Clinical Trials Logo

Clinical Trial Summary

The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.

Patients will be randomized into 2 groups:

- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port

- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port.

Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.


Clinical Trial Description

The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.

Patients will be randomized into 2 groups:

- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port. Pneumoperitoneum will be done by this Hasson port.

- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. Pneumoperitoneum will be previously done using a Veress needle.

Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04347642
Study type Interventional
Source Hospital General Universitario Elche
Contact Jaime Ruiz-Tovar
Phone +34630534808
Email jruiztovar@gmail.com
Status Recruiting
Phase Phase 3
Start date July 7, 2020
Completion date September 15, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06016426 - Mass Closure vs Layer by Layer Closure N/A
Recruiting NCT05734222 - Optimization of Surgical Treatment of Patients With Incisional Ventral Hernias N/A
Enrolling by invitation NCT03105895 - Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI N/A
Completed NCT02089958 - Standardization of Laparoscopic Hernia Repair N/A
Completed NCT01961687 - A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair. N/A
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Terminated NCT00498810 - COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL) N/A
Completed NCT04961346 - RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair N/A
Terminated NCT03912662 - ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention N/A
Recruiting NCT05620121 - ACute Treatment of Incisional Ventral Hernia
Recruiting NCT03561727 - Risk Factors for Development of Incisional Hernia in Transverse Incisions N/A
Completed NCT03938688 - Randomized Control Trial Comparing Transfascial Suture for Mesh Fixation to No Mesh Fixation N/A
Not yet recruiting NCT05568238 - Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen N/A
Not yet recruiting NCT02896686 - Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure Phase 4
Recruiting NCT02277262 - PROPHYlactic Implantation of BIOlogic Mesh in Peritonitis (PROPHYBIOM) Phase 4
Active, not recruiting NCT02328352 - "BP as a New Device for Surgery and Solid Cancer and Hematopoietic System Tumors Treatment. Effects of BP Implantation" Phase 1/Phase 2
Suspended NCT01520168 - Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management N/A
Completed NCT05579652 - Change in Fascial Tension in Open Abdomens
Active, not recruiting NCT03390764 - Hernia After Colorectal Cancer Surgery N/A
Completed NCT02321059 - Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia N/A