Clinical trial · Interventional

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

Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer: The SMART Trial (Single-Modified Anastomosis for Rectal Cancer Surgery Technique), A Multicenter Randomized Controlled Study

NCT07376980CI-TRIAL-00101968MSTenrolling by invitationN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Rectal Cancer	Malignant Rectal Neoplasm	CURATED_EXACT	0.92
Rectal Cancer Surgery	—	UNRESOLVED	—
Rectal Neoplasms	Rectal Neoplasm	ONTOLOGY_EXACT	0.98
Rectal Neoplasms Malignant	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Modified single-stapled anastomosis technique	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Modified single-stapled anastomosis technique
description
Participants assigned to this arm will undergo minimally invasive low anterior resection using the modified single-stapled technique. After rectal resection, the two ends of the linear staple line of stump are approximated toward the center using a barbed suture. The circular stapler spike is introduced through the center of the staple line to ensure complete resection of the linear staple line, eliminating staple-line intersections. The reaminder of the procedure, including total mesorectal excision, follows standard oncologic principles.
interventionNames
1. Procedure: Modified single-stapled anastomosis technique
type
NO_INTERVENTION
label
Double-stapled anastomosis technique
description
Participants assigned to this arm will undergo minimally invasive low anterior resection using the conventional double-stapled technique. The rectum is transected with linear stapler, followed by transanal introduction of a circular stapler to create an end-to-end anastomosis. The procedure represents current standard practice for low anterior resection in rectal cancer.

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 19 Years

Show eligibility criteria text

Inclusion Criteria:

* Adult patients with rectal cancer who are scheduled to undergo laparoscopic or robotic low anterior resection
* histologically confirmed rectal adenocarcinoma located within 15cm from anal verge.
* ECOG performance status of 0 to 2
* Any clinical stage

Exclusion Criteria:

* Who have significant comorbidities or history of abdominal surgeries that would preclude a minimally invasive approach
* Bowel obstruction for perforation requiring emergency surgey
* Concurrent, or recent treatment for colorectal or other malignancies within the past five years
* Presence of inflammatory bowel diseases
* Hereditary colorectal cancer syndrome

References

Publications (1)

pubmedPublishedShowing 1–1 of 1 indexed publications citing this registration · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Modified single-stapled anastomosis in laparoscopic or robotic low anterior resection for rectal cancer: protocol for a multicentre randomised controlled trial.
Hyo Seon Ryu, Jung-Myun Kwak, Se-Jin Baek et al. · BMJ Open · Sep 21, 2026 · PMID 42767745 pubmed

Registry

Dates and enrollment

Start: Dec 20, 2025
Primary completion: Dec 30, 2027
Completion: Dec 30, 2030
First posted: Jan 29, 2026
Last update posted: Jan 29, 2026
Enrollment: 450 (estimated)
Lead sponsor: Korea University Anam Hospital OTHER
Collaborators: Kyunghee University Medical Center; Seoul National University Hospital; Kyungpook National University Chilgok Hospital; Saint Vincent's Hospital, Korea; Sinchon Severance Hospital, Yonsei University College of Medicine
Keywords: Rectal Cancer, Total Mesorectal Excision, Low Anterior Resection, Anastomotic Leak, Anastomosis, Surgical, Stapled anastomosis, Modified Single-Stapled Technique, Minimally Invasive Rectal Surgery

Data updated 22 days agoSource updated Jan 29, 2026source: clinicaltrials

Locations

Locations by country (6)

Country	Sites	Recruiting
South Korea	6	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.