NCT04254237

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

3.1 years

First QC Date

February 1, 2020

Last Update Submit

September 3, 2023

Conditions

Incisional HerniaCholecystectomy, Laparoscopic

Keywords

Trocar site herniaLaparoscopyLaparoscopic cholecystectomyMinimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • Trocar site hernia

    Number of patients presenting a trocar site hernia, at the periumbilical incision, one year after laparoscopic cholecystectomy.

    One year

Secondary Outcomes (9)

  • Umbilical wound complications different from Trocar Site Hernia

    24 hours, 7 days, 30 days, 6 months and 1 year.

  • Non-umbilical wounds complications

    24 hours, 7 days, 30 days, 6 months and 1 year.

  • Other complications

    24 hours, 7 days, 30 days, 6 months and 1 year.

  • Surgical time

    Day 0

  • Conversion

    Day 0

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Infraumbilical Hasson trocar incision.

Procedure: Infraumbilical Hasson trocar incision

Control group

SHAM COMPARATOR

Supraumbilical Hasson trocar incision.

Procedure: Supraumbilical Hasson trocar incision

Interventions

Infraumbilical Hasson trocar incisionPROCEDURE

Infraumbilical Hasson trocar incision

Intervention group
Supraumbilical Hasson trocar incisionPROCEDURE

Supraumbilical Hasson trocar incision

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

La Mancha Centro General Hospital

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Tomelloso General Hospital

Tomelloso, Ciudad Real, 13700, Spain

Location

Valdepeñas General Hospital

Valdepeñas, Ciudad Real, 13300, Spain

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Antonio Morandeira-Rivas, MD PhD

    La Mancha Centro General Hospital

    PRINCIPAL INVESTIGATOR

  • Carlos Moreno Sanz, MD PhD FACS

    La Mancha Centro General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon and Residency program director

Study Record Dates

First Submitted

February 1, 2020

First Posted

February 5, 2020

Study Start

February 6, 2020

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations

ES(3)