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

Study Overview
=================
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.

Official Title
-----------------
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study

Conditions
-----------------
Acute Diverticulitis

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Peritoneal Lavage


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients who undergo Laparoscopic Peritoneal Lavage | Procedure: Laparoscopic Peritoneal Lavage<br>* LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites<br>|
| Group 2<br>Patients who have a laparoscopically approached sigmoidectomy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term Morbidity |  | 30 days | 
| Short-term Mortality |  | 30 days | 
| Optimal Sepsis Control |  | 30 days | 
| Post-operative Re-interventions Rate |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Postoperative Time |  | 1 day | 
| Average Length of Postoperative Hospital Stay |  | 30 day | 
| Recurrent Colonic Diverticulitis Rate |  | 6 months | 
| Incisional Hernia Rate |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic peritoneal lavage, laparoscopic sigmoidectomy, complicated acute diverticulitis, D004238