Hernia After Colorectal Cancer Surgery (Rein4CeTo1)

• ClinicalTrials.gov Identifier: NCT03390764
• Recruitment Status: Active, not recruiting
• First Posted: January 4, 2018
• Last Update Posted: September 9, 2022
• Sponsor: Skane University Hospital
• Information provided by (Responsible Party): Ulf Petersson, Skane University Hospital

Tracking Information

• First Submitted Date: December 28, 2017
• First Posted Date: January 4, 2018
• Last Update Posted Date: September 9, 2022
• Actual Study Start Date: October 16, 2017
• Actual Primary Completion Date: May 20, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2018)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 6, 2022)

• Wound dehiscence and other wound complications [ Time Frame: 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 [ Time Frame: 3 years ]
  Evaluated by clinical investigation and CT-scan
• Abdominal wall discomfort at 1- and 3 years follow-up [ Time Frame: 1 and 3 years ]
  Measured by a modified version of the Ventral Hernia Pain Questionnaire
• Quality of life after 1- and 3 years [ Time Frame: 1 and 3 years ]
  Measured by the EQ-5D-5L questionnaire

Original Secondary Outcome Measures (submitted: January 3, 2018)

• Wound dehiscence and other wound complications [ Time Frame: 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 [ Time Frame: 3 years ]
  Evaluated by clinical investigation and CT-scan
• Costs for treatment of incisional hernias during 3 years [ Time Frame: 3 years ]
  According to protocols and review of patients records
• Abdominal wall discomfort at 1- and 3 years follow-up [ Time Frame: 1 and 3 years ]
  Measured by a modified version of the Ventral Hernia Pain Questionnaire
• Quality of life after 1- and 3 years [ Time Frame: 1 and 3 years ]
  Measured by the EQ-5D-5L questionnaire

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hernia After Colorectal Cancer Surgery
• 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
• 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 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Multicenter randomized controlled trial

Masking: None (Open Label)
Primary Purpose: Prevention

Condition

• Incisional Hernia
• Wound Dehiscence
• Wound Complication
• Quality of Life

Intervention

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

Study Arms

• Active Comparator: 4:1 closure group
  Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall.
  Intervention: Procedure: 4:1 closure group
• 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.
  Intervention: Procedure: RTL plus 4:1 closure group

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.
• 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.
• 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. doi: 10.1016/j.amjsurg.2006.09.045.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 6, 2022): 152
• Original Estimated Enrollment (submitted: January 3, 2018): 338
• Estimated Study Completion Date: May 20, 2024
• Actual Primary Completion Date: May 20, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03390764
• Other Study ID Numbers: SkaneU
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ulf Petersson, Skane University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Skane University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ulf Petersson, MD, Ass Prof; Department of Surgery, Skane University Hospital, Malmö Sweden

• PRS Account: Skane University Hospital
• Verification Date: September 2022