Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-01

Study Completion Date

2017-11-01

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.

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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.

Conditions

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Cholelithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SILC Group

patients with symptomatic cholelithiasis submitted to a single-incision laparoscopic cholecystectomy

Single-incision Laparoscopic cholecystectomy

Intervention Type PROCEDURE

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

Laparoscopy Group

patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy

Laparoscopic Cholecystectomy

Intervention Type PROCEDURE

laparoscopic cholecystectomy performed using three-trocars standard technique

Interventions

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Single-incision Laparoscopic cholecystectomy

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

Intervention Type PROCEDURE

Laparoscopic Cholecystectomy

laparoscopic cholecystectomy performed using three-trocars standard technique

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No