Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidect... | NCT03008707

Status Module

Sponsor/Collaborators Module

Name	Class
Ospedale San Jacopo, Pistoia	UNKNOWN
S. Andrea Hospital	OTHER
Maggiore Bellaria Hospital, Bologna	OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients who undergo Laparoscopic Peritoneal Lavage	Procedure: Laparoscopic Peritoneal Lavage
Group 2		Patients who have a laparoscopically approached sigmoidectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic Peritoneal Lavage	Procedure	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

Outcomes Module

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

Measure	Description	Time Frame
Mean Postoperative Time		1 day
Average Length of Postoperative Hospital Stay		30 day
Recurrent Colonic Diverticulitis Rate

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dario Tartaglia, MD	Azienda Ospedaliero, Universitaria Pisana	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliero, Universitaria Pisana		Pisa	Tuscany	56021	Italy

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 18, 2017	Aug 26, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	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
BG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00028 BG00138 BG00266

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00059.25± 13.21 BG00155.68± 10.81 BG00257.19± 11.92

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00015 BG00112 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Short-term Morbidity

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG00027 OG00138

Title

Denominators

Categories

Title	Measurements
	OG0008 OG0011

Primary

Short-term Mortality

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG000

Primary

Optimal Sepsis Control

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG000

Primary

Post-operative Re-interventions Rate

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Count of Participants

Participants

15 days

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG000

Secondary

Mean Postoperative Time

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Mean

Standard Deviation

minutes

1 day

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG000

Secondary

Average Length of Postoperative Hospital Stay

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Mean

Standard Deviation

days

30 day

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG000

Secondary

Recurrent Colonic Diverticulitis Rate

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG000

Secondary

Incisional Hernia Rate

In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	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
OG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	27	0	27	0	27
EG001	Laparoscopically Approached Sigmoidectomy	Patients who have a laparoscopically approached sigmoidectomy	0	38	0	38	0	38