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Laparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial (The Ladies Trial).


- candidate number6537
- NTR NumberNTR2037
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2009
- Secondary IDs80-82310-97-10036 ZonMW
- Public TitleLaparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial (The Ladies Trial).
- Scientific TitleLaparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial (The Ladies Trial).
- ACRONYMThe Ladies Trial
- hypothesisLaparoscopic 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.
- Healt Condition(s) or Problem(s) studiedDiverticulitis, Hartmann's procedure, Primary anastomosis, Laparoscopic lavage, Hinchey III, Purulent peritonitis, Faecal peritonitis
- Inclusion criteria1. 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 criteria1. Prior Sigmoidresection;
2. Dementia;
3. Shock: requirement of inotropics for circulatory stabilisation;
4. Steroid treatment >20mg/day;
5. Pelvic irradiation.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate31-dec-2013
- Target number of participants396
- InterventionsAll 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.
- Primary outcome1. 1 year combined endpoint of major morbidity and mortality for patients randomised between laparoscopic lavage or open resection;
2. 1 year stoma free survival for patients randomised between Hartmann's procedure or sigmoidresection with primary anastomosis.
- Secondary outcome1. 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.
- TimepointsFollow-up to all patients is 12 months.
- Trial web sitewww.diverticulitis.nl, www.ladies-trial.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES H.A. Swank
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.A. Bemelman
- Sponsor/Initiator Academic Medical Center (AMC), Department of Surgery, Erasmus Medical Center, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsSwank HA, Vermeulen J, Lange JF, et al. The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037). BMC Surg 2010; 10: 29. (Studie protocol)
- Brief summaryThis 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.
- Main changes (audit trail)2-2-14:
- Planned closing date: 01-03-2017
- Target number of participants: 283 - 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.

Status: 1. LOLA-arm: closed
2. DIVA-arm: open, patient inclusion
- RECORD29-sep-2009 - 2-feb-2014


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