Perforated DiverticulitisPhase 3LadiesNCT01317485
Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis
A Phase 3 study testing Laparoscopic lavage and drainage, Sigmoidectomy with primary anastomosis and Sigmoidectomy with end-colostomy in people with Perforated Diverticulitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 41 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Perforated Diverticulitis
- What is being tested?
- Laparoscopic lavage and drainage, Sigmoidectomy with primary anastomosis and Sigmoidectomy with end-colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 41 sitesin 2 countries
- Study dates
- Apr 2010to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- dementia
- prior sigmoidectomy
- steroid treatment > 20 mg daily
- prior pelvic irradiation
- preoperative shock: requirement of inotropics due to circulatory insufficiency
Trial locations and contacts
41 sites in 2 countries.
W.A. Bemelman, Professor contact
J.F. Lange, Professor contact
41 sites in 2 countries
Netherlands39 sites, 39 recruiting
- Recruiting
Jeroen Bosch Hospital
's-Hertogenbosch
H. Prins
- Recruiting
Flevo Hospital
Almere Stad
M. Boom
- Not yet recruiting
Rijnland Hospital
Alphen Aan de Rijn and Leiderdorp
P.A. Neijenhuis
- Recruiting
Meander Medical Centre
Amersfoort
E.C.J. Consten
- Recruiting
Academic Medical Centre
Amsterdam
W.A. Bemelman
- Recruiting
Free University Medical Centre
Amsterdam
D.L. van der Peet
- Recruiting
Onze Lieve Vrouwe Hospital
Amsterdam
M.F. Gerhards
- Recruiting
Slotervaart Hospital
Amsterdam
S.C. Bruin
- Recruiting
St. Lucas Andreas Hospital
Amsterdam
B.A. van Wagensveld
- Recruiting
Alysis Medical Centre
Arnhem
C.F.J.M. Blanken-Peeters
- Recruiting
Rode Kruis Hospital
Beverwijk
H.A. Cense
- Recruiting
Amphia Hospital
Breda
R.M.P.M. Crolla
- Recruiting
IJsselland Hospital
Capelle aan den IJssel
E.J.R. de Graaf
- Recruiting
Reinier de Graaf Hospital
Delft
T.M. Karsten
- Not yet recruiting
Deventer Hospital
Deventer
R.J.I. Bosker
- Recruiting
Albert Schweitzer Hospital
Dordrecht and Zwijndrecht
J.A.B. van der Hoeven
- Recruiting
Gelderse Vallei Hospital
Ede
Ph.M. Kruyt
- Recruiting
Catharina Hospital
Eindhoven
S.W. Nienhuijs
- Recruiting
Medical Spectrum Twente
Enschede
E.B. van Duyn
- Recruiting
Groene Hart Hospital
Gouda
D.J. Swank
- Recruiting
Kennemer Hospital
Haarlem
H.B.A.C. Stockmann
- Recruiting
Atrium Medical Centre
Heerlen and Brunssum
M.N. Sosef
- Recruiting
Tergooi Hospitals
Hilversum and Blaricum
A.A.W. van Geloven
- Recruiting
Spaarne Hospital
Hoofddorp
Q.A.J. Eijsbouts
- Recruiting
Westfries Hospital
Hoorn
M.J.P.M. Govaert
- Not yet recruiting
Leiden University Medical Centre
Leiden
R.A.E.M. Tollenaar
- Recruiting
Maastricht University Medical Centre
Maastricht
L.P.S. Stassen
- Recruiting
St. Antonius Hospital
Nieuwegein
M.J. Wiezer
- Recruiting
Erasmus Medical Centre
Rotterdam
J.F. Lange
- Recruiting
Ikazia Hospital
Rotterdam
W.F. Weidema
- Recruiting
Maasstad Hospital
Rotterdam
P.P.L.O. Coene
- Recruiting
St. Franciscus Hospital
Rotterdam
G.H.H. Mannaerts
- Recruiting
Orbis Medical Centre
Sittard
A.G.M. Hoofwijk
- Recruiting
Haga Hospital
The Hague
W.H. Steup
- Recruiting
Twee Steden Hospital
Tilburg and Waalwijk
J.K. Maring
- Recruiting
University Medical Centre Utrecht
Utrecht
W.M.U. van Grevenstein
- Recruiting
Máxima Medical Centre
Veldhoven
G.D. Slooter
- Recruiting
Zaans Medical Centre
Zaandam
A.F. Engel
- Recruiting
Isala Hospitals
Zwolle
E.G.J.M. Pierik
Belgium2 sites, 2 recruiting
- Not yet recruiting
University Clinic St. Luc
Brussels
A. Kartheuser
C. Remue
- Recruiting
University Hospital Leuven
Leuven
A. d'Hoore
About this study
Official title: Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis: a Nationwide Multicenter Randomised Trial
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.
Read the detailed description
Patients diagnosed as having perforated diverticulitis with free air on plain abdominal X-ray or CT scan fulfilling the in- and exclusion criteria are randomised during laparoscopy via a central computer. In case of purulent diverticulitis patients are randomised to three arms: (a) laparoscopic lavage, (b) sigmoidectomy with colostomy or (c) sigmoidectomy with anastomosis in ratio of 2:1:1. In case of faecal peritonitis or an overt perforation of the sigmoid, the patient will be randomised 1:1 to sigmoidectomy with colostomy or sigmoidectomy with primary anastomosis.
