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A Multi-center, single-blind, Randomized Controlled Trial Comparing Interrupted vs Continuous Fascial Closure in the Mini-laparotomy Incision During Laparoscopic or Robot-assisted Colorectal Resection (CLOSURE-CR trial)

A Multi-center, single-blind, Randomized Controlled Trial Comparing Interrupted vs Continuous Fascial Closure in the Mini-laparotomy Incision During Laparoscopic or Robot-assisted Colorectal Resection (CLOSURE-CR trial)

Yamaguchi Tomohiro

Cancer Institute Hospital, Japanese Foundation for Cancer Research

3-8-31,Ariake,Koto-ku,Tokyo,Japan

tyamaguchi-ncd@umin.ac.jp

Sato Kentaro

Cancer Institute Hospital, Japanese Foundation for Cancer Research

3-8-31,Ariake,Koto-ku,Tokyo,Japan

+81-3-3520-0111

Kentaro.sato@jfcr.or.jp

Recruiting

July. 13, 2026

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

treatment purpose

Patients who meet all of the following inclusion criteria and none of the exclusion criteria will be considered eligible for enrollment.
Inclusion Criteria
1.Patients with neoplastic lesions of the colon (including colorectal cancer, appendiceal tumors, neuroendocrine tumors, gastrointestinal stromal tumors, etc.) who are scheduled to undergo curative resection, and for whom laparoscopic or robot-assisted colorectal resection is planned.
2.Patients for whom a small midline laparotomy incision including the umbilicus is planned for bowel transection, anastomosis, and specimen retrieval.
3.Patients with an ECOG Performance Status (PS) of 0, 1, or 2.
4.Patients aged 18 years or older at the time of registration.
5.Patients who are scheduled to undergo an abdominal CT scan at approximately 1 year postoperatively, or for whom such imaging is considered feasible.
6.Patients with preserved function of major organs (including bone marrow, liver, kidney, and lungs) meeting the following criteria:
A) White blood cell count: >=2,000mm3 and <=15,000mm3
B) Hemoglobin: >=7.5 g/dL
C) Platelet count: >=75,000/mm3
D) Total bilirubin: <=2.0 mg/dL
E) Creatinine: <=2.0 mg/dL
7.Patients who have sufficient capacity to understand the study and have provided written informed consent.

1.Patients with umbilical hernia or incisional abdominal wall hernia at the planned umbilical incision site, as identified on preoperative imaging.
2.Patients scheduled to undergo emergency surgery.
3.Patients with active infections requiring systemic treatment.
4.Patients with a body temperature of >=38.0 degrees Celsius at the time of registration.
5.Patients with psychiatric disorders or symptoms that interfere with daily life and are judged to make participation in the study difficult.
6.Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
7.Patients who are scheduled to undergo abdominal surgery within 6 months after registration (e.g., planned surgery for metastatic liver tumors as a staged resection).

Both

Colorectal neoplastic lesions including colorectal cancer, appendiceal tumors, neuroendocrine tumor

Participants will be randomly assigned in a 1:1 ratio prior to surgery to one of the following two groups according to the method of fascial closure, and fascial closure will be performed using the allocated technique.
The fascial closure methods for each group are as follows:
Standard Treatment Group (Interrupted Suture Group)
-Suture material: PDS Plus No. 1 (Johnson & Johnson K.K.)
-Suturing technique: Interrupted sutures of the fascial layer of the anterior rectus sheath
-Pitch (suture interval): 10 mm
-Bite (distance from the wound edge): 10 mm
Investigational Treatment Group (Continuous Suture Group)
-Suture material: STRATAFIX Symmetric PDS Plus No. 1 (Johnson & Johnson K.K.)
-Suturing technique: Continuous suturing of the fascial layer of the anterior rectus sheath
-Pitch (suture interval): 5 mm
-Bite (distance from the wound edge): 5-8 mm

Incidence of incisional abdominal wall hernia at 12 months postoperatively

1.Time required for fascial closure
2.Wound pain score
3.Incidence of surgical site infection (SSI)
4.Incidence of wound dehiscence within 30 days postoperatively (due to fascial closure failure)
5.Incidence of overall postoperative complications within 30 days
6.Proportion of patients requiring reoperation for wound-related complications
7.Assessment of wound cosmesis (quality of life evaluation)
8.Incidence of abdominal reoperation up to 12 months postoperatively (hernia-related / non-hernia-related)
9.Incidence of abdominal reoperation up to 24 months postoperatively (hernia-related / non-hernia-related)
10.Hernia size in patients who develop incisional hernia
11.Incidence of incisional hernia at 24 months postoperatively
12.Incidence of incisional hernia at the stoma closure site at 12 months after stoma closure (the closure method-continuous or interrupted sutures-will follow the allocation at the time of the primary surgery; limited to stoma closures performed within 1 year after colorectal resection)

+81-3-3520-0111

June. 12, 2026

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