Hernia After Colorectal Cancer Surgery: an RCT Comparing 4:1-technique With or Without a Reinforced Tension Line Suture (Rein4CeTo1)

• ClinicalTrials.gov Identifier: NCT03390764
• Recruitment Status: Recruiting
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Sponsor: Skane University Hospital
• Collaborators: Kristianstad Hospital; Ystad Hospital
• Information provided by (Responsible Party): Ulf Petersson, Skane University Hospital

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
Incisional Hernia; Wound Dehiscence; Wound Complication; Quality of Life	Procedure: 4:1 closure group; Procedure: RTL plus 4:1 closure group	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 338 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Multicenter randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 16, 2017
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2022

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 :

1. 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

Secondary Outcome Measures :

1. 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
2. Incisional hernia after 3 years [ Time Frame: 3 years ]
   Evaluated by clinical investigation and CT-scan
3. Costs for treatment of incisional hernias during 3 years [ Time Frame: 3 years ]
   According to protocols and review of patients records
4. 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
5. Quality of life after 1- and 3 years [ Time Frame: 1 and 3 years ]
   Measured by the EQ-5D-5L questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts

Contact: Ulf Petersson, MD, Ass Prof; +46 40 337522; ulf.a.petersson@telia.com

Contact: Charlotta Wenzelberg, MD; + 46 40 333791; charlotta.wenzelberg@skane.se

Locations

Sweden

Department of surgery, Skane university hospital; Recruiting

Malmö, Sweden, SE 205 02

Contact: Ulf Petersson, MD, Ass Prof +46 40 337522 ulf.a.petersson@telia.com

Contact: Charlotta Wenzelberg, MD +46 40 333791 charlotta.wenzelberg@skane.se

Principal Investigator: Thordur Bjarnason, MD, PhD

Principal Investigator: Anna Allfelt, MD

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

More Information

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. Review.

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.

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.

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.

• Responsible Party: Ulf Petersson, MD, PhD, Ass Prof, Skane University Hospital
• ClinicalTrials.gov Identifier: NCT03390764
• Other Study ID Numbers: SkaneU
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Keywords provided by Ulf Petersson, Skane University Hospital:

Incisional hernia; 4:1-technique; RTL-suture

Additional relevant MeSH terms:

Hernia; Incisional Hernia; Wounds and Injuries; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes