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NCT Number: NCT05208385

Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age above 18 years
  • symptomatic cholelithiasis

Exclusion criteria

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

Treatment and study plan

video-assisted umbilical closure

Procedure

video-assisted umbilical closure

Other names: standard umbilical fascial closure

Primary outcomes

  1. Trocar site hernia (TSH)

    Time frame: 18 months

    trocar site hernia presence

Secondary outcomes

  1. Wound infection (WI)

    Time frame: three weeks later

    wound infection

  2. Hematoma (H)

    Time frame: 18 months (postoperative first day and three weeks later)

    Hematoma

  3. Length of hospital stay (LOH)

    Time frame: 18 months

    length of hospital stay (day)

  4. 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)

Sponsors and collaborators

Lead sponsor

Samsun Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2022
Registry last updated
Feb 10, 2022

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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