Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study (STELLA Study)

Azienda Ospedaliero, Universitaria Pisana

Status: Completed

Conditions: Acute Diverticulitis

Treatments: Procedure: Laparoscopic Peritoneal Lavage

Study type: Observational

Funder types: Other

Identifiers

NCT03008707

n° 890

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

66 participants in 2 patient groups

Group 1

Description:

Patients who undergo Laparoscopic Peritoneal Lavage

Treatment:

Procedure: Laparoscopic Peritoneal Lavage

Group 2

Description:

Patients who have a laparoscopically approached sigmoidectomy