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
- Perforated Diverticulitis
- Being tested
- Laparoscopic lavage and drainage, Sigmoidectomy with primary anastomosis, Sigmoidectomy with end-colostomy
- Keywords
- diverticulitis, perforation, sigmoidectomy, sigmoid resection, lavage, laparoscopic, wash-out, rinsing, hartmann, end-colostomy, primary anastomosis
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic lavage and drainageProcedure or surgery
[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 anastomosisProcedure or surgery
Also called Sigmoid resection
[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-colostomyProcedure or surgery
Also called Hartmann procedure
[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.
| Study group | Role | What they receive |
|---|---|---|
| Purulent peritonitis | Experimental | 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 Receives: Procedure: Laparoscopic lavage and drainage; Procedure: Sigmoidectomy with primary anastomosis; Procedure: Sigmoidectomy with end-colostomy |
| Fecal peritonitis or overt perforation | Experimental | Patients with fecal peritonitis or an overt perforation are randomised between
1. Sigmoidectomy with primary anastomosis
2. Sigmoidectomy with end-colostomy Receives: Procedure: Sigmoidectomy with primary anastomosis; Procedure: Sigmoidectomy with end-colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: One year
Secondary outcomes (7)
Operating time
Measured: - (day 1)
Hospital stay
Measured: - (day one until discharge from hospital)
Number of days alive and outside the hospital
Measured: One year
Incisional hernia
Measured: One year
Reinterventions
All reinterventions within a one year time frame, including percutaneous abscess drainage.
Measured: One year
Health related quality of life
SF-36, EQ-5D, GIQLI measured at 2, 4, 13 and 26 weeks after primary surgery.
Measured: One year
Health care utilisation and associated costs
SF-HLQ measured at 4, 13, 26, 39 and 52 weeks after primary surgery
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perforated DiverticulitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- J.F. Lange, Professor, Principal investigator, Erasmus Medical Centre, RotterdamW.A. Bemelman, Professor, Principal investigator, Academic Medical Centre, Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317485
- Sponsor's protocol ID
- NTR2037
- Acronym
- Ladies
- Status last verified
- Mar 2014
- First submitted
- 16 Mar 2011
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19788490Salem 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.
PubMed 15622591Constantinides 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.
PubMed 16752192Hoek 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.
PubMed 35606544Lambrichts 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.
PubMed 31178342Vennix 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.
PubMed 26209030
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis: a Nationwide Multicenter Randomised Trial
- ClinicalTrials.gov ID
- NCT01317485
- Acronym / sponsor ID
- Ladies / NTR2037
- Conditions
- Perforated Diverticulitis
- Keywords
- diverticulitis, perforation, sigmoidectomy, sigmoid resection, lavage, laparoscopic, wash-out, rinsing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 283 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Apr 2010
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients diagnosed as having perforated diverticulitis with free air on plain abdominal X-ray or CT scan fulfilling the in- and exclusion criteria are randomised during laparoscopy via a central computer. In case of purulent diverticulitis patients are randomised to three arms: (a) laparoscopic lavage, (b) sigmoidectomy with colostomy or (c) sigmoidectomy with anastomosis in ratio of 2:1:1. In case of faecal peritonitis or an overt perforation of the sigmoid, the patient will be randomised 1:1 to sigmoidectomy with colostomy or sigmoidectomy with primary anastomosis.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purulent peritonitis | Experimental | Procedure: Laparoscopic lavage and drainage, Procedure: Sigmoidectomy with primary anastomosis, Procedure: Sigmoidectomy with end-colostomyPatients 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 | Experimental | Procedure: Sigmoidectomy with primary anastomosis, Procedure: Sigmoidectomy with end-colostomyPatients with fecal peritonitis or an overt perforation are randomised between 1. Sigmoidectomy with primary anastomosis 2. Sigmoidectomy with end-colostomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- dementia
- prior sigmoidectomy
- steroid treatment > 20 mg daily
- prior pelvic irradiation
- preoperative shock: requirement of inotropics due to circulatory insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Purulent peritonitis |
| Sigmoidectomy with primary anastomosisAlso: Sigmoid resection[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. | Procedure or surgery | Fecal peritonitis or overt perforation, Purulent peritonitis |
| Sigmoidectomy with end-colostomyAlso: Hartmann procedure[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. | Procedure or surgery | Fecal peritonitis or overt perforation, Purulent peritonitis |
Primary outcome
Mortality and major morbidity (combined)
Time frame: One-year
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.
Stoma-free survival
Time frame: One year
Stoma-free survival one year after initial surgery, is the primary outcome for the comparison of the resectional strategies (DIVA).
7 secondary outcomes
Operating time
Time frame: - (day 1)
Hospital stay
Time frame: - (day one until discharge from hospital)
Number of days alive and outside the hospital
Time frame: One year
Incisional hernia
Time frame: One year
Reinterventions
Time frame: One year
Health related quality of life
Time frame: One year
Health care utilisation and associated costs
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- Background: PubMed 19788490Toorenvliet 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.
- Background: PubMed 15622591Salem 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.
- Background: PubMed 16752192Constantinides 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.
- Derived from this study: PubMed 35606544Hoek 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.
- Derived from this study: PubMed 31178342Lambrichts 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.
- Derived from this study: PubMed 26209030Vennix 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W.A. Bemelman, Professor contact
J.F. Lange, Professor contact
J.F. Lange, Professor principal investigator
Erasmus Medical Centre, Rotterdam
W.A. Bemelman, Professor principal investigator
Academic Medical Centre, Amsterdam
41 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laparoscopic lavage and drainage, Sigmoidectomy with primary anastomosis and Sigmoidectomy with end-colostomy in people with Perforated Diverticulitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 41 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact W.A. Bemelman, Professor (w.a.bemelman@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and major morbidity (combined) (time frame: One-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317485, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.