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Completed

NCT Number: NCT03008707

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero, Universitaria Pisana

Pisa, Tuscany, 56021, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Short-term Morbidity

    Time frame: 30 days

  2. Short-term Mortality

    Time frame: 30 days

  3. Optimal Sepsis Control

    Time frame: 30 days

  4. Post-operative Re-interventions Rate

    Time frame: 15 days

Secondary outcomes

  1. Mean Postoperative Time

    Time frame: 1 day

  2. Average Length of Postoperative Hospital Stay

    Time frame: 30 day

  3. Recurrent Colonic Diverticulitis Rate

    Time frame: 6 months

  4. Incisional Hernia Rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Collaborators

  • A.O. Ospedale Papa Giovanni XXIII
  • George Papanicolaou Hospital
  • Hospitales Universitarios Virgen del Rocío
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • Maggiore Bellaria Hospital, Bologna
  • Ospedale San Jacopo, Pistoia
  • S. Andrea Hospital

Registry information

Official study title

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

Acronym: STELLA

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2017
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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