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Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05208385
Enrollment
240
Registered
2022-01-26
Start date
2021-01-01
Completion date
2021-12-27
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis (Without Cholecystitis), Hernia Incisional, Pain, Postoperative

Keywords

laparoscopic cholecystectomy, pain, trocar site hernia

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.

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.

Interventions

PROCEDUREvideo-assisted umbilical closure

video-assisted umbilical closure

Sponsors

Samsun Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Trocar site hernia (TSH)18 monthstrocar site hernia presence

Secondary

MeasureTime frameDescription
Wound infection (WI)three weeks laterwound infection
Hematoma (H)18 months (postoperative first day and three weeks later)Hematoma
Length of hospital stay (LOH)18 monthslength of hospital stay (day)
Abdominal PainPreoperative first day, postoperative first dayAbdominal pain assessment by visual analog scale (0 minimum-10 maximum values, higher scores mean worse outcome)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026