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Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03768661
Enrollment
185
Registered
2018-12-07
Start date
2009-07-01
Completion date
2017-11-01
Last updated
2020-04-14

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

Conditions

Cholelithiasis

Keywords

cholecystectomy, laparoscopy, single-incision laparoscopic surgery, incisional hernia, trocar-site hernia

Brief summary

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

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.

Interventions

PROCEDURESingle-incision Laparoscopic cholecystectomy

laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision

PROCEDURELaparoscopic Cholecystectomy

laparoscopic cholecystectomy performed using three-trocars standard technique

Sponsors

Hospital Plató
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
incisional hernia rate5 yearsIncisional Hernia by clinical examination or CT scan

Secondary

MeasureTime frameDescription
operating time of the procedureDuring the perioperative periodTotal duration of the surgical procedure (in minutes)
postoperative complications 1Rate of participants suffering from biliary complication assesed after 30 days of follow-upbiliary leak or bile duct injury
postoperative complications 2Rate of participants who needed reoperation assesed after 30 days of follow-upreoperations
postoperative complications 3Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-upsurgical site occurrence
cosmetic satisfactionpatient's own cosmetic evaluation using a visual analogue score ranging from 0 to 10 (0=worst to 10=best) after 30 days of follow-uppatient's cosmetic evaluation

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026