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Laparoscopic-lavage Observational Study

Laparoscopic-lavage Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02662088
Acronym
LLOS
Enrollment
404
Registered
2016-01-25
Start date
2016-06-30
Completion date
2018-01-31
Last updated
2019-04-17

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

Conditions

Diverticulitis

Brief summary

The purpose of this study is to collect a multi-institutional database including all relevant data regarding the surgical and clinical features of patients underwent to laparoscopic lavage for complicated colic diverticulitis. The main objectives are: * To determine the surgical and clinical outcomes, in the short and long term. * To compare results according to the different type of techniques, device used and manner of execution of the different surgical steps. * To relate results of different surgeries with baseline characteristics of patients and stage of disease.

Detailed description

The purpose of this study is to collect a multi-institutional database including all relevant data regarding the surgical and clinical features of patients underwent to laparoscopic lavage for complicated colic diverticulitis. The main objectives are: * To determine the surgical and clinical outcomes, in the short and long term. * To compare results according to the different type of techniques, device used and manner of execution of the different surgical steps. * To relate results of different surgeries with baseline characteristics of patients and stage of disease. This ad hoc registry will allow centers to retrospectively fill in the data of their patients; the information will be obtained from existing records, diagnostic tests and surgical intervention descriptions. Data will be collected and recorded by all institutions through a specific online shared system. To facilitate and standardize data collection through a shared database and to ensure the safety of sensitive data, a special online computerized web system has been developed. Investigators have to provide the required data as fully as possible; however, the lack of certain data does not preclude from sending the remaining data. Specific aims * Analyze general outcome * Analyze the different techniques of laparoscopic lavage * Analyze the different inclusion criteria * Analyze the different follow-up Primary outcome for this retrospective observational study is: the success rate of laparoscopic peritoneal lavage, defined as the rate of patients alive with no need of further surgical treatment for recurrent attacks of diverticulitis. Secondary outcomes are: * conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection) * conversion to laparotomy (with or without bowel resection) * 30 days post-operative mortality; * 30 days post-operative surgical re-interventions rate; * 30 days post-operative percutaneous drainage rate; * hospital readmission rate for recurrence of diverticulitis; * \- rate of visualisation of colonic perforation during laparoscopic peritoneal lavage; * surgical strategies used in case of detection of a colonic perforation; * consistency, if any, of visceral adhesiolysis performed during the procedure; * duration of follow-up * post-lavage elective resection rate (lavage bridge to resection) Eligibility Each patient is required to meet all of the inclusion criteria and none of the exclusion criteria. Inclusion criteria Patients with colonic diverticulitis submitted to laparoscopic lavage Exclusion criteria Patients with occasional finding of colo-rectal cancer Data collection Patient demographics * Year of birth * Sex * Body Mass Index (BMI) * ASA score * Haemodynamic condition (stable or unstable) * Previous abdominal surgery * Previous events of diverticulitis requiring ambulatory investigation or treatment * Previous events of diverticulitis requiring hospitalization * Abdominal CT scan before surgery (yes/no) and WSES stage (Sartelli M, Moore FA, Ansaloni L, Di Saverio S, Coccolini F, Griffiths EA, et al. A proposal for a CT driven classification of left colon acute diverticulitis. World J Emerg Surg. 2015 World 2015; 10: 3) Surgery * Date of Operation * Hinchey score (modified Kaiser AM, Jiang JK, Lake JP, Ault G, Artinyan A, Gonzalez-Ruiz C, Essani R, Beart RW Jr. The management of complicated diverticulitis and the role of computed tomography. Am J Gastroenterol 2005; 100: 910-917) * Number of trocars inserted * Quantity of lavage (cc) * Conversion rate to any laparoscopic technique either than lavage * Conversion rate to any type of open surgical technique * Degree of adhesiolysis performed for searching eventual free colonic perforation (1. none, 2. lysis of weak adhesions, 3. actively searching for any collection with consistent amount of adhesiolysis) * Identification of a free colonic perforation during the laparoscopic peritoneal lavage * Surgical strategies used in case of detection of a colonic perforation (drainage, stitching, resection) * Placement of intra-abdominal drain (number and location) * Operative time * Estimated blood loss * Intraoperative complications * Intraoperative death Postoperative clinical findings * Length of postoperative hospital stays * Postoperative blood transfusion * Liquid diet (POD number) * Soft solid diet (POD number) * Re-establishment of peristalsis (POD number) * First pass of flatus (POD number) * Drain removal (POD number) * Length and type of intravenous antibiotic use * Length of intravenous analgesic use In-hospital postoperative complications * Type of complication * Re-operation for complication * Dindo-Clavien Grade Early and late surgery-related complications after discharge * Date of hospitalization for diverticulitis recurrence * Type of complication * Death related to the complication * Need of surgery (type of surgery) * Need percutaneous drainage * Need peritoneal lavage Follow-up * Date of last follow-up visit * post-Lap lavage elective resection rate (lavage as a bridge to resection) * Indication to resection (symptoms, prophilaxys of further episodes of acute diverticulitis)

Interventions

PROCEDURElaparoscopic-lavage

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with colonic diverticulitis submitted to laparoscopic lavage

Exclusion criteria

Patients with occasional finding of colo-rectal cancer

Design outcomes

Primary

MeasureTime frameDescription
success rate12 monthsthe success rate of laparoscopic peritoneal lavage, defined as the rate of patients alive with no need of further surgical treatment for recurrent attacks of diverticulitis

Secondary

MeasureTime frameDescription
conversion to laparotomyintraoperativeconversion to laparotomy (with or without bowel resection)
30 days post-operative mortality30 days
30 days post-operative surgical re-interventions rate30 days
30 days post-operative percutaneous drainage rate30 days
conversion to any form of laparoscopyintraoperativeconversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection)
visualisation of colonic perforationintraoperativerate of visualisation of colonic perforation during laparoscopic peritoneal lavage
visceral adhesiolysisintraoperativeconsistency, if any, of visceral adhesiolysis performed during the procedure
duration of follow-up12
post-lavage elective resection rate (lavage bridge to resection)12 months
hospital readmission rate for recurrence of diverticulitis30 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026