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Completed

NCT Number: NCT03768661

Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Plató

Barcelona, 08006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-incision Laparoscopic cholecystectomy

Procedure

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

Laparoscopic cholecystectomy

Procedure

laparoscopic cholecystectomy performed using three-trocars standard technique

Primary outcomes

  1. incisional hernia rate

    Time frame: 5 years

    Incisional Hernia by clinical examination or CT scan

Secondary outcomes

  1. operating time of the procedure

    Time frame: During the perioperative period

    Total duration of the surgical procedure (in minutes)

  2. 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

  3. postoperative complications 2

    Time frame: Rate of participants who needed reoperation assesed after 30 days of follow-up

    reoperations

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Hospital Plató

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2017
First posted
Dec 7, 2018
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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