AzTrials
AzTrials

Inguinal HerniaPhase 4GENINGHERNIANCT00625534

Functional Outcome After Groin Hernia Mesh Repair: Open Versus Laparoscopy

A Phase 4 study testing Laparoscopic totally extraperitoneal inguinal hernia repair and Open tension free inguinal hernia mesh repair in people with Inguinal Hernia and Laparoscopic Surgery, 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion for hernia repair anymore. Read more about this study

Who is it for?
Ages 21 to 70 years, men only
Conditions the study is for
Inguinal Hernia, Laparoscopic Surgery, Pain
What is being tested?
Laparoscopic totally extraperitoneal inguinal hernia repair and Open tension free inguinal hernia mesh repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteSwitzerland
Study dates
Apr 2008to Apr 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 21 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent
  • Diagnosis of primary, unilateral or bilateral, reducible groin hernias
  • 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

  • Female gender, recurrent hernia
  • Ongoing chronic pain syndrome, other than hernia origin
  • Coagulation disorders, prophylactic or therapeutic anticoagulation, un able to stop platelet antiaggregation therapy 10 days before surgery
  • Previous pelvic surgical procedures contraindicating laparoscopic technique
  • American Society of Anesthesiology Class 4 and 5 patients
  • Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation
Show all 10Show fewer
  • Mentally ill patients
  • Presence of local or systemic infection
  • Life expectancy < 2 years
  • Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)

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.

    Recruiting

Other trials in Switzerland

About this study

Official title: Chronic Significant Pain and Functional Outcome After Laparoscopic Versus Open Groin Hernia Mesh Repair: Design of a Randomized Controlled Clinical Trial

Background: Large acceptance of mesh reinforcement techniques in groin hernia repair lowered recurrence rates for all techniques. Recurrence rate alone is not the main quality criterion for hernia repair anymore. Chronic significant post operative pain is a common, clinically relevant, poorly understood and poorly studied entity which is 3 to 5 times more common than hernia recurrence. As a subgroup to chronic significant post operative pain or as a separate entity, sexual dysfunction due to ejaculatory and genital pain after inguinal hernia repair may happen in approximately 2.5% of patients. Patient's preoperative psychological profile as well as pain exposure history is showed to be important in the development of chronic significant post operative pain. The objective of this study is to analyse chronic significant post operative pain and the functional outcome status of patients after laparoscopic repair compared to open repair.

Methods: A randomized controlled non-blinded clinical trial is designed to compare open inguinal hernia mesh repair with laparoscopic totally extraperitoneal repair on chronic significant post operative pain, pain related sexual function disorders, complications, health related quality of life outcomes, 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 21 years, with reducible inguinal unilateral or bilateral primary hernia who are candidates for elective surgery and medically fit for general anesthesia.130 patients will be enrolled for each group to achieve an α-Level of 0.05 and a power of 80%. 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 may 2009.

Read the detailed description

Hernia repair is the most frequent elective operation performed in general surgery. 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.

The Cooperative Hernia Study (1996) assessing postoperative pain in a prospective trial including 315 open non-mesh repair patients with 2 years follow-up found at 1 year, 62.9% of groin or inguinal pain and 11.9% of patients had moderate to severe pain; 53.6% had pain and 10.6% of patients continued to report moderate to severe pain 2 years postoperatively.

In a prospective consecutive case series study of 500 consecutive operations in 466 unselected adult patients for open groin hernia repair in Denmark (1994-1996), 1 year after surgery, 19% of patients had some degree of pain, 6% had moderate or severe pain. Pain restricted daily function 6% of patients.

A cross-sectional cohort study based on the Danish Hernia Database (1998) to determine the incidence of groin pain 1 year after inguinal hernia repair and to assess the influence of chronic groin pain on function, detected 28.7% of pain in the groin area and 11.0% of the patients reported that pain was interfering with work or leisure activity. There were no difference in the incidence of pain with regard to the different types of hernia, the different types of surgical repairs, or the different types of anesthesia.

A questionnaire survey of a historical cohort of 351 patients who underwent inguinal hernia surgery in Aberdeen - Scotland (1995-1997) reported 30% chronic pain. Character of this pain was predominantly neuropathic.

Definition of chronic pain 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 consensus on neither in the definition, nor the severity grades of CSPOP in the literature. In the Cooperative Hernia Study, Cunningham et al. clearly described mild, moderate, and severe pain. Mild pain was defined as an occasional pain or discomfort that did not limit activity, with a return to lifestyle before hernia; moderate pain, as pain preventing return to normal preoperative activities (i.e., inability to continue with activities before hernia such as golf, tennis, or other sports, and inability to lift objects without pain, that patients had been lifting before the hernia occurrence); and severe pain, as pain that incapacitated the patient at frequent intervals or interfered with activities of daily living (i.e., a pain constantly present, or intermittently present but so severe as to impair normal activities, such as walking). Other studies defined chronic pain as "that persisting for one year postoperatively". One Dutch study defined pain as pain in the groin or scrotum lasting more than 1 month after surgery. In our study chronic pain is defined as a minimal score > 4 using the quadruple visual analogue scale (VASQ) 3 months after procedure.

