Ladies Trial
Dutch/Belgian/Italian multicenter RCT (trialregister.nl NTR2037; ClinicalTrials.gov NCT01317485), part of the Dutch Diverticular Disease Collaborative Study group (alongside DIABOLO and DIRECT trials — neither ingested here). Two arms, both now ingested:
- LOLA — laparoscopic lavage vs. sigmoidectomy, for Hinchey III (purulent peritonitis) only.
- DIVA — Hartmann’s procedure vs. sigmoidectomy with primary anastomosis, for Hinchey III or IV (purulent or faecal peritonitis).
Publications tracked here
| Report | Question | Status in this wiki |
|---|---|---|
| Vennix et al., Lancet 2015 — LOLA group | Lavage vs. resection | Ingested: Vennix 2015 - Ladies Trial LOLA |
| Lambrichts et al., Lancet Gastroenterol Hepatol 2019 — DIVA group | Hartmann’s vs. primary anastomosis | Ingested: Lambrichts 2019 - LADIES DIVA Trial |
Headline results
LOLA (lavage vs. resection): stopped early (90/264 planned patients) after a Data Safety Monitoring Board safety signal — higher reintervention rate in the lavage arm. No significant difference in the 12-month primary composite endpoint (67% lavage vs 60% resection), but short-term major morbidity was significantly higher with lavage (39% vs 19%). Recurrent diverticulitis much higher with lavage (20% vs 2%). See Vennix 2015 - Ladies Trial LOLA.
DIVA (Hartmann’s vs. primary anastomosis): stopped early for slow accrual (not safety). Primary anastomosis strongly favored — 12-month stoma-free survival 94.6% vs 71.7% (HR 2.79, p<0.0001), benefit present and even larger in Hinchey IV than Hinchey III. No difference in short-term morbidity/mortality after the index procedure; post-reversal morbidity notably lower with primary anastomosis (8% vs 30%). See Lambrichts 2019 - LADIES DIVA Trial — one of the more decisive, less contested findings in this wiki so far.
Relation to other trials
See SCANDIV Trial for a cross-trial comparison on the lavage-vs-resection question — the recurrence signal replicates closely between Ladies (LOLA) and SCANDIV, but Ladies showed a starker short-term morbidity/reintervention signal (severe enough to stop the trial early), which SCANDIV’s 5-year report did not reproduce. DILALA and LapLAND are two further RCTs on the lavage-vs-resection question, referenced in both trials’ discussions but not yet ingested here. No other ingested trial yet addresses the Hartmann’s-vs-primary-anastomosis question that DIVA answers.