Incisional Hernia Rate After Single-incision Laparoscopic Cholecystectomy

April 13, 2020 updated by: Hospital Plató

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08006
        • Hospital Plató

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- patients over 18 years with cholelithiasis and candidates for elective surgery (cholecystectomy)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incisional hernia rate
Time Frame: 5 years
Incisional Hernia by clinical examination or CT scan
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operating time of the procedure
Time Frame: During the perioperative period
Total duration of the surgical procedure (in minutes)
During the perioperative period
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
Rate of participants suffering from biliary complication assesed after 30 days of follow-up
postoperative complications 2
Time Frame: Rate of participants who needed reoperation assesed after 30 days of follow-up
reoperations
Rate of participants who needed reoperation assesed after 30 days of follow-up
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
Rate of participants suffering from seroma and/or wound infection assesed after 30 days of follow-up
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Plató

Investigators

  • Principal Investigator: Carlos Hoyuela, MD PhD, Chief, Dept. of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2009

Primary Completion (Actual)

June 30, 2011

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SILS Chole Hernia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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