Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis

NCT ID: NCT03623594

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There is insufficient evidence regarding the benefit from surgical reconstruction of post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the abdominal trunk function preoperatively and postoperatively in a group of women undergoing surgery for abdominal rectus muscle diastasis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There is little evidence regarding the various treatment options of abdominal rectus muscle diastasis in post-partum women. The lack of evidence may, to a great extent, be explained by the lack of uniform criteria for assessing the trunk function and how the trunk function affects the ability to perform daily activities. To be able to evaluate the condition with symptomatic ARD a more comprehensive, multimodal instrument is therefore needed.

In collaboration with the surgical clinic and the physiotherapy clinic at Södersjukhuset a multimodal examination test was developed with the purpose to be able to evaluate the full picture of the condition.

The purpose of this study was to evaluate the effect of surgical reconstruction of post-partum abdominal rectus muscle diastasis in women with insufficient improvement after adequate physical training using a novel multimodal evaluation tool.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectus Abdominus; Diastasis, Complicating Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Repair of the abdominal rectus diastasis with a double row plication using absorbable Quill
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical repair of the diastasis

Repair of the diastasis with a double row plication using absorbable Quill suture

Group Type EXPERIMENTAL

Surgical repair of the diastasis

Intervention Type PROCEDURE

Repair of the diastasis with a double row plication using absorbable Quill suture

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical repair of the diastasis

Repair of the diastasis with a double row plication using absorbable Quill suture

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Non-smoking women
* BMI \<35
* Inter-recti distance \>3cm
* Lack of response to standardized core stabilizing training
* \>1 year since last partus
* No intention of further pregnancies

Exclusion Criteria

* Inability to quit smoking
* BMI \>35
* Inter-recti distance \<3cm
* \<1 year since last partus
* Further pregnancies not excluded
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gabriel Sandblom

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gabriel Sandblom, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteopathy of Post Cesarean Section Adhesions
NCT06907394 NOT_YET_RECRUITING NA