An interventional study of 4:1 closure group and RTL plus 4:1 closure group in Incisional Hernia, Wound Dehiscence and Wound Complication, sponsored by Skane University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by Skane University Hospital · Not applicable, Interventional, and Prevention
Among 10 studies in Incisional Hernia with a site in Sweden — 5 open to participants now, 5 under way, none of them phase 3. Incisional Hernia · Sweden.
Among the 10 studies in Incisional Hernia with a site in Sweden, this one is the only one that started in 2017, is one of 9 with no phase, and was the 4th registered.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
Browse Incisional Hernia studies →5 of the 10 studies in Incisional Hernia with a site in Sweden are open now. Recruiting first, the newest first:
Suturion AB · Sites in Sweden
Ages 18+
Uppsala University · Sites in Sweden
Ages 18+
Umeå University · Sites in Sweden
Ages 18+
Karolinska Institutet · Sites in Sweden
Ages 18–100
Ersta Diakoni · Sites in Sweden
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 38 Incisional Hernia studies recruiting now, 27 (71%) set no upper age limit and 2 (5%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
This study's enrollment of 152 is above the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Median enrollment 200 across the 9 interventional studies, 157 across the 1 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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2 of 10 have an industry lead sponsor. The 7 most frequent:
Skane University Hospital is the lead sponsor of 73 studies on the registry; 17 are open to participants now.
Skane University Hospital has 4 studies filed under Incisional Hernia — fewer than ten, so there is no comparison to draw.
1 of the studies in Incisional Hernia with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07316426Umeå UniversityPreoptimisation in Ventral Hernia Surgery | 2027-09-01 |
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Among the 10 studies in Incisional Hernia with a site in Sweden, from their registry updates:
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Defects in the abdominal wall (incisional hernia) is a frequent negative outcome after surgery. Reinforcing the incision with mesh seem to lower the incidence but in surgery that includes bowel resection a simple alternative, cheaper and less prone to infection than a synthetic mesh, would be of interest. The primary aim of this multicentre randomized controlled trial is to compare the incisional hernia incidence one year after planned colorectal cancer surgery performed through a midline incision which is closed either by a standardized small stitch 4:1 technique (the incision is closed with the use of suture of 4 times the length of the incision) or with the same technique plus a reinforced tension-line suture (a suture is applied in the fibrous tissue parallel to the incision which is then embraced by the 4:1 suture when the incision is closed). A difference in incisional hernia of 15% (20% without and 5% with reinforced tension-line suture) is assumed. Secondary aims are to evaluate incidences of wound dehiscence, other wound complications and incisional hernia after 3 years. Furthermore we aim to evaluate patient satisfaction and quality of life.
The primary aim of this multicentre randomized controlled trial is to compare the incisional hernia incidence one year after planned colorectal cancer surgery performed through a midline incision which is closed either by a standardized small stitch 4:1 technique or with the same technique plus a reinforced tension-line suture. A difference in incisional hernia of 15% (20% without and 5% with reinforced tension-line suture) is assumed and requires inclusion of 76 patients in each group (significance level=5%, power=80%). Patients planned for colorectal surgery due to a cancer are eligible for inclusion. Exclusion criteria are: age below 18, ASA>3, former operation for incisional hernia in the midline, present hernia, perop findings of peritoneal carcinomatosis eligible for peritonealectomy, patient unable to take part in planned follow-up and patient not willing to take part in the study.
Secondary aims are to evaluate incidences of wound dehiscence, other wound complications and incisional hernia after 3 years. Furthermore we aim to evaluate patient satisfaction and quality of life.
Patient base-line characteristics, operative and postop characteristics will be recorded in inclusion- and op-protocols and protocols for clinical follow-up at 1 month, 1 and 3 years. Standard 1 and 3 years CT-scans will be examined for incisional hernia. At 1 and 3 years the patients will be asked to fill out an abdominal wall discomfort enquiry as well as the QoL questionnaire EQ-5D-5L.
The study will be performed at 3 surgical clinics in the Region of Skane in Sweden: Malmö, Kristianstad and Ystad. Inclusion started Oct 2017 and was estimated to be completed after somewhat more than 2 years. The pandemic added 2 years to the inclusion period.The last follow-up will thereby take place after an additional 3 years (2024).
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Exclusion Criteria:
Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall.
Procedure: 4:1 closure group
Patients randomized to and receiving the intervention reinforced tension-line suture plus small stitch 4:1 technique for closure of the abdominal wall.
Procedure: RTL plus 4:1 closure group
In this arm the incisions are closed by the 4:1-technique
In this arm the incisions are closed by a reinforced tension-line suture in addition to the 4:1-technique
Incisional hernia one year after colorectal cancer surgery comparing a standardized 4:1-technique with and without a reinforced tension-line suture
Evaluated by clinical investigation and CT-scan
Time frame: One year
Wound dehiscence and other wound complications
Early outcome measures investigated during hospitalization and at 1 month follow-up and until wound complication is healed
Time frame: One month or longer
Incisional hernia after 3 years
Evaluated by clinical investigation and CT-scan
Time frame: 3 years
Abdominal wall discomfort at 1- and 3 years follow-up
Measured by a modified version of the Ventral Hernia Pain Questionnaire
Time frame: 1 and 3 years
Quality of life after 1- and 3 years
Measured by the EQ-5D-5L questionnaire
Time frame: 1 and 3 years
Plan to share: Undecided
Ran from Oct 2017 to primary completion in May 2022, 55 months.
Of 59 non-industry interventional studies with no phase under Incisional Hernia, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 59. This study's 55 months is above that.
Counting every sponsor, half of 66 studies reached it within 43 months; a quarter within 29 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Skane University Hospital