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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03008707

Acronym

STELLA

Enrollment

Registered

2017-01-02

Start date

2015-11-30

Completion date

2018-12-31

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diverticulitis

Keywords

Laparoscopic peritoneal lavage, laparoscopic sigmoidectomy, complicated acute diverticulitis, D004238

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.

Interventions

PROCEDURELaparoscopic Peritoneal Lavage

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Italy

Participant flow

Participants by arm

Arm	Count
Laparoscopic Peritoneal Lavage Patients who undergo Laparoscopic Peritoneal Lavage Laparoscopic Peritoneal Lavage: 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	28
Laparoscopically Approached Sigmoidectomy Patients who have a laparoscopically approached sigmoidectomy	38
Total	66

Baseline characteristics

Characteristic	Laparoscopically Approached Sigmoidectomy	Total	Laparoscopic Peritoneal Lavage
Age, Continuous	55.68 years STANDARD_DEVIATION 10.81	57.19 years STANDARD_DEVIATION 11.92	59.25 years STANDARD_DEVIATION 13.21
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	38 Participants	66 Participants	28 Participants
Sex: Female, Male Female	12 Participants	27 Participants	15 Participants
Sex: Female, Male Male	26 Participants	39 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 38
other Total, other adverse events	0 / 27	0 / 38
serious Total, serious adverse events	0 / 27	0 / 38