Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

January 26, 2022 updated by: Elif Colak, Samsun Education and Research Hospital

Effectiveness of the Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy: Prospective Randomized Clinical Trial of 240 Patients

A prospective randomized study was performed including consecutive patients who underwent an elective laparoscopic cholecystectomy (LC) for symptomatic cholelithiasis during the 18 months period. This prospective randomized trial aims to compare two umbilical closure techniques for trocar site hernia (TSH) in laparoscopic cholecystectomy.

Study Overview

Detailed Description

Laparoscopic cholecystectomy (LC) is currently the gold standard in the treatment for symptomatic cholelithiasis that offers a variety of advantages over conventional open surgery such as shorter recovery time, better cosmesis, less wound complication rates, and less pain (1,2). Despite these advantages, LC can result in unique complications. Among these complications, trocar site hernia (TSH) is one of the most important complications because laparoscopic cholecystectomy promises smaller abdominal incisions and better cosmetic outcomes. A second surgical intervention due to TSH may overshadow the gains of the previous laparoscopic surgery. In studies conducted to date, the rate of trocar hernia in laparoscopic cholecystectomy has been presented at very different rates. Many studies have shown that the most frequent site of TSH is the umbilical trocar site (3-6).

To avoid this important complication of laparoscopic cholecystectomy, many different techniques have been described to date for trocar port fascia repair (7-12). Most of these techniques require special devices. In addition, a few studies compare these techniques with standard fascial closure, which is mostly used by surgeons (11,12).

We hypothesized that the fascial closure of the umbilical trocar incision under the intra-abdominal vision with the laparoscopic camera could be reduced TSH. This prospective randomized controlled study aims to assess whether fascial closure of umbilical trocar site under direct laparoscopic vision in LC can reduce the incidence of TSH.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

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

      • Samsun, Turkey, 55060
        • Samsun Education and Research Hospital

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age above 18 years
  • symptomatic cholelithiasis

Exclusion Criteria:

  • acute cholecystitis
  • age under 18 years
  • previous umbilical hernia repair
  • pre-existing umbilical hernia

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard umbilical trocar incision closure (UC)
standard umbilical trocar incision closure
video-assisted umbilical closure
Other Names:
  • standard umbilical fascial closure
Active Comparator: Video-assisted umbilical trocar incision closure (UCVA))
video-assisted umbilical trocar incision closure
video-assisted umbilical closure
Other Names:
  • standard umbilical fascial closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trocar site hernia (TSH)
Time Frame: 18 months
trocar site hernia presence
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection (WI)
Time Frame: three weeks later
wound infection
three weeks later
Hematoma (H)
Time Frame: 18 months (postoperative first day and three weeks later)
Hematoma
18 months (postoperative first day and three weeks later)
Length of hospital stay (LOH)
Time Frame: 18 months
length of hospital stay (day)
18 months
Abdominal Pain
Time Frame: Preoperative first day, postoperative first day
Abdominal pain assessment by visual analog scale (0 minimum-10 maximum values, higher scores mean worse outcome)
Preoperative first day, postoperative first day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Elif Colak, Samsun Education and Research Hospital

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

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)

January 1, 2021

Primary Completion (Actual)

December 24, 2021

Study Completion (Actual)

December 27, 2021

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The datasets generated during the current study are available.

IPD Sharing Time Frame

January 2021

IPD Sharing Access Criteria

The datasets generated during the current study are available.

IPD Sharing Supporting Information Type

  • Study Protocol

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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