Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis
Ladies
1 other identifier
interventional
283
2 countries
41
Brief Summary
The first objective (LOLA) of this integrated trial is to determine whether laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy in patients with perforated diverticulitis with purulent peritonitis in terms of mortality and major morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with anastomosis or sigmoidectomy with end-colostomy is the superior approach in patients with perforated diverticulitis with either purulent or faecal peritonitis in terms of stoma free survival. The study is designed as a multicenter and randomised trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2010
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 21, 2014
March 1, 2014
6.9 years
March 16, 2011
March 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mortality and major morbidity (combined)
The primary outcome in the lavage vs. resectional intervention comparison (LOLA), will be poor clinical outcome, defined as a combined endpoint consisting of mortality and major morbidity one year after initial surgery. Major morbidity includes any of the following events or conditions: reintervention, wound dehiscence, incisional hernia, abscess needing percutaneous drainage, urosepsis, myocardial infarction, renal failure and respiratory insufficiency.
One-year
Stoma-free survival
Stoma-free survival one year after initial surgery, is the primary outcome for the comparison of the resectional strategies (DIVA).
One year
Secondary Outcomes (7)
Operating time
- (day 1)
Hospital stay
- (day one until discharge from hospital)
Number of days alive and outside the hospital
One year
Incisional hernia
One year
Reinterventions
One year
- +2 more secondary outcomes
Study Arms (2)
Purulent peritonitis
EXPERIMENTALPatients with purulent peritonitis are randomised at a 2:1:1 ratio between 1. Laparoscopic lavage and drainage 2. Sigmoidectomy with primary anastomosis 3. Sigmoidectomy with end-colostomy
Fecal peritonitis or overt perforation
EXPERIMENTALPatients with fecal peritonitis or an overt perforation are randomised between 1. Sigmoidectomy with primary anastomosis 2. Sigmoidectomy with end-colostomy
Interventions
\[CLOSED\] The abdominal cavity is irrigated with six litres of warm saline in all four quadrants. At the end of the procedure a Douglas drain is inserted via the right lateral port. \*\*\*This part of the study was closed in 2013 on advice of the data and safety monitoring board due to safety issues
\[OPEN\] Sigmoidectomy is done according to the guidelines of the American Society of Colon and Rectal Surgeons. The distal transsection margin has to be on the proximal rectum, the proximal margin is determined by the absence of wall thickening due to diverticulitis. The type of anastomosis is done according to the preference of the operating surgeon. A loop ileostomy can be fashioned in order to ensure faecal deviation to the discretion of the surgeon.
\[OPEN\] This is a two-stage procedure with the intention to close the colostomy in a second stage. During the primary surgery, only the perforated diseased part must be resected. There is no need of having the distal transsection line on the proximal rectum.
Eligibility Criteria
You may qualify if:
- patients suspected of diverticulitis
- age in between 18 and 85 years old
- with written informed consent
- with free air on plain abdominal or thoracic X-ray or CT-scan OR with peritonitis and diffuse gas or fluid on CT-scan
You may not qualify if:
- dementia
- prior sigmoidectomy
- steroid treatment \> 20 mg daily
- prior pelvic irradiation
- preoperative shock: requirement of inotropics due to circulatory insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University Clinic St. Luc
Brussels, Belgium
University Hospital Leuven
Leuven, Belgium
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Flevo Hospital
Almere Stad, Netherlands
Rijnland Hospital
Alphen Aan de Rijn and Leiderdorp, Netherlands
Meander Medical Centre
Amersfoort, Netherlands
Academic Medical Centre
Amsterdam, Netherlands
Free University Medical Centre
Amsterdam, Netherlands
Onze Lieve Vrouwe Hospital
Amsterdam, Netherlands
Slotervaart Hospital
Amsterdam, Netherlands
St. Lucas Andreas Hospital
Amsterdam, Netherlands
Alysis Medical Centre
Arnhem, Netherlands
Rode Kruis Hospital
Beverwijk, Netherlands
Amphia Hospital
Breda, Netherlands
IJsselland Hospital
Capelle aan den IJssel, Netherlands
Reinier de Graaf Hospital
Delft, Netherlands
Deventer Hospital
Deventer, Netherlands
Albert Schweitzer Hospital
Dordrecht and Zwijndrecht, Netherlands
Gelderse Vallei Hospital
Ede, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Medical Spectrum Twente
Enschede, Netherlands
Groene Hart Hospital
Gouda, Netherlands
Kennemer Hospital
Haarlem, Netherlands
Atrium Medical Centre
Heerlen and Brunssum, Netherlands
Tergooi Hospitals
Hilversum and Blaricum, Netherlands
Spaarne Hospital
Hoofddorp, Netherlands
Westfries Hospital
Hoorn, Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
Ikazia Hospital
Rotterdam, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
St. Franciscus Hospital
Rotterdam, Netherlands
Orbis Medical Centre
Sittard, Netherlands
Haga Hospital
The Hague, Netherlands
Twee Steden Hospital
Tilburg and Waalwijk, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
Máxima Medical Centre
Veldhoven, Netherlands
Zaans Medical Centre
Zaandam, Netherlands
Isala Hospitals
Zwolle, Netherlands
Related Publications (6)
Toorenvliet BR, Swank H, Schoones JW, Hamming JF, Bemelman WA. Laparoscopic peritoneal lavage for perforated colonic diverticulitis: a systematic review. Colorectal Dis. 2010 Sep;12(9):862-7. doi: 10.1111/j.1463-1318.2009.02052.x. Epub 2009 Sep 26.
PMID: 19788490BACKGROUNDSalem L, Flum DR. Primary anastomosis or Hartmann's procedure for patients with diverticular peritonitis? A systematic review. Dis Colon Rectum. 2004 Nov;47(11):1953-64. doi: 10.1007/s10350-004-0701-1.
PMID: 15622591BACKGROUNDConstantinides VA, Tekkis PP, Athanasiou T, Aziz O, Purkayastha S, Remzi FH, Fazio VW, Aydin N, Darzi A, Senapati A. Primary resection with anastomosis vs. Hartmann's procedure in nonelective surgery for acute colonic diverticulitis: a systematic review. Dis Colon Rectum. 2006 Jul;49(7):966-81. doi: 10.1007/s10350-006-0547-9.
PMID: 16752192BACKGROUNDHoek VT, Edomskis PP, Stark PW, Lambrichts DPV, Draaisma WA, Consten ECJ, Lange JF, Bemelman WA; LADIES trial collaborators. Laparoscopic peritoneal lavage versus sigmoidectomy for perforated diverticulitis with purulent peritonitis: three-year follow-up of the randomised LOLA trial. Surg Endosc. 2022 Oct;36(10):7764-7774. doi: 10.1007/s00464-022-09326-3. Epub 2022 May 23.
PMID: 35606544DERIVEDLambrichts DPV, Vennix S, Musters GD, Mulder IM, Swank HA, Hoofwijk AGM, Belgers EHJ, Stockmann HBAC, Eijsbouts QAJ, Gerhards MF, van Wagensveld BA, van Geloven AAW, Crolla RMPH, Nienhuijs SW, Govaert MJPM, di Saverio S, D'Hoore AJL, Consten ECJ, van Grevenstein WMU, Pierik REGJM, Kruyt PM, van der Hoeven JAB, Steup WH, Catena F, Konsten JLM, Vermeulen J, van Dieren S, Bemelman WA, Lange JF; LADIES trial collaborators. Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or faecal peritonitis (LADIES): a multicentre, parallel-group, randomised, open-label, superiority trial. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):599-610. doi: 10.1016/S2468-1253(19)30174-8. Epub 2019 Jun 6.
PMID: 31178342DERIVEDVennix S, Musters GD, Mulder IM, Swank HA, Consten EC, Belgers EH, van Geloven AA, Gerhards MF, Govaert MJ, van Grevenstein WM, Hoofwijk AG, Kruyt PM, Nienhuijs SW, Boermeester MA, Vermeulen J, van Dieren S, Lange JF, Bemelman WA; Ladies trial colloborators. Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial. Lancet. 2015 Sep 26;386(10000):1269-1277. doi: 10.1016/S0140-6736(15)61168-0. Epub 2015 Jul 22.
PMID: 26209030DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J.F. Lange, Professor
Erasmus Medical Centre, Rotterdam
- PRINCIPAL INVESTIGATOR
W.A. Bemelman, Professor
Academic Medical Centre, Amsterdam
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 17, 2011
Study Start
April 1, 2010
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 21, 2014
Record last verified: 2014-03