Trial Outcomes & Findings for A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis (NCT NCT01586741)

NCT ID: NCT01586741

Last Updated: 2020-12-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: follow-up 1 year after surgery
• Results posted on: 2020-12-23

Participant Flow

Participant milestones

Measure	Quill Suture 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	Polypropylene Mesh 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	Conservative Treatment Regular abdominal exercises workout for three months for 30 patients.
Overall Study STARTED	28	29	32
Overall Study COMPLETED	27	29	30
Overall Study NOT COMPLETED	1	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Polypropylene Mesh n=29 Participants 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	Quill Suture n=28 Participants 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	Conservative Treatment n=32 Participants Regular abdominal exercises workout for three months for 30 patients.	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=29 Participants	0 Participants n=28 Participants	0 Participants n=32 Participants	0 Participants n=89 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=29 Participants	28 Participants n=28 Participants	31 Participants n=32 Participants	88 Participants n=89 Participants
Age, Categorical >=65 years	0 Participants n=29 Participants	0 Participants n=28 Participants	1 Participants n=32 Participants	1 Participants n=89 Participants
Age, Continuous	42 years n=29 Participants	39.6 years n=28 Participants	44.2 years n=32 Participants	41.9 years n=89 Participants
Sex: Female, Male Female	28 Participants n=29 Participants	27 Participants n=28 Participants	32 Participants n=32 Participants	87 Participants n=89 Participants
Sex: Female, Male Male	1 Participants n=29 Participants	1 Participants n=28 Participants	0 Participants n=32 Participants	2 Participants n=89 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	29 participants n=29 Participants	28 participants n=28 Participants	32 participants n=32 Participants	89 participants n=89 Participants

PRIMARY outcome

Timeframe: follow-up 1 year after surgery

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

Outcome measures

Measure	Polypropylene Mesh n=29 Participants 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	Quill Suture n=27 Participants 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	Conservative Treatment n=30 Participants Regular abdominal exercises workout for three months for 30 patients.
Recurrence of Diastasis One Year Post-operatively That Indicated by CT Scan or Clinical Investigation.	2 Participants	3 Participants	26 Participants

SECONDARY outcome

Timeframe: follow-up 1 year after surgery

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Quill Suture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Polypropylene Mesh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conservative Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

D. Peter Emanuelsson

Karolinska University Hospital

Phone: +46851770000

Email: peter.emanuelsson@sll.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place