Extra-Peritoneal Tunneling Versus Conventional Drain Fixation After Anterior or Low Anterior Resection

Summary

The goal of this clinical trial is to learn whether the extra-peritoneal tunneling (EPT) drain fixation method works better and more safely than the conventional drain insertion method after rectal cancer surgery.

It will also learn about the safety and possible complications of the EPT technique.

The main questions it aims to answer are:

Does the EPT drain fixation method increase the success rate of conservative management (drain maintenance and/or antibiotics) when an anastomotic leak occurs?

Does the EPT method reduce the rate of drain displacement compared with the conventional method?

Are there any safety concerns or complications associated with the EPT method?

Researchers will compare EPT drain fixation to the conventional drain method to see which approach provides better outcomes after anterior or low anterior resection for rectal cancer.

Participants will:

Undergo anterior or low anterior resection for rectal cancer as part of their standard surgical treatment.

Be randomly assigned to either the EPT drain fixation group or the conventional drain group.

Receive the same postoperative care as usual, including follow-up imaging to monitor drain position and recovery.

Be observed for postoperative outcomes such as anastomotic leakage, drain position, and related complications until recovery.

This study will help determine whether securing the drain through an extra-peritoneal tunnel can prevent drain movement, improve early management of leakage, and enhance patient recovery after rectal surgery.

Conditions

• Rectal Diseases, Sigmoid Colon Disease
• Rectal Cancer, Sigmoid Colon Cancer

Interventions

PROCEDURE

EPT drain fixation

Participants in this arm will receive pelvic drain placement using the extra-peritoneal tunneling (EPT) drain fixation method after anterior or low anterior resection for rectal cancer. The drain is then passed through this tunnel and positioned close to the anastomosis to maintain stable drainage and prevent displacement

PROCEDURE

Conventional drain insertion

Participants in this arm will receive pelvic drain placement using the conventional transperitoneal method after anterior or low anterior resection for rectal cancer. In this standard technique, the drain is inserted directly through a lower abdominal port site (usually the left lower quadrant) into the pelvic cavity without creating an extraperitoneal tunnel

Sponsors & Collaborators

• Konyang University Hospital

  collaborator OTHER

• Daegu Catholic University Medical Center

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Chungbuk National University Hospital

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Pusan National University Yangsan Hospital

  collaborator OTHER

• Chonbuk National University Hospital

  collaborator OTHER

• Kyungpook National University Chilgok Hospital

  collaborator OTHER

• Yonsei University Yongin Severance Hospital

  collaborator UNKNOWN

• Chonnam National University Hospital

  collaborator OTHER

• Ewha Womans University Seoul Hospital

  collaborator OTHER

• Soonchunhyang University Hospital

  collaborator OTHER

• Hallym University Dongtan Sacred Heart Hospital

  collaborator OTHER

• Yeungnam University Hospital

  lead OTHER

Principal Investigators

• SUNG IL KANG, M.D., Ph.D. · Yeungnam University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2028-12-31

Completion

2029-02-28

Countries

• South Korea

Study Locations