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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:
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:
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
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:
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
Postoperative clinical findings
In-hospital postoperative complications
Early and late surgery-related complications after discharge
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic-lavage | Patients with colonic diverticulitis submitted to laparoscopic lavage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic-lavage | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| success rate | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| conversion to any form of laparoscopy | conversion to any form of laparoscopy different from peritoneal lavage (with or without bowel resection) | intraoperative |
| conversion to laparotomy | conversion to laparotomy (with or without bowel resection) |
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Inclusion criteria Patients with colonic diverticulitis submitted to laparoscopic lavage
Exclusion criteria Patients with occasional finding of colo-rectal cancer
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Each patient is required to meet all of the inclusion criteria and none of the exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gian Andrea Binda, MD | Ospedali Galliera, Genova, Italy | Principal Investigator |
| Roberto Cirocchi, MD | University of Perugia - Terni | Principal Investigator |
| Salomone Di Saverio, MD | Maggiore Hospital, AUSL Bologna, Italy | Principal Investigator |
| Nereo Vettoretto, MD | Ospedale Montichiari, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gian Andrea Binda | Genova | Italy |
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| ID | Term |
|---|---|
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| intraoperative |
| 30 days post-operative mortality | 30 days |
| 30 days post-operative surgical re-interventions rate | 30 days |
| 30 days post-operative percutaneous drainage rate | 30 days |
| hospital readmission rate for recurrence of diverticulitis | 30 days |
| visualisation of colonic perforation | rate of visualisation of colonic perforation during laparoscopic peritoneal lavage | intraoperative |
| visceral adhesiolysis | consistency, if any, of visceral adhesiolysis performed during the procedure | intraoperative |
| duration of follow-up | 12 |
| post-lavage elective resection rate (lavage "bridge" to resection) | 12 months |