Hernia After Colorectal Cancer Surgery

Quality of Life Clinical Trial

— Rein4CeTo1  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03390764
• Other study ID #: SkaneU
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: May 20, 2024

Study information

• Verified date: September 2022
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 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

• Patient not willing to take part in the study

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Quality of Life
• Wound Complication
• Wound Dehiscence
• Wounds and Injuries

Intervention

Procedure:
• 4:1 closure group
In this arm the incisions are closed by the 4:1-technique
• 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

Locations

Country	Name	City	State
Sweden	Department of surgery, Skane university hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year
Secondary	Wound dehiscence and other wound complications	Early outcome measures investigated during hospitalization and at 1 month follow-up and until wound complication is healed	One month or longer
Secondary	Incisional hernia after 3 years	Evaluated by clinical investigation and CT-scan	3 years
Secondary	Abdominal wall discomfort at 1- and 3 years follow-up	Measured by a modified version of the Ventral Hernia Pain Questionnaire	1 and 3 years
Secondary	Quality of life after 1- and 3 years	Measured by the EQ-5D-5L questionnaire	1 and 3 years