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

NCT07241143 | Not Yet Recruiting

• 1 other identifier: 2025-08-031
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

drain, anterior resection, low anterior resection

Outcome Measures

Primary Outcomes (1)

• Rate of successful conservative management in patients who developed an anastomotic leak

  The success of conservative management is defined as resolution of the anastomotic leak without the need for reoperation or diversion. Success rates will be compared between patients managed with the Extra-Peritoneal Tunneling (EPT) drain fixation method and those with the conventional intraperitoneal drain placement.

  Within 60 days after diagnosis of anastomotic leak

Secondary Outcomes (5)

• Incidence of drain displacement according to drain fixation method

  Up to drain removal, an average of 7 days

• Time to drain displacement (days)

  Up to drain removal, an average of 7 days

• Incidence and types of drain-related complications according to drain fixation method

  Up to drain removal, an average of 7 days

• Early detection of anastomotic leak (days from surgery to diagnosis)

  Time to anastomotic leak, assessed up to 90 days after surgery

• Interval between anastomotic leak diagnosis and reoperation (hours)

  Time from leak diagnosis to reoperation, assessed up to 30 days after leak diagnosis

Study Arms (2)

Conventional drain insertion

ACTIVE COMPARATOR

Participants undergo standard transperitoneal pelvic drain placement following anterior or low anterior resection.

Procedure: Conventional drain insertion

EPT drain fixation

EXPERIMENTAL

Participants undergo pelvic drain placement using the extra-peritoneal tunneling (EPT) method following anterior or low anterior resection.

Procedure: EPT drain fixation

Interventions

EPT drain fixation PROCEDURE

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

EPT drain fixation

Conventional drain insertion PROCEDURE

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

Conventional drain insertion

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo rectal resection (anterior resection or low anterior resection) with planned intraoperative drain placement.
• Expected anastomotic level ≤10 cm from the anal verge based on preoperative imaging or endoscopic evaluation.

You may not qualify if:

• Patients scheduled to undergo additional colonic resection (e.g., right hemicolectomy, transverse colectomy).
• Patients in whom no intraoperative drain placement is planned.
• Patients scheduled for permanent or end stoma formation (e.g., abdominoperineal resection or Hartmann's procedure).
• Patients with prior pelvic surgery (e.g., hysterectomy, prostatectomy, pelvic lymph node dissection) that may cause pelvic adhesions or anatomic distortion.
• Patients with ASA physical status IV or severe systemic disease expected to require postoperative intensive care unit (ICU) admission.
• Patients who decline to provide informed consent for study participation

Sponsors & Collaborators

• Yeungnam University Hospital: lead
• Konyang University Hospital: collaborator
• Daegu Catholic University Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Chungnam National University Hospital: collaborator
• Chungbuk National University Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Chonbuk National University Hospital: collaborator
• Kyungpook National University Chilgok Hospital: collaborator
• Yonsei University Yongin Severance Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Ewha Womans University Seoul Hospital: collaborator
• Soonchunhyang University Hospital: collaborator
• Hallym University Dongtan Sacred Heart Hospital: collaborator

Study Sites (1)

Sung Il Kang

Daegu, South Korea

Location

MeSH Terms

Conditions

Rectal Diseases; Sigmoid Diseases; Rectal Neoplasms; Sigmoid Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Neoplasms

Study Officials

• SUNG IL KANG, M.D., Ph.D.

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUNG IL KANG, M.D., Ph.D.

CONTACT

+82-10-9124-5085; sungiry@naver.com

Jihye Lee

CONTACT

+82-53-620-3580; sungiry@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All enrolled patients will undergo the same standard surgical and postoperative management, except for the method of drain placement. No masking will be applied because the surgical procedure is visibly different and performed intraoperatively. The trial will follow participants through postoperative recovery until drain removal and hospital discharge, with standardized imaging to assess drain position and detect anastomotic leakage. This design allows for direct comparison of efficacy and safety outcomes between the two techniques in real-world surgical settings.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a parallel-group, randomized controlled design to compare two surgical techniques for pelvic drain insertion following anterior or low anterior resection for rectal cancer. Participants will be randomly assigned in a 1:1 ratio to either the extra-peritoneal tunneling (EPT) drain fixation group or the conventional drain insertion group. Randomization will be stratified by sex, preoperative chemoradiation status, and the anastomotic level relative to the peritoneal reflection to ensure balanced distribution of clinical factors.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

KR (1)