The critical view of safety during keyhole surgical gallbladder removal: Strasberg method yes or no? An Italian multicentre study
| ISRCTN | ISRCTN10815089 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10815089 |
| Secondary identifying numbers | Uniba-5674 |
- Submission date
- 29/01/2020
- Registration date
- 31/01/2020
- Last edited
- 31/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Keyhole surgery for gall bladder removal (laparoscopic cholecystectomy) is currently and worldwide considered the gold standard for the treatment of gallbladder stones. Since its introduction, in the early 1990s, this procedure has gained a remarkable consensus until becoming a routine surgical procedure. However, this procedure comes with an increased incidence of bile duct injuries (BDI), compared to open cholecystectomy (OC): 0.3% and 0.8% vs 0.2%. Strasberg introduced in 1995 the "Critical View of Safety" (CVS) to promote the recognition of the gallbladder elements in order to reduce the risk of BDI and to avoid mistakes due to anatomical alterations and altered visual perception.
The SYoN (Strasberg Yes or No) study is a multicentre Italian observational prospective cohort study, performed by collecting and analysing clinical data of patients managed in 30 Italian surgical departments, affiliated with the Italian Digestive Pathology Society (SIPAD), over a study period of 2 years. The study was conducted prospectively with the insertion of patients on a national database whose data, however, were retrospectively collected after patient discharge not to influence patient management. This prospective study aimed to assess the impact of the correct application of CVS principles during LC on the incidence of postoperative complications, such as BDI and bleeding.
Who can participate?
Adult patients treated with Laparoscopic Cholecystectomy at one of the study sites.
What does the study involve?
Patients will be treated as usual. The data will be collected after patient discharge not to influence patient management. Patients receive the most suitable surgical treatment based on their clinical conditions, the preoperative study, and the intraoperative findings.
What are the possible benefits and risks of participating?
The study doesn’t influence the management of patients causing any risk for participating but aiming to analyse the effective application of CVS in the current surgical practice. This study could be potentially useful to encourage the safest management in case of CVS not applicable such as open conversion and subtotal cholecystectomy.
Where is the study run from?
Department of Biomedical Sciences and Human Oncology - Unit of General Surgery "V. Bonomo" University Medical School of Bari (Italy)
When is the study starting and how long is it expected to run for?
March 2017 to March 2019
Who is funding the study?
Universita degli Studi di Bari Aldo Moro (Italy)
Who is the main contact?
Prof. Mario Testini (scientific)
mario.testini@uniba.it
Dr Lucia Sgaramella (public)
ilaria.sgaram@gmail.com
Contact information
Scientific
Polyclinic Hospital of Bari
Piazza Giulio Cesare, 11
Bari
70124
Italy
 ORCID ID |
0000-0002-9297-4894 |
|---|---|
| Phone | +39 3355370914 |
| mario.testini@uniba.it |
Public
Via P. Carbonara, 22
Bitonto (Bari)
70032
Italy
| ORCID ID |
0000-0002-6087-4119 |
|---|---|
| Phone | +39 3468521216 |
| ilaria.sgaram@gmail.com |
Study information
| Study design | Multicentre observational prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The impact of the correct application of critical view of safety (CVS) principles during laparoscopic cholecystectomy on the incidence of postoperative complications |
| Study acronym | SYoN |
| Study hypothesis | The CVS is the safest technique for recognizing the elements of the Calot triangle and in preventing intra-operative complications (iatrogenic lesions and perioperative bleeding). |
| Ethics approval(s) | Approved 17/10/2018, Ethics Committee of the University of Bari (Policlinico di Bari - P.zza G. Cesare n. 11, Bari- 70124, Italy; +39 (0)80 5593399; comitatoetico@policlinico.ba.it), ref: 5674 |
| Condition | Acute cholecystitis and cholelithiasis |
