NCT00970515

Brief Summary

The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

September 1, 2009

Last Update Submit

June 14, 2021

Conditions

Incisional HerniaUmbilical Hernia

Keywords

LaparoscopyIncisional herniaUmbilical herniaMesh repairPostoperative complications

Outcome Measures

Primary Outcomes (2)

  • Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis

    2 months

  • Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage

    2 months

Secondary Outcomes (13)

  • Postoperative pain: measured by a- Visual Analogic Score (VAS 0-10): 1-number of days with VAS > 5; 2- maximal VAS, and b- duration (days) of morphine use

    2 months

  • Postoperative fever > 38°5

    2 months

  • Postoperative ileus

    2 months

  • Postoperative phlebitis

    2 months

  • Postoperative pulmonary embolism

    2 months

  • +8 more secondary outcomes

Study Arms (2)

Laparoscopic approach

EXPERIMENTAL

group A: Laparoscopic approach

Procedure: Laparoscopic mesh hernia repair

Open approach

ACTIVE COMPARATOR

group B: Open anterior approach

Procedure: Open anterior approach

Interventions

Laparoscopic mesh hernia repairPROCEDURE

The mesh is intraperitoneal

Also known as: laparoscpic mesh repair of incisional and umbilical hernia
Laparoscopic approach
Open anterior approachPROCEDURE

The mesh is placed by an anterior approach. It is placed after incision of the skin over or under the abdominal muscles, or is intraperitoneal

Also known as: Conventional treatment of incisional and umbilical hernia
Open approach

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter

You may not qualify if:

  • Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication
  • Patients with a recurrence of incisional hernia
  • Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible
  • Pregnant women
  • Patients with HIV therapy
  • Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin\> 35 micromol / l; TP \< 55%) or significant thrombocytopenia (\< 60 000 platelets)
  • Patients with a contra indication for laparoscopy
  • Patients with a life expectancy \< one year, or whose mobility within two years of treatment will damage proper monitoring
  • Patients unable to understand information about the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jean Verdier, department of digestive and general surgery

Bondy, 93140, France

Location

Related Publications (3)

  • Slim K, Vons C. [Inguinal hernia repair: results of randomized clinical trials and meta-analyses]. J Chir (Paris). 2008 Mar-Apr;145(2):122-5. doi: 10.1016/s0021-7697(08)73720-7. French.

    PMID: 18645551BACKGROUND

  • Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):366-70. doi: 10.1016/s0021-7697(04)95361-6. No abstract available. French.

    PMID: 15738845BACKGROUND

  • Proske JM, Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):360-4. doi: 10.1016/s0021-7697(04)95360-4. French.

    PMID: 15738844BACKGROUND

MeSH Terms

Conditions

Incisional HerniaHernia, UmbilicalPostoperative Complications

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic ProcessesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, Abdominal

Study Officials

  • Corinne Ms Vons, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2013

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

FR(1)