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Prospective Evaluation of Laparoscopic and Open Incisional Hernia Repair: a Multicenter Cohort Study

Prospective Evaluation of Laparoscopic and Open Hernia Repair: a Multicenter Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01280370
Acronym
IHR_SALTC
Enrollment
371
Registered
2011-01-20
Start date
2010-09-30
Completion date
2018-07-31
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia Repair

Keywords

Incisional hernia repair

Brief summary

Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study. With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure. Hypothesis: Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to open incisional hernia repair.

Detailed description

Background Incisional hernia is a common long-term complication following abdominal surgery and is estimated to occur in 11-23% 1-3. Incisional hernia can be repaired by an open or by a laparoscopic approach. For incisional hernia prosthetic meshes are nowadays implanted for virtually all open and laparoscopic procedures. The use of laparoscopy for the treatment of incisional hernia was first reported in 1993 by LeBlanc and Booth 4. Short term follow-up studies show that laparoscopic surgery is associated with decreased postoperative pain, reduced risks of surgical site infections due to minimal tissue dissection, a shorter length of hospital stay and a shorter overall recovery period 5-9. Important long- term outcome parameters are recurrence rate and chronic pain 10,11. Recurrence after incisional hernia repair varies widely and ranges from 1% to 35% 1,3. Morbid obesity, a previous failed open repair, large defect size and postoperative complications are associated with an increased risk for recurrence 12. Heterogeneity of hernia size and follow-up further complicate comparison of the recurrence rate between different techniques. On average, 74% of recurrences occur within the first 3 years after initial repair 13. Series with an acceptable follow-up of at least 24 months report a recurrence rate in open and laparoscopic repair of approximately 10% 1. Currently, no well designed prospective study is available comparing the incidence of recurrence between open and laparoscopic incisional hernia repair. Such variability of patients characteristics, surgical techniques and surgical skills are likely to confound a prospective randomized trial. Consequently, a cohort study is performed allowing each surgeon to perform the technique he is most familiar with. The aim of this multicenter cohort study is to assess the incidence of recurrence 36 months after open and laparoscopic incisional hernia repair, performed in swiss hospitals. Objective All patients undergoing elective incisional hernia repair who meet the inclusion criteria (see below) are eligible for inclusion into the study. These patients will be informed about the details of the study preoperatively. After a patient has agreed to enroll into the study and has signed written informed consent, he/she will be advised to attend follow-up assessments according to the study plan. Methods All patients undergoing elective incisional hernia repair who meet the inclusion criteria (see below) are eligible for inclusion into the study. These patients will be informed about the details of the study preoperatively. After a patient has agreed to enroll into the study and has signed written informed consent, he/she will be advised to attend follow-up assessments according to the study plan.

Interventions

PROCEDUREAbdominal surgery

intraoperative mesh implantation

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients over 18 years old * Written informed consent * Primary or recurrent incisional hernia

Exclusion criteria

* Systemic or severe local infections * Emergency procedures

Design outcomes

Primary

MeasureTime frame
recurrence rate36 months

Secondary

MeasureTime frame
chronic pain36 months
length of hospital stay3 months
surgical site infections36 months
cosmetic results36 months
rigidity of the abdominal wall36 months
morbidity3 months

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026