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Hernia, VentralPhase 4GINCISHERNIANCT00625053

Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair

A Phase 4 study testing Laparoscopic repair and Open midline incisional hernia repair in people with Hernia, Ventral and Body Image, run by University Hospital, Geneva at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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%. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Laparoscopic repair and Open midline incisional hernia repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSwitzerland
Study dates
Apr 2008to Sep 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Presence of local or systemic infection
  • Life expectancy < 2 years
  • Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)
  • Morbid obesity (BMI over 40)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site, 1 recruiting
  • Geneva University Hospital, Department of Surgery, Visceral Surgery Division

    Geneva, 1211

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

    Ihsan INAN, M.D.

    Recruiting

Other trials in Switzerland

About this study

Official title: Abdominal Midline Incisional Hernia Repair and Functional Outcome: Randomized Controlled Trial to Compare Open and Laparoscopic Surgical

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.

Read the detailed description

Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Discomfort, pain, body image alteration and diminished quality of life influences functional well being. Alteration in pulmonary function, risk of visceral incarceration or cutaneous complications are potential medical complications. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%). Recurrence rate with prosthetic repair in published series vary from 4% to 29%. Different techniques for mesh placement and variety of mesh and fixation material explains this wide range of recurrence rate nevertheless, large series with standardized techniques report less than 4% of recurrence rates.

Laparoscopic repair for incisional hernia is first published in 1993. Following reported large personal series in recent years and evolution of adapted materiel, this technique gained popularity.

The main difference between open and laparoscopic techniques is the reconstruction of the abdominal wall. In all open techniques, abdominal wall is reconstructed (hernia edges brought together) with reinforcement of the abdominal wall by a mesh inserted onlay, sublay or inlay. In laparoscopic repair, the fascial defect is left in-situ but reinforced with a mesh, overlapping largely the edges of hernia.

Advocated advantages of laparoscopy are: less abdominal wall dissection (less surgical complications), tension-free mesh repair (no suturing), less postoperative pain, less respiratory complications, shorter hospital stay, faster return to professional activity. Disadvantages attributed to laparoscopic repair are the steep learning curve, high material cost, longer operation times and rare but serious complications.

Large series and meta analyses confirmed the value of laparoscopic repair as at least equal if not better compared with open repair. Most of the trials are focused on recurrence, complication rate, hospital stay and sick leave. Only recently, quality of life and pain started to be evaluated. No valuable data exists on chronic pain or persistent neuralgia, body image, cosmesis or neuroticism neither after open nor the laparoscopic repair.

Chronic pain or persistent neuralgia has been recognized as a complication after inguinal hernia repair but was reported in the 1980s as a rare and infrequent condition. Studies from the mid 1990s have reported a higher frequency, with up to 50% of patients reporting pain after hernia repair more than 1 year after surgery. Chronic pain after hernia repair can be disabling, with considerable impact on quality of life. The natural history of postoperative pain, including its prevalence, etiology, duration, associated disability and it's social and economical impact remain undefined.

We know from our experience in inguinal hernia that chronic pain needs to be investigated scrupulously to be identified. 20 to 27% chronic pain is associated to open repair in series without specific questionnaires. Overall frequency of chronic pain is higher in studies with specific measurements, where pain is the primary outcome of interest. Preoperative psychological state of patient (depression, dependencies, drug consumption etc.) or history of chronic pain with previous surgery or accident may be a predicting factor.

The definition of "chronic pain" by the International Association of the Study of Pain is "pain lasting for 3 months or more". There is no a consensus on neither in the definition, nor the severity grades of CSPOP in the literature. In our study chronic pain is defined as a minimal score > 4 using the quadruple visual analogue scale (VASQ) 3 months after procedure.

Somatic, and neuropathic chronic pain syndromes are described. Neuropathic pain usually develops in the sensory distribution of an injured nerve. Chronic residual neuralgia occurs as a result of surgical handing of sensory nerves. The nerve trauma can be due to partial or complete division, stretching, contusion, crushing, electrical damage, or sutures compression. Secondary nerve damage can occur due to irritation or compression by an adjacent inflammatory process such as granuloma. Neuropathic pain described as pulling, tugging, tearing, throbbing, stabbing, shooting, numbing, and dull. The onset of neuropathic pain is often delayed, occurring after a latent period of days to weeks. Pain is often aggravated by ambulation and sexual intercourse. Once chronic pain is installed, it does not change without a radical treatment. Preoperative psychological state of patient (Depression, dependencies, drug consumption etc.) or history of chronic pain with previous surgery or accident may be a predicting factor.

The definition of ''Body image'' is given as person's perception of, satisfaction with, and attitudes toward his or her body in general and to particular areas of the body. Little is known about the subjective feelings and cosmetic consequences of scarring in patients who undergo either conventional or laparoscopic abdominal surgery. Few data has been reported about body image in patients with cancer, particular after mutilating operations such as mastectomy. Three papers on ileocolectomy, proctectomy and live donor nephrectomy are published by Dutch groups, comparing laparoscopy and laparotomy. Body image in presence of an incisional hernia is certainly degraded before the surgery, unfortunately no baseline data exists to date. Therefore, an hypothetic, relative, significant improvement in body image by laparoscopic treatment compared to open repair needs to be evaluated.

The standard open technique in our institution has two declinations, the first technique is retromuscular sublay and the second, open onlay mesh repair. In both techniques the fascial defect is closed by suture repair with mesh reinforcement. Superiority of one of these techniques compared to another is not proved, properly done, both achieve low recurrence rates. Laparoscopic technique needs to meet widely accepted good-practice principles: complete adhesiolysis between abdominal wall and viscera, use of specific bilayer mesh (non adherent on the visceral surface), coverage of totality of the previous scar length with at least 5cm overlap, adequate fixation.

Being tested
Laparoscopic repair, Open midline incisional hernia repair
Keywords
Neuroticism, Hernia, ventral, Laparoscopy, Quality of life
Medical subject headings
Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic repairProcedure or surgery

    Also called TIP

    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.

  • Open midline incisional hernia repairProcedure or surgery

    Also called Stoppa-Rives

    • 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.
Study groups in NCT00625053
Study groupRoleWhat they receive
1ExperimentalLaparoscopic repair
Receives: Procedure: Laparoscopic repair
2Active comparatorOpen repair
Receives: Procedure: Open midline incisional hernia repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Preoperative, 10, 30, 90, 365 and 730 postoperative days

Secondary outcomes (5)
  1. Respiratory function

    Measured: Preoperative, 10, 90 and 365 postoperative days

  2. Influence of neuroticism on overall outcome

    Measured: Preoperative, 10, 30, 90, 365 and 730 postoperative days

  3. Postoperative surgical and medical complications

    Measured: Preoperative, 10, 30, 90, 365 and 730 postoperative days

  4. Overall cost analysis

    Measured: Two years after the operation

  5. Recurrence rate

    Measured: Two years after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionSep 2011 (estimated)
  4. Study completionSep 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00625053
Sponsor's protocol ID
06-293
Acronym
GINCISHERNIA
Status last verified
Apr 2008
First submitted
19 Feb 2008
Last updated
15 Apr 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Laparoscopic repair and Open midline incisional hernia repair in people with Hernia, Ventral and Body Image, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ihsan INAN, M.D. (+41223723311 ext. 6858149, ihsan.inan@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2008.

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