Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Single-incision laparoscopic cholecystectomy (SILC) requires a larger incision than standard laparoscopy, which may increase the incidence of incisional hernias. This study evaluated SILC and standard multiport cholecystectomy with respect to perioperative outcomes, hospital stay, cosmetic results, and postoperative complications, including the 5-years incisional hernia rate.

Detailed Description
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A cohort study was performed for patients who underwent a laparoscopic cholecystectomy under an institutional review approved protocol. Between 2009 and 2011, 45 unselected patients underwent SILC performed by the same two surgeons. The study inclusion criteria were the following: patients over 18 years with cholelithiasis, and candidates for elective surgery with no significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4). The exclusion criteria included the following: acute cholecystitis, associated CBD stones or pancreatitis, an emergency operation for complicated disease, mental illness, or patient refusal and/or absence of informed consent. All included patients signed a standard consent form after being informed about the characteristics of the SILC procedure. The outcomes of these patients were compared with those of a control cohort series of 140 patients who underwent standard LC (with the same inclusion and exclusion criteria) during the same period. The primary endpoint of the study was to determine the incisional hernia rate at the umbilical wound after 5 years of follow-up. Hernias were defined as evidence of a hernia at the clinical examination or those confirmed by ultrasound examination in case of clinical doubt. The study secondary endpoints included the following: duration of surgery (from the start of the incision to skin closure), intraoperative and postoperative complications (30 days), hospital stay, and cosmetic satisfaction results (measured using a visual analogue scale score ranging from 0 to 10). The following variables were also collected: age, gender, body mass index (BMI) and comorbidities. The anesthetic risk was measured according to the ASA classification system. Prolonged hospital stay (more than 24 h) and readmission (patients who returned for medical consultation before scheduled follow-up) were also recorded. All data were collected prospectively.

Official Title
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Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy

Conditions
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Cholelithiasis

Intervention / Treatment
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* Procedure: Single-incision Laparoscopic cholecystectomy
* Procedure: Laparoscopic Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy) abscence of significant cardiopulmonary, hepatic or renal impairment (ASA score less than 4) Exclusion Criteria: acute cholecystitis associated common bile duct stones or pancreatitis emergency operation for complicated disease ASA 4 (American Society of Anesthesiologists) pregnancy mental illness patient refusal and/or absence of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SILC Group<br>patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy | Procedure: Single-incision Laparoscopic cholecystectomy<br>* laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision<br>|
| Laparoscopy Group<br>patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy | Procedure: Laparoscopic Cholecystectomy<br>* laparoscopic cholecystectomy performed using three-trocars standard technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incisional hernia rate | Incisional Hernia by clinical examination or CT scan | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time of the procedure | Total duration of the surgical procedure (in minutes) | During the perioperative period | 
| postoperative complications 1 | biliary leak or bile duct injury | Rate of participants suffering from biliary complication assesed after 30 days of follow-up | 
| postoperative complications 2 | reoperations | Rate of participants who needed reoperation assesed after 30 days of follow-up | 
| postoperative complications 3 | surgical site occurrence | Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up | 
| cosmetic satisfaction | patient's cosmetic evaluation | patient's own cosmetic evaluation using a visual analogue score ranging from 0 to 10 (0=worst to 10=best) after 30 days of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecystectomy, laparoscopy, single-incision laparoscopic surgery, incisional hernia, trocar-site hernia