Clinical trial NCT03008707: Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)
Official title: Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Diverticulitis
Keywords: Laparoscopic peritoneal lavage
laparoscopic sigmoidectomy
complicated acute diverticulitis
D004238
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
Collaborators: name: Ospedale San Jacopo, Pistoia
name: S. Andrea Hospital
name: Maggiore Bellaria Hospital, Bologna
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: A.O. Ospedale Papa Giovanni XXIII
name: Hospitales Universitarios Virgen del Rocío
name: George Papanicolaou Hospital
First posted: 2017-01-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complicated acute diverticulitis

Brief 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

Detailed description: In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage in the management of complicated acute diverticulitis. Recently, three important prospective randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions, as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in the short-term. To our knowledge, no international guidelines promote the use of LPL in complicated acute diverticulitis. We believe this technique could be safely used in a selected cohort of patients and, in some circumstances, could represent a "bridge" to a possible planned resection. The aim of the study is to collect and analyze the multicentric data of the LPL and LS and give a substantial contribution to the scientific community about this very debated topic.

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

Primary outcomes:
measure: Short-term Morbidity
timeFrame: 30 days
measure: Short-term Mortality
timeFrame: 30 days
measure: Optimal Sepsis Control
timeFrame: 30 days
measure: Post-operative Re-interventions Rate
timeFrame: 15 days
Secondary outcomes:
measure: Mean Postoperative Time
timeFrame: 1 day
measure: Average Length of Postoperative Hospital Stay
timeFrame: 30 day
measure: Recurrent Colonic Diverticulitis Rate
timeFrame: 6 months
measure: Incisional Hernia Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero, Universitaria Pisana
state: Tuscany
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Dario Tartaglia, MD
role: PRINCIPAL_INVESTIGATOR
References: