Video-assisted Umbilical Fascial Closure in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: video-assisted umbilical closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above 18 years symptomatic cholelithiasis Exclusion Criteria: acute cholecystitis age under 18 years previous umbilical hernia repair pre-existing umbilical hernia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard umbilical trocar incision closure (UC)<br>standard umbilical trocar incision closure | Procedure: video-assisted umbilical closure<br>* video-assisted umbilical closure<br>* Other names: standard umbilical fascial closure;|
| Active Comparator: Video-assisted umbilical trocar incision closure (UCVA))<br>video-assisted umbilical trocar incision closure | Procedure: video-assisted umbilical closure<br>* video-assisted umbilical closure<br>* Other names: standard umbilical fascial closure;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic cholecystectomy, pain, trocar site hernia