No registrations found.
ID
Source
Brief title
Health condition
Diverticulitis, Diverticular disease, Divertikelziekte, Divertikels, Hartmann, Hartmann's procedure, Primary anastomosis, Primaire anastomose, Laparoscopic lavage, Laparoscopische lavage, Hinchey III, Hinchey IV, Purulent peritonitis, Faecal peritonitis, Purulente peritonitis, Faecale peritonitis
Sponsors and support
Initiator: Prof. Dr. W.A. Bemelman
Erasmus Medical Center, Rotterdam,
Initiator: Prof. Dr. J.F Lange
Intervention
Outcome measures
Primary outcome
1. (LOLA-arm) 1 year combined endpoint of major morbidity and mortality for patients randomised between laparoscopic lavage or open resection;
2. (DIVA-arm) 1 year stoma free survival for patients randomised between Hartmann's procedure or sigmoidresection with primary anastomosis.
Secondary outcome
1. Operating time;
2. Hospital Stay;
3. Number of days alive and outside the hospital;
4. Incisional hernia rate;
5. Number of reinterventions;
6. Quality of Life;
7. Cost-effectiveness.
Background summary
This nationwide, multicenter, randomised trial aims to prove the safety and effectiveness of laparoscopic lavage as a treatment for generalised purulent peritonitis for perforated diverticulitis. Secondly, this study wants to prove that sigmoidresection with primary anastomosis with or without protetective loop-ileostomy is the favored option for patients with generalised peritonitis for perforated diverticulitis, since this leads to a higher stoma-free survival.
Study objective
Laparoscopic lavage for purulent peritonitis for perforated diverticulitis leads to a 15% reduction in the combined endpoint of major morbidity and mortality, compared to resection. Resection with primary anastomosis
leads to a 22% reduction in the 1 year stoma-free survival in patients with either purulent or faecal peritonitis for perforated diverticulitis, compared to the Hartmann's procedure.
Study design
Follow-up to all patients is 12 months.
Intervention
All included patients are examined by laparoscopy. Patients with purulent peritonitis are randomised between laparoscopic lavage, open sigmoidresection with primary anastomosis with or without protective loop-ileostomy and Hartmann's procedure in ratio 2:1:1. This group is followed over the course of a year to determine the combined endpoint of mortality and major morbidity.
Patients with faecal peritonitis are randomised between the sigmoidresection with primary anastomosis with or without protective loop-ileostomy and Hartmann's procedure in ration 1:1. This group is followed over the course of a year to determine the stoma-free survival.
Postbus 22660
H.A. Swank
Heelkunde G4-144
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+31 205664580
h.a.swank@amc.uva.nl
Postbus 22660
H.A. Swank
Heelkunde G4-144
Postbus 22660
Amsterdam 1100 DD
The Netherlands
+31 205664580
h.a.swank@amc.uva.nl
Inclusion criteria
1. Clinical suspicion for perforated diverticulitis;
2. Free abdominal gas on CT-scan or plain abdominal X-ray OR peritonitis with diffuse gas or fluid on CT-scan;
3. Patient between 18-85 years;
4. Informed Consent.
Exclusion criteria
1. Prior Sigmoidresection;
2. Dementia;
3. Shock: requirement of inotropics for circulatory stabilisation;
4. Steroid treatment >20mg/day;
5. Pelvic irradiation.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1920 |
| NTR-old | NTR2037 |
| Other | ZonMW : 80-82310-97-10036 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |