Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis
NCT ID: NCT01317485
Last Updated: 2014-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
283 participants
INTERVENTIONAL
2010-04-30
2017-03-31
Brief Summary
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Detailed Description
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The first primary outcome parameter consists of a combined endpoint consisting of mortality and major morbidity (LOLA). The second primary endpoint consists of stoma-free survival one year after initial surgery (DIVA). Secondary endpoints are number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. A sample size of 132:66:66 patients per treatment arm will be able to detect a difference in the combined endpoint of serious complications and mortality from 25% in the two sigmoidectomy groups compared to 10% in the lavage group (two-side alpha of 5% and a power of 90%. In the DIVA analysis 2x132 patients are needed to significantly demonstrate a difference of 30% in stoma-free survival between both treatment arms (log rank test two-sided alpha of 5% and power of 90%) in favour of the patients with primary anastomosis. More than 35 hospitals will participate in this study with an estimated total inclusion of 100 patients per year. Patients will be followed for one year.
The study will be executed in concordance with the protocol, the Good Clinical Practice guidelines and regulatory requirements.
After closure of the LOLA-arm due to safety concerns for laparoscopic lavage, the protocol and sample size has for the DIVA-arm been adjusted to 118 patients per study arm (faecal or purulent peritonitis).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Purulent peritonitis
Patients 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
Laparoscopic lavage and drainage
\[CLOSED\] 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
Sigmoidectomy with primary anastomosis
\[OPEN\] 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.
Sigmoidectomy with end-colostomy
\[OPEN\] 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.
Fecal peritonitis or overt perforation
Patients with fecal peritonitis or an overt perforation are randomised between
1. Sigmoidectomy with primary anastomosis
2. Sigmoidectomy with end-colostomy
Sigmoidectomy with primary anastomosis
\[OPEN\] 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.
Sigmoidectomy with end-colostomy
\[OPEN\] 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.
Interventions
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Laparoscopic lavage and drainage
\[CLOSED\] 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
Sigmoidectomy with primary anastomosis
\[OPEN\] 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.
Sigmoidectomy with end-colostomy
\[OPEN\] 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* prior sigmoidectomy
* steroid treatment \> 20 mg daily
* prior pelvic irradiation
* preoperative shock: requirement of inotropics due to circulatory insufficiency
18 Years
85 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Academic Medical Centre Amsterdam / Erasmus Medical Centre Rotterdam
Principal Investigators
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J.F. Lange, Professor
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Centre, Rotterdam
W.A. Bemelman, Professor
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Centre, Amsterdam
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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A. Kartheuser
Role: primary
A. d'Hoore
Role: primary
H. Prins
Role: primary
M. Boom
Role: primary
P.A. Neijenhuis
Role: primary
E.C.J. Consten
Role: primary
W.A. Bemelman
Role: primary
D.L. van der Peet
Role: primary
M.F. Gerhards
Role: primary
S.C. Bruin
Role: primary
B.A. van Wagensveld
Role: primary
C.F.J.M. Blanken-Peeters
Role: primary
H.A. Cense
Role: primary
R.M.P.M. Crolla
Role: primary
E.J.R. de Graaf
Role: primary
T.M. Karsten
Role: primary
R.J.I. Bosker
Role: primary
J.A.B. van der Hoeven
Role: primary
Ph.M. Kruyt
Role: primary
S.W. Nienhuijs
Role: primary
E.B. van Duyn
Role: primary
D.J. Swank
Role: primary
H.B.A.C. Stockmann
Role: primary
M.N. Sosef
Role: primary
A.A.W. van Geloven
Role: primary
Q.A.J. Eijsbouts
Role: primary
M.J.P.M. Govaert
Role: primary
R.A.E.M. Tollenaar
Role: primary
L.P.S. Stassen
Role: primary
M.J. Wiezer
Role: primary
J.F. Lange
Role: primary
W.F. Weidema
Role: primary
P.P.L.O. Coene
Role: primary
G.H.H. Mannaerts
Role: primary
A.G.M. Hoofwijk
Role: primary
W.H. Steup
Role: primary
J.K. Maring
Role: primary
W.M.U. van Grevenstein
Role: primary
G.D. Slooter
Role: primary
A.F. Engel
Role: primary
E.G.J.M. Pierik
Role: primary
References
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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.
Salem 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.
Constantinides 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.
Hoek 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.
Lambrichts 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.
Vennix 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.
Related Links
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Related Info
Other Identifiers
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NTR2037
Identifier Type: -
Identifier Source: org_study_id
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