NCT01586741

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

December 23, 2020

Completed
Last Updated

December 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

November 21, 2011

Results QC Date

November 25, 2020

Last Update Submit

November 25, 2020

Conditions

Abdominal Hernias and Other Abdominal Wall ConditionsPost-operative PainRecurrence

Outcome Measures

Primary Outcomes (1)

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

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

    follow-up 1 year after surgery

Secondary Outcomes (2)

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

    follow-up 1 year after surgery

  • Pain Post Operatively Measured by the VHPQ Questionnaires

    follow-up 1 year after surgery

Study Arms (3)

Polypropylene mesh

ACTIVE COMPARATOR

Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.

Procedure: Quill suture application for repair or polypropylene mesh

quill suture

ACTIVE COMPARATOR

Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients.

Procedure: Quill suture application for repair or polypropylene mesh

conservative treatment

NO INTERVENTION

Regular abdominal exercises workout for three months for 30 patients.

Interventions

Quill suture application for repair or polypropylene meshPROCEDURE

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

Also known as: Quill suture, And Soft mesh Polypropylene mesh
Polypropylene meshquill suture

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clintec, Karolinska Institutet

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Emanuelsson P, Gunnarsson U, Strigard K, Stark B. Early complications, pain, and quality of life after reconstructive surgery for abdominal rectus muscle diastasis: a 3-month follow-up. J Plast Reconstr Aesthet Surg. 2014 Aug;67(8):1082-8. doi: 10.1016/j.bjps.2014.04.015. Epub 2014 May 2.

    PMID: 24880577DERIVED

MeSH Terms

Conditions

Hernia, AbdominalPain, PostoperativeRecurrence

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Results Point of Contact

Title
D. Peter Emanuelsson
Organization
Karolinska University Hospital
peter.emanuelsson@sll.se
+46851770000

Study Officials

  • Ulf S Gunnarsson, professor

    Karolinska Institutet

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, consultant in plastic surgery

Study Record Dates

First Submitted

November 21, 2011

First Posted

April 27, 2012

Study Start

December 1, 2009

Primary Completion

November 1, 2011

Study Completion

December 1, 2012

Last Updated

December 23, 2020

Results First Posted

December 23, 2020

Record last verified: 2020-11

Locations

SE(1)