Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair (GINCISHERNIA)
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|ClinicalTrials.gov Identifier: NCT00625053|
Recruitment Status : Unknown
Verified April 2008 by University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted : February 28, 2008
Last Update Posted : April 15, 2008
Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%). Use of prosthetic mesh in incisional hernia repair lowered the recurrence rates under 10%. Recurrence rate alone is not the main quality criterion for incisional hernia repair anymore. Large series and meta-analyses confirmed the value of laparoscopic repair as at least equal if not better compared with open repair. Discomfort, pain, diminished quality of life and body image alteration influences functional well being. No baseline information exists in any of these fields treating pre- or post-operative phases in patients with incisional hernia. Respiratory functions and medico-economic evaluation are other rarely investigated fields that we consider in our trial. The objective of this study is to analyse the functional outcome status of patients after laparoscopic incisional hernia repair compared to open repair.
Methods: A randomized controlled non-blinded clinical trial is designed to compare laparoscopic incisional hernia mesh repair with open repair on post operative pain, health related quality of life outcomes, body image and cosmetic measurements, respiratory functions, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 18 years, with reducible incisional hernia who are candidates for elective surgery and medically fit for general anesthesia.30 patients will be enrolled for each group. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in september 2009.
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Ventral Body Image Respiratory Function Tests Quality of Life Laparoscopy||Procedure: Laparoscopic repair Procedure: Open midline incisional hernia repair||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abdominal Midline Incisional Hernia Repair and Functional Outcome: Randomized Controlled Trial to Compare Open and Laparoscopic Surgical|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||September 2011|
Procedure: Laparoscopic repair
Complete adhesiolysis between viscera and abdominal wall, complete dissection of round ligament and subumbilical fatty tissue to expose the posterior fascia at least 5 cm further than the cranial and caudal limits of the fascial defect or the original incision. Overlap of minimum 5 cm is calculated and mesh inserted in the abdominal cavity through 12mm optical trocar. Fixation of a antiadhesive composite mesh with helicoidal pins with maximum 15mm interval, double crown technique. No pressure decrease maneuver is done during mesh fixation or at another time during the operation. No transparietal suture fixation. No fascial closure.
Other Name: TIP
Active Comparator: 2
Procedure: Open midline incisional hernia repair
Other Name: Stoppa-Rives
- Does Laparoscopic repair generate better functional outcome compared to the open mesh repair. Functional outcome includes pain, quality of life, body image and cosmetic measurements. [ Time Frame: Preoperative, 10, 30, 90, 365 and 730 postoperative days ]
- Respiratory function [ Time Frame: Preoperative, 10, 90 and 365 postoperative days ]
- Influence of neuroticism on overall outcome [ Time Frame: Preoperative, 10, 30, 90, 365 and 730 postoperative days ]
- Postoperative surgical and medical complications [ Time Frame: Preoperative, 10, 30, 90, 365 and 730 postoperative days ]
- Overall cost analysis [ Time Frame: Two years after the operation ]
- Recurrence rate [ Time Frame: Two years after the operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625053
|Contact: Ihsan INAN, M.D.||+41223723311 ext firstname.lastname@example.org|
|Geneva University Hospital, Department of Surgery, Visceral Surgery Division||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Ihsan INAN, M.D. +41223723311 ext 6858149 email@example.com|
|Principal Investigator: Ihsan INAN, M.D.|
|Study Chair:||Philippe MOREL, Prof.||Geneva University Hospital, Departement of Surgery, Visceral Surgery Division|
|Study Director:||Ihsan INAN, M.D.||Geneva University Hospital, Departement of Surgery, Visceral Surgery Division|