Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

Samsun Education and Research Hospital

Status: Completed

Conditions: Hernia Incisional; Pain, Postoperative; Cholelithiasis (Without Cholecystitis)

Treatments: Procedure: video-assisted umbilical closure

Study type: Interventional

Funder types: Other

Identifiers

NCT05208385

KAEK2020/3 /1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age above 18 years
• symptomatic cholelithiasis

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Standard umbilical trocar incision closure (UC)

Other group

Description:

standard umbilical trocar incision closure

Treatment:

Procedure: video-assisted umbilical closure

Video-assisted umbilical trocar incision closure (UCVA))

Active Comparator group

Description:

video-assisted umbilical trocar incision closure

Treatment:

Procedure: video-assisted umbilical closure