Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03008707
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2016-12-29
Brief Title:
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis a Multicenter Prospective Observational Study STELLA Study
Sponsor:
Azienda Ospedaliero Universitaria Pisana
Organization:
Azienda Ospedaliero Universitaria Pisana
Study Overview
Official Title:
Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis a Multicenter Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STELLA
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 Hincheys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None