| Intervention | All members of SIPAD society (Italian Digestive Pathology Society) will be invited by email to participate in the study through an online questionnaire. The questionnaire (23 questions divided into six forms) examines the preoperative workup, the laparoscopic training of the first surgeon, the intraoperative management of the patient, and the post-operative phase concerning any BDI and peri-operative bleeding. Patients submitted to emergency LC for acute cholecystitis, elective LC for chronic pathologies, and patients treated with LC during other major laparoscopic surgeries are eligible for inclusion if a proper preoperative examination is conducted by the operating surgeon. In case of declared CVS, the surgeon is asked to judge personally at the end of the procedure if the isolation of the elements is performed according to all the points described by Strasberg, and subsequently to attach an iconographic item (Video or "Doublet Photography") in case of dissection of the Calot triangle with CVS. During compilation, the iconographic documentation (video or photo) is sent to a dedicated encrypted email address indicating the date of the surgery, the patient's initials, the date of birth and the recruiting centre. Data collection, compiled by the recruiting centre, is centrally recorded into an electronic database of the data manager (SIPAD), which also ensured the blinding of the lead operator. Finally, an expert surgeon with high skill in hepatobiliary and laparoscopic surgery will review, as external auditor, all the iconographic documentation to establish the strict adherence of the declared manoeuvre with the three principles of the CVS of Strasberg. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured using patient records 1. Rate of Bile Duct Injuries 2. Rate of bleeding |
| Secondary outcome measures | Measured using patient records: 1. Duration of surgery in minutes 2. Length of a hospital stay 3. Operator-related risk factors 4. Patient-related risk factors |
| Overall study start date | 01/01/2017 |
| Overall study end date | 01/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 650 |
| Participant inclusion criteria | 1. Patients submitted to emergency Laparoscopic Cholecystectomy for acute cholecystitis 2. Patients submitted to elective Laparoscopic Cholecystectomy for cholelitiasis 3. Patients treated with Laparoscopic Cholecystectomy during other major laparoscopic surgeries |
| Participant exclusion criteria | 1. Patients submitted to open cholecystectomy 2. Patients submitted to laparoscopy converted to open surgery 3. Patients submitted to surgery with evidence of malignant pathologies of the gallbladder |
| Recruitment start date | 01/03/2017 |
| Recruitment end date | 01/03/2019 |
Locations
Countries of recruitment
- Italy
Study participating centres
Piazza G. Cesare, 11
Bari
70124
Italy
Via Vittorio Veneto, 197
La Spezia
19121
Italy
via Pietro Nenni 20-22
Arezzo
52100
Italy
via Degasperi 31
Cles
38023
Italy
Via Guglielmo Marconi, 160
Quartu Sant'Elena
09045
Italy
Largo Rosanna Benzi, 10
Genova
16132
Italy
Via Sergio Pansini, 5
Naples
80131
Italy
Viale Antonio Gramsci, 14
Parma
43126
Italy
Largo Rosanna Benzi, 10
Genova
16132
Italy
Via Circonvallazione, 1
San Bonifacio
37047
Italy
Via Bezzecca, 10
Brescia
25128
Italy
Viale Giacomo Matteotti, 83
Sesto San Giovanni
20099
Italy
Viale Camillo Golgi, 19
Pavia
27100
Italy
Avellino AV
83100
Italy
Via G.B Grassi, 74
Milano
20157
Italy
Via dei Ponderanesi, 2
Biella
13875
Italy
Via Luigi Russo, 6
Caltanissetta
93100
Italy
Piazza Luigi Miraglia, 2
Naples
80138
Italy
Via Suor Niccolina Infermiera, 20/22
Prato
59100
Italy
Piazza G. Cesare, 11
Bari
70124
Italy
Via Liborio Giuffré 5
Palermo
90127
Italy
Sponsor information
Hospital/treatment centre
Unit of General Surgery "V. Bonomo"
Department of Biomedical Sciences and Human Oncology
University Medical School "Aldo Moro" of Bari
Piazza Giulio Cesare, 11
Bari
70124
Italy
| Phone | +39 3355370914 |
|---|---|
| mario.testini@uniba.it | |
| Website | http://www.uniba.it/english-version |
"ROR" |
https://ror.org/027ynra39 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Bari Aldo Moro
- Location
- Italy
Results and Publications
| Intention to publish date | 01/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in Surgical Endoscopy. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
31/01/2020: Trial’s existence confirmed by Ethics Committee of the University of Bari.
