Hernia After Colorectal Cancer Surgery (Rein4CeTo1)
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ClinicalTrials.gov Identifier: NCT03390764 |
Recruitment Status :
Active, not recruiting
First Posted : January 4, 2018
Last Update Posted : September 9, 2022
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Condition or disease | Intervention/treatment | Phase |
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Incisional Hernia Wound Dehiscence Wound Complication Quality of Life | Procedure: 4:1 closure group Procedure: RTL plus 4:1 closure group | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 152 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 |
Actual Primary Completion Date : | May 20, 2022 |
Estimated Study Completion Date : | May 20, 2024 |
Arm | Intervention/treatment |
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Active Comparator: 4:1 closure group
Patients randomized to and receiving the intervention small stitch 4:1 technique for closure of the abdominal wall.
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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.
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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 |
- 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
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390764
Sweden | |
Department of surgery, Skane university hospital | |
Malmö, Sweden, SE 205 02 |
Principal Investigator: | Ulf Petersson, MD, Ass Prof | Department of Surgery, Skane University Hospital, Malmö Sweden |
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 Key Record Dates |
Last Update Posted: | September 9, 2022 |
Last Verified: | September 2022 |
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 |
Incisional hernia 4:1-technique RTL-suture |
Hernia Incisional Hernia Wounds and Injuries |
Pathological Conditions, Anatomical Postoperative Complications Pathologic Processes |