Trials / Unknown
UnknownNCT04347642
Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Hospital General Universitario Elche · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Umbilical port placement | The port will be inserted in the midline at the level of the umbilicus. |
| PROCEDURE | Paraumbilical port placement | The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus. |
Timeline
- Start date
- 2020-07-07
- Primary completion
- 2021-09-15
- Completion
- 2021-09-15
- First posted
- 2020-04-15
- Last updated
- 2020-07-09
Locations
2 sites across 2 countries: Mexico, Spain
Source: ClinicalTrials.gov record NCT04347642. Inclusion in this directory is not an endorsement.