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OpenTrials
Completed

NCT Number: NCT01586741

A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

This is a three armed prospective randomized trial that will compare two different surgical techniques for reconstruction of the abdominal wall diastasis with a conservative treatment procedure.

The study hypothesis:

Which surgical approach provides the safest and best long term results for patients with abdominal wall diastasis either the insertion of net alternative with a double row suture or exercise alone?

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Key information

Conditions

Abdominal Hernias and Other Abdominal Wall Conditions Disease Attributes Hernia Hernia, Abdominal Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Recurrence Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clintec, Karolinska Institutet

Stockholm, 17176, Sweden

About this study

The conservative control group will receive a special training program for abdominal muscle training for 3 months,and all groups wearing girdle for 3 months.

All patients examined with a CT scan before randomization and then a Biodex measurement of abdominal muscle strength.

All patients must also complete the SF-36 (scientifically tested instruments to measure self-reported physical and mental health) and VHPQ (ventral hernia Pain Questionnaire).

Two-thirds of patients receive surgery and followed up with a 3 month and 1-year control.At 1 year of control, all go through a CT scan and a Biodex measurement of muscle strength.

The control group followed up after one and half months and 3 months. In the surgery group, patients may not know what reconstruction they received before the final assessment after 1 year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Abdominal wall diastasis> 3 cm
  • Discomfort or tenderness in the abdominal wall
  • Desire for abdominal wall reconstruction
  • Women have undergone at least one birth
  • Smoking cessation 1 month pre-and 3 months post-operatively

Exclusion criteria

  • <18 years old
  • Ongoing pregnancy
  • Ongoing breastfeeding
  • Current immunosuppressive therapy

Treatment and study plan

Quill suture application for repair or polypropylene mesh

Procedure

The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training

Other names: Quill suture, And Soft mesh Polypropylene mesh

Primary outcomes

  1. Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.

    Time frame: follow-up 1 year after surgery

    All patients go through a CT scan and clinical examination one year after surgery

Secondary outcomes

  1. Adverse Event Indicated in Case Report Formulary During the First 12 Months

    Time frame: follow-up 1 year after surgery

    adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection

  2. Pain Post Operatively Measured by the VHPQ Questionnaires

    Time frame: follow-up 1 year after surgery

    The validity and reliability of the VHPQ make it a useful tool in assessing postoperative pain and patient satisfaction.

    PMID:

    22446989 PubMed - as supplied by publisher

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Apr 27, 2012
Registry last updated
Dec 23, 2020

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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