Incisional Hernia Repair Long-term Outcomes

Incisional Hernia Clinical Trial

Official title:

Long-term Outcomes and Quality of Life of Incisional Ventral Hernia Repair by Open or Laparoscopy Surgery: Randomized Clinical Trial Extension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192838
• Other study ID #: IH/AV/2017
• Status: Completed
• Phase: N/A
• Start date: February 24, 2003
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 31, 2020
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• Laparoscopic incisional ventral hernia repair
Laparoscopic repair of incisional ventral hernias (5-15 cm) with adouble-layer polypropylene- expanded polytetrafluoroethylene (ePTFE) mesh.
• Open incisional ventral hernia repair
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.

Locations

Country	Name	City	State
Spain	Francesc de Borja Hospital	Gandia	Valencia
Spain	Arnau de Vilanova Hospital	Valencia
Spain	Lluis Alcanyis Hospital	Xàtiva	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Salvador Peiro

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Asencio F, Aguiló J, Peiró S, Carbó 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of deaths	Death for any cause	10-15 years
Primary	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.	10-15 years
Secondary	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.	10-15 years
Secondary	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	10-15 years
Secondary	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.	10-15 years