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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
Sponsor:
Information provided by (Responsible Party):
Hospital Plató

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.


Condition or disease Intervention/treatment
Cholelithiasis Procedure: Single-incision Laparoscopic cholecystectomy Procedure: Laparoscopic Cholecystectomy

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.


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Study Type : Observational
Actual Enrollment : 185 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones Hernia

Group/Cohort Intervention/treatment
SILC Group
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

Laparoscopy Group
patients with symptomatic cholelithiasis submitted to a standard three trocar laparoscopic cholecystectomy
Procedure: Laparoscopic Cholecystectomy
laparoscopic cholecystectomy performed using three-trocars standard technique




Primary Outcome Measures :
  1. incisional hernia rate [ Time Frame: 5 years ]
    Incisional Hernia by clinical examination or CT scan


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)
Criteria

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

Information from the National Library of Medicine

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


Locations
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Spain
Hospital Plató
Barcelona, Spain, 08006
Sponsors and Collaborators
Hospital Plató
Investigators
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Principal Investigator: Carlos Hoyuela, MD PhD Chief, Dept. of Surgery

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Plató
ClinicalTrials.gov Identifier: NCT03768661     History of Changes
Other Study ID Numbers: HPlato
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Plató:
cholecystectomy
laparoscopy
single-incision laparoscopic surgery
incisional hernia
trocar-site hernia

Additional relevant MeSH terms:
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Cholelithiasis
Cholecystolithiasis
Gallstones
Hernia
Incisional Hernia
Surgical Wound
Pathological Conditions, Anatomical
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi