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

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

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

Study Overview

• Status: Completed
• Conditions: Acute Diverticulitis
• Intervention / Treatment: Procedure: Laparoscopic Peritoneal Lavage

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Pisa, Tuscany, Italy, 56021
      • Azienda Ospedaliero, Universitaria Pisana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with complicated acute diverticulitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients who undergo Laparoscopic Peritoneal Lavage	Procedure: 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
Group 2; Patients who have a laparoscopically approached sigmoidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana
• Collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna; George Papanicolaou Hospital; Hospitales Universitarios Virgen del Rocío; A.O. Ospedale Papa Giovanni XXIII; Maggiore Bellaria Hospital, Bologna; S. Andrea Hospital; Ospedale San Jacopo, Pistoia
• Investigators: Principal Investigator: Dario Tartaglia, MD, Azienda Ospedaliero, Universitaria Pisana

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopic sigmoidectomy; Laparoscopic peritoneal lavage; complicated acute diverticulitis; D004238
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: n° 890