Abdominal Rectus Diastasis (ARD) Reconstruction

Rectus Diastasis Clinical Trial

— ARD  

Official title:

Minimally Invasive Abdominal Wall Reconstruction in Symptomatic Rectus Diastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182412
• Other study ID #: 2019-01959
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Anders Thorell, Professor
• Phone: +46 8 714 6541
• Email: anders.thorell[@]erstadiakoni.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether abdominal wall reconstruction through laparoscopic surgery can be recommended as a safe treatment alternative for patients with symptomatic rectus diastasis, and if this type of treatment leads to improved quality of life, trunk stability and reduced pain.

Description:

Investigate whether surgical reconstruction with laparoscopic technique can lead to improved quality of Life, trunk stability and reduced pain in patients with symptomatic rectus diastasis. The study will also compare two different laparoscopic surgery methods for abdominal wall reconstruction: narrowing of linea alba with continuous suture with or without mesh.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Rectus diastasis =3 cm

• BMI =<28 kg/m2

• non smoker

• abdominal instability,

• abdominal wall and/or lower back pain despite physical therapy / structured physical exercise for at least 6 months

Exclusion Criteria:

• BMI >28 kg/m2

• Smoking

• Ongoing immunosuppressive therapy

• Current pregnancy =16 weeks gestational age for the last 12 months

• Pregnant or women who wish to become pregnant

• Previously extensive abdominal wall surgery incl hernia surgery (NOT including sectio, appendectomy, small umbilical herniae)

Related Conditions & MeSH terms

• Diastasis, Muscle
• Rectus Diastasis

Intervention

Procedure:
• ARD
surgical reconstruction with laparoscopic technique

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Ersta Hospital	Stockholm	Region Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence	computed tomography	1 year
Secondary	Visual Analog Pain Scale (VAS)	Scale from 0 to 10, where 0 is no pain and 10 is the worst possible pain	1 year, 3 years
Secondary	Abdominal stability	patient self-esteem by one question; do you feel that the instability of the abdominal wall has disappeared, yes/no/partially	1 year, 3 years
Secondary	SF-36 Quality of Life instrument	The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. Higher scores mean a better outcome.	1 year, 3 years
Secondary	VHPQ is a questionnaire for the assessment of pre- and postoperative pain	The questionnaire comprises 20 questions The first six questions concern the level and duration of pain. The next seven questionsrelate to the impact on daily activities. The final questions deal with patient satisfaction and how physically demanding the patients regard their occupation. Pain intensity in the VHPQ is assessed using a 7-step fixed-point rating scale with steps linked to pain behavior rather than numbers or verbal descriptors of pain. Higher scores mean a worse outcome.	1 year, 3 years