Clinical trial NCT01280370: Prospective Evaluation of Laparoscopic and Open Incisional Hernia Repair: a Multicenter Cohort Study
Official title: Prospective Evaluation of Laparoscopic and Open Hernia Repair: a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia Repair
Keywords: Incisional hernia repair
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria

* Systemic or severe local infections
* Emergency procedures

Primary outcomes:
measure: recurrence rate
timeFrame: 36 months
Secondary outcomes:
measure: surgical site infections
timeFrame: 36 months
measure: chronic pain
timeFrame: 36 months
measure: length of hospital stay
timeFrame: 3 months
measure: morbidity
timeFrame: 3 months
measure: cosmetic results
timeFrame: 36 months
measure: rigidity of the abdominal wall
timeFrame: 36 months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Dep. of Visceral and transplant surgery, Berne University Hospital
Study officials:
affiliation: Berne, University Hospital, University of Berne, Switzerland
name: Guido Beldi, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: