Trocar Site Incisional Hernia Prevention

NCT04699201 | Recruiting

• 1 other identifier: 156/2020
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery. Methods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months. An ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination. Relevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique. There are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.

Conditions

Incisional Hernia

Keywords

Incisional Hernia, Umbilical Trocar, Preventive mesh

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia

  The primary endpoint is the incidence of incisional hernia in the 2 groups. Because incisional hernia may occur within the first months after surgery, assessment will be carried out during scheduled clinical visits over 12 months. The presence of incisional hernia will be evaluated by physical examination and radiologically by an abdominal US scan performed at the end of follow-up (12 months after operation).

  12 months

Secondary Outcomes (2)

• Perioperative complications

  30 days

• Economical impact

  12 months

Study Arms (2)

Prosthesis

EXPERIMENTAL

Firstly, a laparoscopic cholecystectomy is performed. After suturing the aponeurosis with a J needle and 0 Polydioxanone, a lightweight, large-pore mesh made of PVDF monofilament (polyvinylidene fluoride - DynaMesh-CICAT, FEC Textiltechnik, Germany) will be placed onlay, overlapping 2cm in all directions from the edge of the aponeurosis incision at the umbilical trocar site. The mesh will be fixed to the aponeurosis with cyanoacrylate glue (Glubran®, GEM, Viareggio, Italy).

Procedure: Hincisional hernia prevention by onlay prosthesis trocar closure; Procedure: laparoscopic cholecystectomy; Diagnostic Test: Abdominal ultrasound

Control

ACTIVE COMPARATOR

Firstly, a laparoscopic cholecystectomy is performed. Closure of the aponeurosis will be performed by standard procedure: under direct vision, suturing the aponeurosis with a J needle and 0 Polydioxanone, with a stitch interval of ≤ 5mm.

Procedure: laparoscopic cholecystectomy; Diagnostic Test: Abdominal ultrasound

Interventions

Hincisional hernia prevention by onlay prosthesis trocar closure PROCEDURE

Hincisional hernia prevention by onlay prosthesis trocar closure

Prosthesis

laparoscopic cholecystectomy PROCEDURE

Laparoscopic cholecystectomy with or without common bile duct exploration

Control; Prosthesis

Abdominal ultrasound DIAGNOSTIC_TEST

Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery

Control; Prosthesis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct, undergoing surgery in our hospital
• ASA (American Society of Anesthesiologists) \<IV

You may not qualify if:

• Allergy or intolerance to any of the mesh components
• Patients presenting already primary or incisional hernia of the abdominal wall
• ASA ≥IV
• Intraoperative conversion to laparotomy
• Emergency surgery
• Pregnancy

Sponsors & Collaborators

• Hospital Universitari Joan XXIII de Tarragona.: lead
• Institut de Diagnostic per la Imatge: collaborator
• Institut Investigacio Sanitaria Pere Virgili: collaborator

Study Sites (2)

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Tarragona, 43005, Spain

RECRUITING

Pius, Hospital de Valls

Valls, Tarragona, 43800, Spain

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Carles Olona Casas, MD

  Hospital Universitari de Tarragona

  STUDY DIRECTOR

Central Study Contacts

Joan Ferreres Serafini, MD

CONTACT

(+34) 657920793; joanfs8@gmail.com

Rosa Jorba Martin, MD

CONTACT

rjorba.hj23.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not know if the umbilical incision has been close by standard technique or with the preventive mesh. Also the radiologists performing the ultrasounds after 12 months will not have the information of Prosthesis/Control patient allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, 3rd year resident, General Surgery

Model Details: Bicentric Randomized Controlled Trial. 2 allocation groups, parallel. Single blind. Enrollment: consecutive cases Time Perspective: Prospective

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: March 2, 2021
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)