Trocar Site Hernia After Laparoscopic Cholecystectomy, Supra Versus Infraumbilical Incision for Umbilical Trocar Entry (HOT)

Trocar Site Hernia After Laparoscopic Cholecystectomy: Randomized Clinical Trial Comparing Supra Versus Infraumbilical Incision for Umbilical Trocar Entry

Trocar site hernia is a specific complication of laparoscopic surgery. The increasingly frequent use of the laparoscopic approach has resulted in an increase in the number of hernias, mainly at the umbilical area. The appearance of a trocar site hernia can cause complications in the short and long term to the patient who may end up needing a reoperation.

In this study we want to compare the supraumbilical versus the infraumbilical location of the laparoscopy entry trocar, in terms of incisional hernia incidence.

Study Overview

• Status: Completed
• Conditions: Cholecystectomy, Laparoscopic; Incisional Hernia
• Intervention / Treatment: Procedure: Infraumbilical Hasson trocar incision; Procedure: Supraumbilical Hasson trocar incision

Detailed Description

Trocar site hernias have been considered as an underestimated problem by some surgeons. It's incidence varies in the literature between studies, which may be related to an insufficient diagnosis due to poor clinical manifestation and / or the lack of long-term follow-up of patients in some studies.

There are many risk factors that have been related to the trocar site hernia development. On one side, the patient clinical factors as the age, presence of obesity, diabetes mellitus or the smoking habits. On the other side, some risk factors related to the surgical technique have been described, as the entry technique, the size and the locations of the trocars, the fascial closure, the duration of the surgery or the infection of the surgical wound.

Regarding the location of the trocars, it seems that the middle line has more risk of incisional hernia than the lateral areas in the abdomen. However, the trocar locations out of the middle line is not always possible, especially in certain surgeries as the laparoscopic cholecystectomy where it can be necessary an expansion of the incision for removing the specimen. In the concrete case of laparoscopic cholecystectomy, the belly is usually the most popular region for placing the first trocar. However, there is not much evidence about the influence of the most popular locations of the umbilical trocar incision (supra or infraumbilical) in the development of incisional hernias.

In the middle line, the infraumbilical region presents a great ability to adapt to pressure changes, as it physiologically occurs during the pregnancy. On the other side, while the primary hernias in the supraumbilical and umbilical region are common, these are not produced in the infraumbilical region. Besides, in anatomical studies of the linea alba, a higher thickness of the fibres in the infraumbilical region has been observed, along with a different spatial arrangement, predominating the transverse fibres in the infraumbilical region and the oblique ones in the supraumbilical region. Therefore, we hypothesize whether the infraumbilical location of the trocar in the midline, theoretically a more protected region, can reduce the incidence of trocar site hernia in our patients.

The aim of this study is to compare the incidence of the Hasson trocar site hernia between the supra and infraumbilical locations a year after surgery, in high risk patients for trocar site hernia subjected to elective laparoscopic cholecystectomy.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Ciudad Real
    • Alcázar de San Juan, Ciudad Real, Spain, 13600
      • La Mancha Centro General Hospital
    • Tomelloso, Ciudad Real, Spain, 13700
      • Tomelloso General Hospital
    • Valdepeñas, Ciudad Real, Spain, 13300
      • Valdepeñas General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years old.
• Ability to understand the trial information.
• Patients with symptomatic gallstones or polyps scheduled for laparoscopic cholecystectomy.
• Elective surgery.
• One year potential follow-up.

• Patients that experience one or more of the following Trocar Site Hernia risk factors:

  • Over 60 years old.
  • Obesity, defined as Body Mass Index (BMI) > 30 Kg/m2.
  • Diabetes mellitus (DM).
  • Bronchopathy: A diagnosed Chronic Obstructive Pulmonary Disease (COPD) or smokers of more than 25 cigarette packages/year.
• Accept to participate in the study and sign the informed consent.

Exclusion Criteria:

• Contraindication to conduct a laparoscopic cholecystectomy.
• Patients with previous open supramesocolic surgery.
• Patients with previous surgery that affects the umbilical region.
• Patients with umbilical hernia or history of umbilical hernia surgical correction.
• A greater than 30 cm xifo-umbilical distance.
• Extreme obesity (Body Mass Index > 50 kg/m2).
• Cancer patients or in immunosuppressive therapy.
• Connective tissue disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Infraumbilical Hasson trocar incision.	Procedure: Infraumbilical Hasson trocar incision; Infraumbilical Hasson trocar incision
Sham Comparator: Control group; Supraumbilical Hasson trocar incision.	Procedure: Supraumbilical Hasson trocar incision; Supraumbilical Hasson trocar incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trocar site hernia	Number of patients presenting a trocar site hernia, at the periumbilical incision, one year after laparoscopic cholecystectomy.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Umbilical wound complications different from Trocar Site Hernia	Infection, seroma or ecchymosis at the umbilical wound	24 hours, 7 days, 30 days, 6 months and 1 year.
Non-umbilical wounds complications	Hernia, infection, seroma, ecchymosis or evisceration at non-umbilical wounds.	24 hours, 7 days, 30 days, 6 months and 1 year.
Other complications	Other complications not related to the surgical wound	24 hours, 7 days, 30 days, 6 months and 1 year.
Surgical time	Measured in minutes from the first incision until the complete closure of the last surgical wound	Day 0
Conversion	Conversion rate to open surgery (yes/no).	Day 0
Hospital stay	Measured in hours from the surgery to the patient discharge.	Day 0
Postoperative pain	Measured using the Visual Analogue Scale (VAS), with a punctuation between 0 (no pain) and 10 (the worst conceivable pain).	24 hours and 7 days after surgery.
Perceived Quality of Life	Measured using the SF-36 questionnaire,	baseline, one month and a year after surgery.
Aesthetic result	Measured using the Visual Analogue Scale, with a punctuation between 0 (not at all satisfied) and 10 (maximum satisfaction).	Six months and a year of the surgery.

Collaborators and Investigators

• Sponsor: Complejo Hospitalario La Mancha Centro
• Investigators: Principal Investigator: Antonio Morandeira-Rivas, MD PhD, La Mancha Centro General Hospital; Study Chair: Carlos Moreno Sanz, MD PhD FACS, La Mancha Centro General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: February 1, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Minimally invasive surgery; Laparoscopy; Trocar site hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 99-b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No