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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT01586741
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 3
• Actual Duration (Months): 36
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Abdominal Hernias and Other Abdominal Wall Conditions; Post-operative Pain; Recurrence	Procedure: Quill suture application for repair or polypropylene mesh	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
• Actual Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Polypropylene mesh Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients.	Procedure: Quill suture application for repair or polypropylene mesh; 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
Active Comparator: quill suture 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; 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
No Intervention: conservative treatment Regular abdominal exercises workout for three months for 30 patients.

Outcome Measures

Primary Outcome Measures

1. Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation. [follow-up 1 year after surgery]

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Abdominal wall diastasis> 3 cm

2. Discomfort or tenderness in the abdominal wall

3. Desire for abdominal wall reconstruction

4. Women have undergone at least one birth

5. Smoking cessation 1 month pre-and 3 months post-operatively

Exclusion Criteria:

1. <18 years old

2. Ongoing pregnancy

3. Ongoing breastfeeding

4. Current immunosuppressive therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clintec, Karolinska Institutet	Stockholm		Sweden	17176

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Study Director: Ulf S Gunnarsson, professor, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Emanuelsson, MD, consultant in plastic surgery, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT01586741
• Other Study ID Numbers: 2009/227-31/3/PE/96
• First Posted: Apr 27, 2012
• Last Update Posted: Dec 23, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Recurrence; Pain, Postoperative; Hernia, Abdominal; Internal Hernia

Study Results

Participant Flow

Arm/Group Title	Quill Suture	Polypropylene Mesh	Conservative Treatment
Arm/Group Description	Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training	Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training	Regular abdominal exercises workout for three months for 30 patients.
Period Title: Overall Study
STARTED	28	29	32
COMPLETED	27	29	30
NOT COMPLETED	1	0	2

Baseline Characteristics

Arm/Group Title	Polypropylene Mesh	Quill Suture	Conservative Treatment	Total
Arm/Group Description	Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training	Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training	Regular abdominal exercises workout for three months for 30 patients.	Total of all reporting groups
Overall Participants	29	28	32	89
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	29 100%	28 100%	31 96.9%	88 98.9%
>=65 years	0 0%	0 0%	1 3.1%	1 1.1%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	42	39.6	44.2	41.9
Sex: Female, Male (Count of Participants)
Female	28 96.6%	27 96.4%	32 100%	87 97.8%
Male	1 3.4%	1 3.6%	0 0%	2 2.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Sweden	29 100%	28 100%	32 100%	89 100%

Outcome Measures

1. Primary Outcome

Title	Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.
Description	All patients go through a CT scan and clinical examination one year after surgery
Time Frame	follow-up 1 year after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Polypropylene Mesh	Quill Suture	Conservative Treatment
Arm/Group Description	Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training	Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training	Regular abdominal exercises workout for three months for 30 patients.
Measure Participants	29	27	30
Count of Participants [Participants]	2 6.9%	3 10.7%	26 81.3%

2. Secondary Outcome

Title	Adverse Event Indicated in Case Report Formulary During the First 12 Months
Description	adverse event categorize as superficial wound infection, seroma, fistula or deep wound infection
Time Frame	follow-up 1 year after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Pain Post Operatively Measured by the VHPQ Questionnaires
Description	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
Time Frame	follow-up 1 year after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Quill Suture		Polypropylene Mesh		Conservative Treatment
Arm/Group Description	Reconstruction of the abdominal wall diastasis with double row absorbable suture ( Quill Self-retaining system) on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training		Reconstruction of the abdominal wall diastasis with insertion of a polypropylene mesh on 30 patients. Quill suture application for repair or polypropylene mesh: The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training		Regular abdominal exercises workout for three months for 30 patients.
All Cause Mortality
	Quill Suture		Polypropylene Mesh		Conservative Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/29 (0%)		0/30 (0%)
Serious Adverse Events
	Quill Suture		Polypropylene Mesh		Conservative Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/29 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Quill Suture		Polypropylene Mesh		Conservative Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/29 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.