The SMART Trial: Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer

Summary

The goal of this clinical trial is to learn whether a modified single-stapled anastomosis (MST) can reduce anastomotic leakage compared with the conventional double-stapled technique (DST) in adult patients undergoing laparoscopic or robotic low anterior resection for rectal cancer.

The main questions it aims to answer are:

* Does MST lower the incidence of anastomotic leakage after rectal cancer surgery?
* Does MST improve short-term surgical outcomes compared with DST?

Researchers will compare the MST group with the DST group to see if MST leads to fewer anastomotic leaks and safer postoperative recovery.

Participants will:

Receive either MST or DST during minimally invasive rectal cancer surgery Undergo routine postoperative CT scans within one month after surgery to check for symptomatic or asymptomatic anastomotic leakage Attend scheduled follow-up visits and standard postoperative assessments as part of routine rectal cancer care

Conditions

• Rectal Neoplasms
• Rectal Neoplasms Malignant
• Rectal Cancer
• Rectal Cancer Surgery

Interventions

PROCEDURE

Modified single-stapled anastomosis technique

This intervention applies a modified single-stapled anastomosis specifically to low anterior resection (LAR), where the technique has not been previously evaluated in a randomized controlled trial. Although similar concepts have been explored in anterior resection, their application in LAR is technically more challenging due to the deeper pelvic working space and more limited access to the rectal stump. In earlier studies, approximation of the linear staple line was performed through a Pfannelstein incision or mini-laparotomy incision during specimen extraction. In contrast, this trial utilizes a fully intracorporeal approach.

Sponsors & Collaborators

• Kyunghee University Medical Center

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Kyungpook National University Chilgok Hospital

  collaborator OTHER

• Saint Vincent's Hospital, Korea

  collaborator OTHER

• Sinchon Severance Hospital, Yonsei University College of Medicine

  collaborator UNKNOWN

• Korea University Anam Hospital

  lead OTHER

Principal Investigators

• Jin Kim, M.D., Ph.D · Korea University Anam Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-20

Primary Completion

2027-12-30

Completion

2030-12-30

Countries

• South Korea

Study Locations