Incisional Hernia Repair Long-term Outcomes
Primary Purpose
Incisional Hernia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Laparoscopic incisional ventral hernia repair
Open incisional ventral hernia repair
Sponsored by
About this trial
This is an interventional treatment trial for Incisional Hernia focused on measuring Incisional hernia, Laparoscopic surgery, Recurrence, Health Related Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Incisional hernia between 5 and 15 cm in largest diameter
- No ontraindication for laparoscopic surgery.
Exclusion Criteria:
- Patients with any type of stoma,
- Non-residente in the Valencia región
Sites / Locations
- Francesc de Borja Hospital
- Lluis Alcanyis Hospital
- Arnau de Vilanova Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LVHR
OVHR
Arm Description
Laparoscopic incisional ventral hernia repair
Open incisional ventral hernia repair
Outcomes
Primary Outcome Measures
Hernia recurrence
Rate of participants with hernia recurrence assessed by: 1) clinical evaluation during the first year of follow-up, taking advantage of the original RTC data, available for all patients in the study; 2) clinical evaluation, accompanied when necessary by an abdominal CT scan, carried out between 2017 and 2019 for living patients who accepted participation in the extension study; 3) review of the EMR, including available abdominal CT scans close to patients' death, for patients deceased prior to the clinical evaluation of the extension study.
Secondary Outcome Measures
Surgical repair of recurrent incisional hernia
Rate of participants with a hernia reoperation assessed by: 1) clinical evaluation during the first year of follow-up, taking advantage of the original RTC data, available for all patients in the study; 2) clinical evaluation carried out between 2017 and 2019 for living patients who accepted participation in the extension study; 3) review of the EMR for patients deceased prior to the clinical evaluation of the extension study.
Mesh related complications
Rate of participants with a reoperation for intestinal obstruction, or mesh extrusion, or intestinal fistulas, or adhesion syndrome treated conservatively. Only for intraperitoneal mesh
Health Related Quality of Life: EuraHS-QoL questionnaire
The EuraHS-QoL questionnaire was used for assessing HRQoL in living no reoperated patients who accepted participation in the clinical evaluation of the extension study. The EuraHS-QoL scale is a hernia specific HRQoL self-administered questionnaire with 9 items that can be scored by the patient in an 11-point scale (from 0 to 10). The total score ranges from 0-90, with the lower scores being the most favourable outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04192838
Brief Title
Incisional Hernia Repair Long-term Outcomes
Official Title
Long-term Outcomes and Quality of Life of Incisional Ventral Hernia Repair by Open or Laparoscopy Surgery: Randomized Clinical Trial Extension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 24, 2003 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Salvador Peiro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Long-term extension of a previous trial comparing outcomes after open (OVHR) or laparoscopic incisional ventral hernia repair (LVHR), assessing recurrence, reoperation, intraperitoneal mesh-related complications and self-reported quality-of-life with 10-15 years of follow-up.
Detailed Description
Long-term studies comparing outcomes after open (OVHR) or laparoscopic incisional ventral hernia repair (LVHR) are scarce. We carried-out a long-term extension of a previous trial comparing both approaches, assessing recurrence, reoperation, intraperitoneal mesh-related complications and self-reported quality-of-life with 10-15 years of follow-up.
Patients will be followed to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index surgery (between 2003 to 2006) until recurrence, death or study completion with a clinical revision (between 2017 to 2019) whichever was first. By intention to treat, incidence rates of recurrence, reintervention and death by 1000 person-year of follow-up will be estimated, and also rates of mesh complications by 1000 person-year for the LVHR group excluding conversions. Quality of life, using the European Hernia Society Quality of Life score (EuraHS-QoL), will be assessed for survivors no reoperated patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
Keywords
Incisional hernia, Laparoscopic surgery, Recurrence, Health Related Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LVHR
Arm Type
Experimental
Arm Description
Laparoscopic incisional ventral hernia repair
Arm Title
OVHR
Arm Type
Active Comparator
Arm Description
Open incisional ventral hernia repair
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic incisional ventral hernia repair
Intervention Description
Laparoscopic repair of incisional ventral hernias (5-15 cm) with adouble-layer polypropylene- expanded polytetrafluoroethylene (ePTFE) mesh.
