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Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

Sponsor
Samsun Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05208385
Collaborator
(none)
240
Enrollment
1
Location
2
Arms
11.8
Actual Duration (Months)
20.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: video-assisted umbilical closure
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effectiveness of the Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy: Prospective Randomized Clinical Trial of 240 Patients
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Dec 24, 2021
Actual Study Completion Date :
Dec 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Standard umbilical trocar incision closure (UC)

standard umbilical trocar incision closure

Procedure: video-assisted umbilical 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

    Procedure: video-assisted umbilical closure
    video-assisted umbilical closure
    Other Names:
  • standard umbilical fascial closure

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Trocar site hernia (TSH) [18 months]

      trocar site hernia presence

    Secondary Outcome Measures

    1. Wound infection (WI) [three weeks later]

      wound infection

    2. Hematoma (H) [18 months (postoperative first day and three weeks later)]

      Hematoma

    3. Length of hospital stay (LOH) [18 months]

      length of hospital stay (day)

    4. Abdominal Pain [Preoperative first day, postoperative first day]

      Abdominal pain assessment by visual analog scale (0 minimum-10 maximum values, higher scores mean worse outcome)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age above 18 years

    • symptomatic cholelithiasis

    Exclusion Criteria:

    • acute cholecystitis

    • age under 18 years

    • previous umbilical hernia repair

    • pre-existing umbilical hernia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsun Education and Research Hospital Samsun Turkey 55060

    Sponsors and Collaborators

    • Samsun Education and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Elif Colak, Associate Professor, Samsun Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05208385
    Other Study ID Numbers:
    • KAEK2020/3 /1
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elif Colak, Associate Professor, Samsun Education and Research Hospital
    laparoscopic cholecystectomy
    pain
    trocar site hernia
    Additional relevant MeSH terms:
    Cholecystitis
    Cholelithiasis
    Cholecystolithiasis
    Gallstones
    Hernia
    Pain, Postoperative
    Incisional Hernia

    Study Results

    No Results Posted as of Feb 10, 2022