Characteristics and etiology of chronic pain Somatic, neuropathic, and visceral chronic pain syndromes are described. Cunningham et al. reported the somatic pain syndrome as the most common type of chronic post hernia pain. The pain is localized to common ligamentous insertion to the pubic tubercle. Somatic pain may be due to the damage to the pubic tubercle during the stapling of mesh prosthesis or from deep muscle layers. Incorporation of the periosteum of the pubic tubercle into the most medial suture during open hernia repair is accused. Neuropathic pain is probably attributable to damage to the ilioinguinal or genitofemoral nerve. 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, stooping or hyperextension of hip and sexual intercourse; and alleviated by recumbent position and flexion of the hip and thigh. In laparoscopic hernia repair when stapling the mesh, it can penetrate the wall of the inguinal canal entrapping and irritating the sensory nerves. Kinking of the nerves may cause chronic irritation. The third pain syndrome described in the literature is visceral. For example, pain encountered only on ejaculation due to dysfunction of periurethral structures involved in ejaculation. One possible mechanism is the injury to either somatic sacral or sympathetic nerves, resulting in dyssynergia of the ejaculatory effector muscles. It can also be due to stricture in the spermatic duct from the scar tissue or twisting of the cord.

Prognosis of chronic pain Once chronic pain is installed, it does not change without a radical treatment. Cunningham et al. reported a prevalence of mild, moderate, or severe pain of 63% at 1 year postoperatively, which was reduced to 54% after 2 years. Those patients who reported moderate to severe pain at 1 year (12%) continued to report persistent pain at 2 years (11 %).

Risk of developing chronic pain

  • Predisposing psychological factors 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.
  • Surgical factors Recurrent hernia, preoperative pain and absence of visible bulge before surgery, delayed onset of symptoms after surgery, high pain scores at one week postoperatively and requirement of four or more weeks before returning to work are reported as risk factors for developing of chronic pain.

Impact of surgical technique Several different surgical techniques are studied with each other in the literature and different meta analyses, each with different point of interest, gives different lectures of the reality. Despite the fact that there is no consensus in the literature, surgical technique is clearly one of the key parameters. The overall frequency of chronic pain is higher in studies with specific measurements, where pain is the primary outcome of interest.

  • OMR vs. non-mesh repair The hypothetical advantage of tension free repair on chronic pain issue is not confirmed. Two retrospective cohort studies coming from the tenors of open mesh repair, reported less chronic pain with mesh repair. This advantage of mesh repair on pain scores versus conventional no-mesh repairs is not confirmed by randomized controlled trials.
  • LR vs. OMR The only study comparing laparoscopic totally extraperitoneal (TEP) repair (Polypropylene mesh without fixation) with classic OMR (Lichtenstein) comes from Kumar et al. They find overall 30% of "chronic pain and discomfort" (22,5% for LR, 38,3% for OMR) after a mean of 21 months post hernia repair. Medical Research Council trial reported a significantly higher incidence of chronic pain after open repair than after laparoscopic repair (37 % versus 29 %) at 1 year. This trial, however, included non-mesh repairs in the open group and transabdominal preperitoneal (TAP) and TEP repairs in the laparoscopic group. In a meta-analysis of randomized controlled trials of laparoscopic and open prosthetic mesh repair of groin hernia, EU Trialists found that chronic pain is less likely to occur after laparoscopic repair than after open repair.
  • TEP or TAP? The TAP repair is historically the technique of choice in the north america. Most of the literature compares TAP to another technique. In this technique, flat, heavy weighted polypropylene meshes were used and fixed with staplers or tackers. Peritoneal tears were also closed with the same technique. Higher rates of chronic pain were reported after TAP repair versus TEP repair. Nerve entrapment during these several stapling procedures was probably the main reason. TAP is also strongly associated to "rare but serious vascular and visceral complications". The Medical Research Council trial reported that all serious complications occurred in patients undergoing the TAP approach. Most of the postoperative complications as sepsis on bowel fistula with mesh, mechanical ileus on adherences or port site hernias are seen in TAP repair. In our practice TEP repair is the technique of choice. Dissection is realized without the use of balloon dissector, an anatomic, preformed anatomic polyester mesh implanted without fixation by stapling, tacking or suture.
Being tested
Laparoscopic totally extraperitoneal inguinal hernia repair, Open tension free inguinal hernia mesh repair
Keywords
Hernia, Laparoscopy, Pain, Sexual, Quality
Medical subject headings
Hernia, Inguinal, Pain, Sexual Dysfunction, Physiological, Hernia, Coitus

What participants receive

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

  • Laparoscopic totally extraperitoneal inguinal hernia repairProcedure or surgery

    Also called TEP, Laparoscopic hernia repair

    3 trocars procedure. Blunt camera dissection without use of balloon dissector. Anatomical, preformed, polyester mesh passed around spermatic cord structures. No fixation of mesh.

  • Open tension free inguinal hernia mesh repairProcedure or surgery

    Also called Lichtenstein repair

    Classical Lichtenstein repair. Polyester flat 14x8cm mesh

Study groups in NCT00625534
Study groupRoleWhat they receive
1ExperimentalLaparoscopic repair
Receives: Procedure: Laparoscopic totally extraperitoneal inguinal hernia repair
2Active comparatorOpen tension free inguinal hernia mesh repair
Receives: Procedure: Open tension free inguinal hernia mesh repair

What is being measured

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

  1. Chronic significant post operative pain

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

Secondary outcomes (6)
  1. Pain related sexual function disorders

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

  2. Health related quality of life

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

  3. Neuroticism

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

  4. Postoperative surgical and medical complications

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

  5. Recurrence rate

    Measured: 730th postoperative day

  6. Overall cost analysis

    Measured: 730th postoperative day

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 completionApr 2011 (estimated)
  4. Study completionApr 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
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00625534
Sponsor's protocol ID
05-122
Acronym
GENINGHERNIA
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 totally extraperitoneal inguinal hernia repair and Open tension free inguinal hernia mesh repair in people with Inguinal Hernia and Laparoscopic Surgery, 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 5 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?

Chronic significant post operative pain (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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in