Reinforced tension-line suture after laparotomy: early results of the Rein4CeTo1 randomized clinical trial.

Background: The aim was to investigate whether adding a reinforced tension-line (RTL) suture to a standard 4 : 1 small-bite closure would reduce the incidence of incisional hernia after colorectal cancer surgery.

Methods: Patients aged at least 18 years, who were scheduled for elective colorectal cancer surgery through a midline incision at two Swedish hospitals (2017-2021), were randomized in a 1 : 1 ratio to either fascial closure with RTL and 4 : 1 small-bite closure with polypropylene sutures (RTL group) or 4 : 1 small-bite closure with polydioxanone suture alone (PDS group). The primary outcome was CT-detected incisional hernia 1 year after surgery. CT interpreters were blinded regarding treatment group.

Results: In all, 160 patients were randomized, 80 in each group. The study closed early to recruitment and follow-up. Some 134 patients were analysed at 1 year: 63 in the RTL group and 71 in the PDS group. Nineteen patients were found to have an incisional hernia: 4 (6%) in the RTL group and 15 (21%) in the PDS group (OR 3.95, 95% c.i. 1.24 to 12.60; P = 0.014). No unintended effects were found in either group.

Conclusion: Adding an RTL suture at fascial closure decreased the incidence of incisional hernia in patients undergoing surgery for colorectal cancer. Trial registration: NCT03390764 (https://clinicaltrials.gov).