NCT03255239

Brief Summary

Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

Same day

First QC Date

August 15, 2017

Last Update Submit

August 22, 2017

Conditions

Ventral HerniaVentral Incisional HerniaUmbilical Hernia

Keywords

ventral herniaOpen mesh repairPolyester meshPreperitonealRetromuscular

Outcome Measures

Primary Outcomes (1)

  • Recurrence rates

    Late complications of ventral hernia repair

    One year

Secondary Outcomes (3)

  • Operating time

    15 to 90 minutes

  • Early complication

    30 days

  • Postoperative pain

    6, 12 and 24 hours

Study Arms (3)

Preperitoneal mesh repair

EXPERIMENTAL

Ventral hernia repair using polyester preperitoneal mesh repair

Procedure: Ventral hernia repair

Retromuscular mesh repair

EXPERIMENTAL

Ventral hernia repair using polyester retromuscular mesh repair

Procedure: Ventral hernia repair

Suture repair

EXPERIMENTAL

Ventral hernia repair using suture repair

Procedure: Ventral hernia repair

Interventions

Ventral hernia repairPROCEDURE

Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.

Also known as: retromuscular mesh repair, preperitoneal mesh repair, suture hernia repair
Preperitoneal mesh repairRetromuscular mesh repairSuture repair

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vebtral hernia or post incisional hernia diameter \< 3 cm
  • Male or female aged between 18 and 90 year-old
  • Elective surgery for ventral hernia

You may not qualify if:

  • Any contraindication to the prosthetic treatment.
  • Any hernia or incisional hernia with a collar strictly greater than 3 cm.
  • Previous hernia mesh repaired
  • contraindication for general anaesthesia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taher Sfar Hospital

Mahdia, 5100, Tunisia

RECRUITING

MeSH Terms

Conditions

Hernia, VentralHernia, Umbilical

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Moez Boudokhane, MD

CONTACT

98461511Moez-chir@yahoo.fr

Mohamed Ali Chaouch, RD

CONTACT

26205105Docmedalichaouch@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of general surgery

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 21, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2017

Study Completion

December 31, 2019

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

TU(1)