Rein4CeTo1: Hernia After Colorectal Cancer Surgery: an RCT Comparing 4:1-technique With or Without a Reinforced Tension Line Suture
Study Details
Study Description
Brief 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. 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 10% (15% 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 costs for incisional hernia treatment during 3 years as well as patient satisfaction and quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 10% (15% without and 5% with reinforced tension-line suture) is assumed and requires inclusion of 169 patients in each group (significance level=5%, power=80% and compensation for a 20% drop-out). 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 costs for incisional hernia treatment during 3 years as well as 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 this autumn and are estimated to be completed after somewhat more than 2 years. The last follow-up will thereby take place after an additional 3 years (2022).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 4:1 closure group Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall. |
Procedure: 4:1 closure group
In this arm the incisions are closed by the 4:1-technique
|
| Active Comparator: RTL plus 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 a reinforced tension-line suture in addition to the 4:1-technique
|
Outcome Measures
Primary Outcome Measures
- Incisional hernia one year after colorectal cancer surgery comparing a standardized 4:1-technique with and without a reinforced tension-line suture [One year]
Evaluated by clinical investigation and CT-scan
Secondary Outcome Measures
- Wound dehiscence and other wound complications [One month or longer]
Early outcome measures investigated during hospitalization and at 1 month follow-up and until wound complication is healed
- Incisional hernia after 3 years [3 years]
Evaluated by clinical investigation and CT-scan
- Costs for treatment of incisional hernias during 3 years [3 years]
According to protocols and review of patients records
- Abdominal wall discomfort at 1- and 3 years follow-up [1 and 3 years]
Measured by a modified version of the Ventral Hernia Pain Questionnaire
- Quality of life after 1- and 3 years [1 and 3 years]
Measured by the EQ-5D-5L questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria: Patient aged > 18 years planned for colorectal cancer surgery through a midline incision -
Exclusion Criteria: 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 and patient not willing to take part in the study.
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of surgery, Skane university hospital | Malmö | Sweden | SE 205 02 |
Sponsors and Collaborators
- Skane University Hospital
- Kristianstad Hospital
- Ystad Hospital
Investigators
- Principal Investigator: Ulf Petersson, MD, Ass Prof, Department of Surgery, Skane University Hospital, Malmö Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
- Agarwal 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.
- 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. Review.
- Hollinsky 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.
- Millbourn 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.
- Muysoms FE, Dietz UA. Prophylactic meshes in the abdominal wall. Chirurg. 2017 Jan;88(Suppl 1):34-41. doi: 10.1007/s00104-016-0229-7. Review.
- SkaneU