Incisional HerniaRein4CeTo1NCT03390764
Hernia After Colorectal Cancer Surgery
A study testing 4:1 closure group and RTL plus 4:1 closure group in people with Incisional Hernia and Wound Dehiscence, run by Skane University Hospital at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Wound Dehiscence, Wound Complication
- What is being tested?
- 4:1 closure group and RTL plus 4:1 closure group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2017to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years planned for colorectal cancer surgery through a midline incision
Who cannot join
- Former incisional hernia surgery in the midline
- Present incisional hernia in the midline
- ASA>3
- Peritoneal carcinomatosis eligible for peritonealectomy/HIPEC
- Patient not able to participate in follow-up
- Patient not willing to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rein4CeTo1: Incisional Hernia After Colorectal Cancer Surgery - a Randomized Controlled Multicentre Trial Comparing Small Stitch 4:1-technique With Respectively Without a Reinforced Tension-line Suture for Abdominal Closure
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.
Read the detailed description
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).
- Being tested
- 4:1 closure group, RTL plus 4:1 closure group
- Keywords
- Incisional hernia, 4:1-technique, RTL-suture
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4:1 closure groupProcedure or surgery
In this arm the incisions are closed by the 4:1-technique
RTL plus 4:1 closure groupProcedure or surgery
In this arm the incisions are closed by a reinforced tension-line suture in addition to the 4:1-technique
| Study group | Role | What they receive |
|---|---|---|
| 4:1 closure group | Active comparator | Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall. Receives: Procedure: 4:1 closure group |
| RTL plus 4:1 closure group | Active comparator | Patients randomized to and receiving the intervention reinforced tension-line suture plus small stitch 4:1 technique for closure of the abdominal wall. Receives: Procedure: RTL plus 4:1 closure group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (4)
Wound dehiscence and other wound complications
Early outcome measures investigated during hospitalization and at 1 month follow-up and until wound complication is healed
Measured: One month or longer
Incisional hernia after 3 years
Evaluated by clinical investigation and CT-scan
Measured: 3 years
Abdominal wall discomfort at 1- and 3 years follow-up
Measured by a modified version of the Ventral Hernia Pain Questionnaire
Measured: 1 and 3 years
Quality of life after 1- and 3 years
Measured by the EQ-5D-5L questionnaire
Measured: 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start16 Oct 2017
- Primary completion20 May 2022
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulf Petersson, Skane University Hospital
- Investigators
- Ulf Petersson, MD, Ass Prof, Principal investigator, Department of Surgery, Skane University Hospital, Malmö Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390764
- Sponsor's protocol ID
- SkaneU
- Acronym
- Rein4CeTo1
- Status last verified
- Sep 2022
- First submitted
- 28 Dec 2017
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bosanquet DC, Ansell J, Abdelrahman T, Cornish J, Harries R, Stimpson A, Davies L, Glasbey JC, Frewer KA, Frewer NC, Russell D, Russell I, Torkington J. Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS One. 2015 Sep 21;10(9):e0138745. doi: 10.1371/journal.pone.0138745. eCollection 2015.
PubMed 26389785Muysoms FE, Dietz UA. Prophylactic meshes in the abdominal wall. Chirurg. 2017 Jan;88(Suppl 1):34-41. doi: 10.1007/s00104-016-0229-7.
PubMed 27460229Hollinsky C, Sandberg S, Kocijan R. Preliminary results with the reinforced tension line: a new technique for patients with ventral abdominal wall hernias. Am J Surg. 2007 Aug;194(2):234-9. doi: 10.1016/j.amjsurg.2006.09.045.
PubMed 17618812Agarwal A, Hossain Z, Agarwal A, Das A, Chakraborty S, Mitra N, Gupta M, Ray U. Reinforced tension line suture closure after midline laparotomy in emergency surgery. Trop Doct. 2011 Oct;41(4):193-6. doi: 10.1258/td.2011.110045. Epub 2011 Aug 10.
PubMed 21831931Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189.