Intervention Type
Procedure
Intervention Name(s)
Open incisional ventral hernia repair
Intervention Description
Standard polypropylene mesh was positioned as an inlay, or as an onlay over the external oblique fascia (i.e., subcutaneously), as preferred by the operating team. The mesh was fixed with absorbable stitches. Drains were usually placed.
Primary Outcome Measure Information:
Title
Hernia recurrence
Description
Rate of participants with hernia recurrence assessed by: 1) clinical evaluation during the first year of follow-up, taking advantage of the original RTC data, available for all patients in the study; 2) clinical evaluation, accompanied when necessary by an abdominal CT scan, carried out between 2017 and 2019 for living patients who accepted participation in the extension study; 3) review of the EMR, including available abdominal CT scans close to patients' death, for patients deceased prior to the clinical evaluation of the extension study.
Time Frame
10-15 years
Secondary Outcome Measure Information:
Title
Surgical repair of recurrent incisional hernia
Description
Rate of participants with a hernia reoperation assessed by: 1) clinical evaluation during the first year of follow-up, taking advantage of the original RTC data, available for all patients in the study; 2) clinical evaluation carried out between 2017 and 2019 for living patients who accepted participation in the extension study; 3) review of the EMR for patients deceased prior to the clinical evaluation of the extension study.
Time Frame
10-15 years
Title
Mesh related complications
Description
Rate of participants with a reoperation for intestinal obstruction, or mesh extrusion, or intestinal fistulas, or adhesion syndrome treated conservatively. Only for intraperitoneal mesh
Time Frame
10-15 years
Title
Health Related Quality of Life: EuraHS-QoL questionnaire
Description
The EuraHS-QoL questionnaire was used for assessing HRQoL in living no reoperated patients who accepted participation in the clinical evaluation of the extension study. The EuraHS-QoL scale is a hernia specific HRQoL self-administered questionnaire with 9 items that can be scored by the patient in an 11-point scale (from 0 to 10). The total score ranges from 0-90, with the lower scores being the most favourable outcome.
Time Frame
10-15 years
Other Pre-specified Outcome Measures:
Title
Rate of deaths
Description
Death for any cause
Time Frame
10-15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Incisional hernia between 5 and 15 cm in largest diameter
No ontraindication for laparoscopic surgery.
Exclusion Criteria:
Patients with any type of stoma,
Non-residente in the Valencia región
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Asencio-Arana, MD, PhD
Organizational Affiliation
Arnau de Vilanova University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Francesc de Borja Hospital
City
Gandia
State/Province
Valencia
ZIP/Postal Code
46702
Country
Spain
Facility Name
Lluis Alcanyis Hospital
City
Xàtiva
State/Province
Valencia
ZIP/Postal Code
46800
Country
Spain
Facility Name
Arnau de Vilanova Hospital
City
Valencia
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19116750
Citation
Asencio F, Aguilo J, Peiro S, Carbo J, Ferri R, Caro F, Ahmad M. Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc. 2009 Jul;23(7):1441-8. doi: 10.1007/s00464-008-0230-4. Epub 2008 Dec 31.
Results Reference
background
PubMed Identifier
34018042
Citation
Asencio F, Carbo J, Ferri R, Peiro S, Aguilo J, Torrijo I, Barber S, Canovas R, Andreu-Ballester JC. Laparoscopic Versus Open Incisional Hernia Repair: Long-Term Follow-up Results of a Randomized Clinical Trial. World J Surg. 2021 Sep;45(9):2734-2741. doi: 10.1007/s00268-021-06164-7. Epub 2021 May 20.
Results Reference
derived
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Incisional Hernia Repair Long-term Outcomes
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