0 - 96 months
measure: Complications of diverticular disease
timeFrame: 0 - 96 months
measure: Stoma rate
timeFrame: 0 - 96 months from randomization
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Central Hospital, Jorvi Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Hämeenlinna
country: Finland
facility: Kanta-Häme Central Hospital
city: Joensuu
country: Finland
facility: North Carelia Central Hospital
city: Jyväskylä
country: Finland
facility: Keski-Suomi Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Central Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Etelä-Pohjanmaa Central Hospital
city: Turku
country: Finland
facility: Turku University Central Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Sallinen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lahdesmaki A, Scheinin T, Sallinen V. Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis: The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):129-136. doi: 10.1001/jamasurg.2020.5151.