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Completed

NCT Number: NCT01018524

Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias

The purpose of this study is to:

1. compare the long term results of mesh versus suture repair in treatment of abdominal wall defects; 2. find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Surgery Univ. of Pecs

Pécs, 7624, Hungary

About this study

To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
  • All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
  • For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.

Exclusion criteria

  • Ages fewer than 18 or above 70 years
  • Hernia orifice under 5 cm2.
  • Planned or accidental intraoperative opening of any bowel.
  • Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
  • Severe renal or hepatic failure
  • Advanced stage of tumours or currently treated malignancies.
  • Inflamed or muddy content of hernia sac.
  • If the patient did not signed the consent form.

Treatment and study plan

Abdominal wall reconstruction

Procedure

suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate

Primary outcomes

  1. recurrence rate after hernia surgery

    Time frame: 5 years

Secondary outcomes

  1. chronic pain after hernia surgery

    Time frame: more one year

  2. complications after hernia surgery

    Time frame: 0-5 years

Sponsors and collaborators

Lead sponsor

Hungarian Surgical Society

Network

Registry information

Official study title

Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)

Acronym: HSS-AHS

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Nov 23, 2009
Registry last updated
Mar 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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