NIPH Clinical Trials Search

A study comparing different wound closure methods to prevent infection after colorectal cancer surgery

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Colorectal cancer
Date of first enrollment	15/04/2026
Target sample size	2000
Countries of recruitment
Study type	Interventional
Intervention(s)	This study evaluates wound closure techniques using a 2x2 factorial design, comparing subcutaneous suturing (with vs without) and fascial closure methods (continuous vs interrupted) in laparoscopic or robot-assisted colorectal cancer surgery.

Outcome(s)

Primary Outcome	Incidence of superficial incisional surgical site infection (SSI) within 30 days postoperatively, defined according to CDC criteria, with an ASEPSIS score >20 considered as confirmed SSI.
Secondary Outcome	Incidence of incisional hernia at 12 and 24 months postoperatively, assessed by abdominal CT and clinical examination.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Patients aged >=18 years with colorectal cancer who are scheduled to undergo laparoscopic or robot-assisted resection (with a mini-laparotomy via a midline or Pfannenstiel incision). - Patients in whom wound closure can be performed according to the study protocol. - Patients who have received a full explanation of the study and have provided written informed consent.
Exclude criteria	- Patients diagnosed with colorectal cancer accompanied by bowel obstruction who are judged to require emergency or urgent surgery, those requiring preoperative colonic stent placement, or those considered unsuitable for standard mechanical bowel preparation. - Patients scheduled for placement of prosthetic material (e.g., immediate mesh implantation) at the same incision site. - Patients with severe active infection or immunocompromised conditions (e.g., severe neutropenia). - Pregnant women or those with a high possibility of pregnancy. - Patients in whom standardization of the study procedures is considered difficult (e.g., inability to adhere to the protocol in emergency surgery). - Patients judged to be inappropriate for inclusion in the study by the principal investigator.