Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT03768661|
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
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.
|Condition or disease||Intervention/treatment|
|Cholelithiasis||Procedure: Single-incision Laparoscopic cholecystectomy Procedure: Laparoscopic Cholecystectomy|
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.
|Study Type :||Observational|
|Actual Enrollment :||185 participants|
|Official Title:||Long-term Incisional Hernia Rate After Single-Incision Laparoscopic Cholecystectomy (SILC) in Front of Standard Laparoscopy|
|Actual Study Start Date :||July 1, 2009|
|Actual Primary Completion Date :||June 30, 2011|
|Actual Study Completion Date :||November 1, 2017|
patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy
Procedure: Single-incision Laparoscopic cholecystectomy
laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision
patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy
Procedure: Laparoscopic Cholecystectomy
laparoscopic cholecystectomy performed using three-trocars standard technique
- incisional hernia rate [ Time Frame: 5 years ]Incisional Hernia by clinical examination or CT scan
- operating time of the procedure [ Time Frame: During the perioperative period ]Total duration of the surgical procedure (in minutes)
- postoperative complications 1 [ Time Frame: Rate of participants suffering from biliary complication assesed after 30 days of follow-up ]biliary leak or bile duct injury
- postoperative complications 2 [ Time Frame: Rate of participants who needed reoperation assesed after 30 days of follow-up ]reoperations
- postoperative complications 3 [ Time Frame: Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up ]surgical site occurrence
- cosmetic satisfaction [ Time Frame: 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 ]patient's cosmetic evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768661
|Barcelona, Spain, 08006|
|Principal Investigator:||Carlos Hoyuela, MD PhD||Chief, Dept. of Surgery|