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

NCT ID: NCT03008707

Last Updated: 2019-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Acute Diverticulitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients who undergo Laparoscopic Peritoneal Lavage

Laparoscopic Peritoneal Lavage

Intervention Type 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

Group 2

Patients who have a laparoscopically approached sigmoidectomy

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Jacopo, Pistoia

UNKNOWN

Sponsor Role collaborator

S. Andrea Hospital

OTHER

Sponsor Role collaborator

Maggiore Bellaria Hospital, Bologna

OTHER

Sponsor Role collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role collaborator

A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

George Papanicolaou Hospital

OTHER

Sponsor Role collaborator

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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Dario Tartaglia

MD, PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dario Tartaglia, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero, Universitaria Pisana

Locations

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Azienda Ospedaliero, Universitaria Pisana

Pisa, Tuscany, Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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n° 890

Identifier Type: -

Identifier Source: org_study_id

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