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

Completed

• Conditions: Acute Diverticulitis
• Interventions: Procedure: Laparoscopic Peritoneal Lavage

• Registration Number: NCT03008707
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-02
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Results First Submitted: 2019-06-07
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Results First Posted: 2019-09-25
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Laparoscopic Peritoneal Lavage	Patients who undergo Laparoscopic Peritoneal Lavage

Primary Outcome Measures

Name	Time	Method
Short-term Mortality	30 days
Optimal Sepsis Control	30 days
Short-term Morbidity	30 days
Post-operative Re-interventions Rate	15 days

Secondary Outcome Measures

Name	Time	Method
Mean Postoperative Time	1 day
Recurrent Colonic Diverticulitis Rate	6 months
Average Length of Postoperative Hospital Stay	30 day
Incisional Hernia Rate	6 months

Trial Locations

Locations (1)

Azienda Ospedaliero, Universitaria Pisana; 🇮🇹 Pisa, Tuscany, Italy