Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair (GINCISHERNIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00625053
First received: February 19, 2008
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abdominal Midline Incisional Hernia Repair and Functional Outcome: Randomized Controlled Trial to Compare Open and Laparoscopic Surgical

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Respiratory function [ Time Frame: Preoperative, 10, 90 and 365 postoperative days ] [ Designated as safety issue: No ]
  • Influence of neuroticism on overall outcome [ Time Frame: Preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]
  • Postoperative surgical and medical complications [ Time Frame: Preoperative, 10, 30, 90, 365 and 730 postoperative days ] [ Designated as safety issue: No ]
  • Overall cost analysis [ Time Frame: Two years after the operation ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: Two years after the operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Laparoscopic repair
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
Open repair
Procedure: Open midline incisional hernia repair
  • Underlay retromuscular repair: Medial border of the anterior fascia opened, posterior aspect of rectus muscle dissected to reach lateral border of rectus sheet, bilaterally. Peritoneum and posterior rectus fascia closed with absorbable running suture. Polyester or light-weight polypropylene mesh is cut to fit the reconstructed area, to have 3cm overlap on caudal and cranial defect limits. Mesh is fixed by absorbable sutures. Anterior fascia is closed with absorbable running suture. Components separation upon need.
  • Intraperitoneal onlay repair: Mesh is inserted intraperitoneally and fixed by a complete running suture (optional fixation with helicoidal pins or stapler). Fascial defect is closed with interrupted or running absorbable suture. Components separation upon need.
Other Name: Stoppa-Rives

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Age 18 years or older
  • Diagnosis of reducible incisional hernias up to 200 cm²
  • Medically fit for general anesthesia
  • Comprehension and use of French language
  • Installed in the geographical region without foreseeable move for two years

Exclusion Criteria:

  • Incarcerated hernia
  • Ongoing chronic pain syndrome, other than hernia origin
  • Coagulation disorders, prophylactic or therapeutic anticoagulation, unable to stop platelet antiaggregation therapy 10 days before surgery
  • American Society of Anesthesiology Class 4 and 5 patients
  • Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation
  • Mentally ill patients
  • Presence of local or systemic infection
  • Life expectancy < 2 years
  • Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)
  • Morbid obesity (BMI over 40)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625053

Contacts
Contact: Ihsan INAN, M.D. +41223723311 ext 6858149 ihsan.inan@hcuge.ch

Locations
Switzerland
Geneva University Hospital, Department of Surgery, Visceral Surgery Division Recruiting
Geneva, Switzerland, 1211
Contact: Ihsan INAN, M.D.    +41223723311 ext 6858149    ihsan.inan@hcuge.ch   
Principal Investigator: Ihsan INAN, M.D.         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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
  More Information

No publications provided

Responsible Party: Ihsan INAN M.D., Geneva University Hospital, Department of Surgery, Visceral Surgery Division
ClinicalTrials.gov Identifier: NCT00625053     History of Changes
Other Study ID Numbers: 06-293
Study First Received: February 19, 2008
Last Updated: April 10, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Neuroticism
Hernia, ventral
Laparoscopy
Quality of life

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on October 01, 2014