N/A
N=66
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
Acute Diverticulitis
Bottom Line
View on ClinicalTrials.gov: NCT03008707 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Short-term Morbidity — 8; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Laparoscopic Peritoneal Lavage (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-term Morbidity |
8; 1 | — |
| PRIMARY Short-term Mortality |
0; 0 | — |
| PRIMARY Optimal Sepsis Control |
19; 37 | — |
| PRIMARY Post-operative Re-interventions Rate |
5; 0 | — |
| SECONDARY Mean Postoperative Time |
76.74; 225.36 | — |
| SECONDARY Average Length of Postoperative Hospital Stay |
11.4; 8.23 | — |
| SECONDARY Recurrent Colonic Diverticulitis Rate |
6; 0 | — |
| SECONDARY Incisional Hernia Rate |
2; 9 | — |
Summary
Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD) (Modified Hinchey's classification grade II non-responder to conservative therapy and grade III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give better results in patients with CAD
Eligibility Criteria
Inclusion Criteria
- Acute abdominal pain,
- Signs of localized or diffuse peritonitis
- Signs of suspected perforated diverticulitis (diagnostic imaging)
- Signed informed consent
Exclusion Criteria
- Septic shock
- Immunodepression
- Previous multiple abdominal surgical operations
- Modified Hinchey's grade IV
Data sourced from ClinicalTrials.gov (NCT03008707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.