Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair

NCT00625053 | Unknown Phase 4

• 1 other identifier: 06-293
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Hernia, Ventral; Body Image; Respiratory Function Tests; Quality of Life; Laparoscopy

Keywords

Neuroticism; Hernia, ventral; Laparoscopy; Quality of life

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Respiratory function

  Preoperative, 10, 90 and 365 postoperative days

• Influence of neuroticism on overall outcome

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

• Postoperative surgical and medical complications

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

• Overall cost analysis

  Two years after the operation

• Recurrence rate

  Two years after the operation

Study Arms (2)

1

EXPERIMENTAL

Laparoscopic repair

Procedure: Laparoscopic repair

2

ACTIVE COMPARATOR

Open repair

Procedure: Open midline incisional hernia repair

Interventions

Laparoscopic repair PROCEDURE

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.

Also known as: TIP

1

Open midline incisional hernia repair PROCEDURE

* 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.

Also known as: Stoppa-Rives

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital, Department of Surgery, Visceral Surgery Division

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe MOREL, Prof.

  Geneva University Hospital, Departement of Surgery, Visceral Surgery Division

  STUDY CHAIR

• Ihsan INAN, M.D.

  Geneva University Hospital, Departement of Surgery, Visceral Surgery Division

  STUDY DIRECTOR

Central Study Contacts

Ihsan INAN, M.D.

CONTACT

+41223723311; ihsan.inan@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 15, 2008

Record last verified: 2008-04

Locations

CH (1)