Incisional Hernia Clinical Trial
— HOTOfficial title:
Trocar Site Hernia After Laparoscopic Cholecystectomy: Randomized Clinical Trial Comparing Supra Versus Infraumbilical Incision for Umbilical Trocar Entry
NCT number | NCT04254237 |
Other study ID # | 99-B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 6, 2020 |
Est. completion date | March 30, 2023 |
Verified date | September 2023 |
Source | Complejo Hospitalario La Mancha Centro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | March 30, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | La Mancha Centro General Hospital | Alcázar de San Juan | Ciudad Real |
Spain | Tomelloso General Hospital | Tomelloso | Ciudad Real |
Spain | Valdepeñas General Hospital | Valdepeñas | Ciudad Real |
Lead Sponsor | Collaborator |
---|---|
Complejo Hospitalario La Mancha Centro |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trocar site hernia | Number of patients presenting a trocar site hernia, at the periumbilical incision, one year after laparoscopic cholecystectomy. | One year | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | Other complications | Other complications not related to the surgical wound | 24 hours, 7 days, 30 days, 6 months and 1 year. | |
Secondary | Surgical time | Measured in minutes from the first incision until the complete closure of the last surgical wound | Day 0 | |
Secondary | Conversion | Conversion rate to open surgery (yes/no). | Day 0 | |
Secondary | Hospital stay | Measured in hours from the surgery to the patient discharge. | Day 0 | |
Secondary | 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. | |
Secondary | Perceived Quality of Life | Measured using the SF-36 questionnaire, | baseline, one month and a year after surgery. | |
Secondary | 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. |
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 |