PubMed 19917943Wenzelberg CL, Rogmark P, Ekberg O, Petersson U. Reinforced tension-line suture after laparotomy: early results of the Rein4CeTo1 randomized clinical trial. Br J Surg. 2024 Sep 3;111(10):znae265. doi: 10.1093/bjs/znae265.
PubMed 39475416
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rein4CeTo1: Incisional Hernia After Colorectal Cancer Surgery - a Randomized Controlled Multicentre Trial Comparing Small Stitch 4:1-technique With Respectively Without a Reinforced Tension-line Suture for Abdominal Closure
- ClinicalTrials.gov ID
- NCT03390764
- Acronym / sponsor ID
- Rein4CeTo1 / SkaneU
- Keywords
- Incisional hernia, 4:1-technique, RTL-suture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 4:1 closure group | Active comparator | Procedure: 4:1 closure groupPatients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall. |
| RTL plus 4:1 closure group | Active comparator | Procedure: RTL plus 4:1 closure groupPatients randomized to and receiving the intervention reinforced tension-line suture plus small stitch 4:1 technique for closure of the abdominal wall. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 18 years planned for colorectal cancer surgery through a midline incision
Key exclusion criteria (6 listed)
- Former incisional hernia surgery in the midline
- Present incisional hernia in the midline
- ASA>3
- Peritoneal carcinomatosis eligible for peritonealectomy/HIPEC
- Patient not able to participate in follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4:1 closure groupIn this arm the incisions are closed by the 4:1-technique | Procedure or surgery | 4:1 closure group |
| RTL plus 4:1 closure groupIn this arm the incisions are closed by a reinforced tension-line suture in addition to the 4:1-technique | Procedure or surgery | RTL plus 4:1 closure group |
Primary outcome
Incisional hernia one year after colorectal cancer surgery comparing a standardized 4:1-technique with and without a reinforced tension-line suture
Time frame: One year
Evaluated by clinical investigation and CT-scan
4 secondary outcomes
Wound dehiscence and other wound complications
Time frame: One month or longer
Incisional hernia after 3 years
Time frame: 3 years
Abdominal wall discomfort at 1- and 3 years follow-up
Time frame: 1 and 3 years
Quality of life after 1- and 3 years
Time frame: 1 and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Background: PubMed 26389785Bosanquet DC, Ansell J, Abdelrahman T, Cornish J, Harries R, Stimpson A, Davies L, Glasbey JC, Frewer KA, Frewer NC, Russell D, Russell I, Torkington J. Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS One. 2015 Sep 21;10(9):e0138745. doi: 10.1371/journal.pone.0138745. eCollection 2015.
- Background: PubMed 27460229Muysoms FE, Dietz UA. Prophylactic meshes in the abdominal wall. Chirurg. 2017 Jan;88(Suppl 1):34-41. doi: 10.1007/s00104-016-0229-7.
- Background: PubMed 17618812Hollinsky C, Sandberg S, Kocijan R. Preliminary results with the reinforced tension line: a new technique for patients with ventral abdominal wall hernias. Am J Surg. 2007 Aug;194(2):234-9. doi: 10.1016/j.amjsurg.2006.09.045.
- Background: PubMed 21831931Agarwal A, Hossain Z, Agarwal A, Das A, Chakraborty S, Mitra N, Gupta M, Ray U. Reinforced tension line suture closure after midline laparotomy in emergency surgery. Trop Doct. 2011 Oct;41(4):193-6. doi: 10.1258/td.2011.110045. Epub 2011 Aug 10.
- Background: PubMed 19917943Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189.
- Derived from this study: PubMed 39475416Wenzelberg CL, Rogmark P, Ekberg O, Petersson U. Reinforced tension-line suture after laparotomy: early results of the Rein4CeTo1 randomized clinical trial. Br J Surg. 2024 Sep 3;111(10):znae265. doi: 10.1093/bjs/znae265.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Petersson, MD, Ass Prof principal investigator
Department of Surgery, Skane University Hospital, Malmö Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4:1 closure group and RTL plus 4:1 closure group in people with Incisional Hernia and Wound Dehiscence, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia one year after colorectal cancer surgery comparing a standardized 4:1-technique with and without a reinforced tension-line suture (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03390764, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.