Mechanical Ileus in the Era of Minimally Invasive Colorectal Surgery

NCT05999162 | Completed

• 1 other identifier: 202306117RINA
• Study Type: observational
• Target: 1,544
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was to investigate if the incidence, patterns and surgical outcomes of mechanical ileus have changed in the era of minimally invasive surgery (MIS).

Conditions

Colorectal Cancer; Adhesion

Keywords

adhesive ileus; internal herniation; colorectal cancer; minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• Onset time

  Patients with mechanical ileus were stratified as acute, early, intermediate, and late onset, according to whether the mechanical ileus occurred within 3 months, 3-12 months, 1-2 years, or more than 2 years after the primary surgery for colorectal cancer, respectively.

  Follow up period about five years with a median of 38.5 months.

Secondary Outcomes (7)

• The pattern of adhesion

  Follow up period about five years with a median of 38.5 months.

• The surgery of adhesive ileus

  Follow up period about five years with a median of 38.5 months.

• Blood loss

  About 3-4 hours

• Operation time

  About 3-4 hours

• Surgical complication

  Within 30 days

Study Arms (2)

Minimally invasive surgery (MIS)

The patients underwent minimally invasive surgery for the treatment of colorectal cancer.

Procedure: Minimally invasive surgery

Traditional open surgery (TOS)

The patients underwent traditional open surgery for the treatment of colorectal cancer.

Interventions

Minimally invasive surgery PROCEDURE

Minimally invasive surgery includes laparoscopic surgery or robotic surgery for the treatment of colorectal surgery.

Minimally invasive surgery (MIS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who diagnosed as colorectal cancer and underwent curative intent surgery

You may qualify if:

• patients whose primary colorectal cancers were resected in the fashion of curative and elective surgery.

You may not qualify if:

• patients who underwent palliative or emergency surgery to treat their primary colorectal cancer;
• patients encountered anastomotic leakage, intra-abdominal abscess or the other surgical complications requiring an additional abdominopelvic surgical or non-surgical procedures to treat the complications;
• simultaneously underwent some other abdominal or pelvic surgical procedures before or after the primary colorectal surgery, e.g., reverse Hartmann's procedure or closure of the temporary colostoma.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Tissue Adhesions

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Jin-Tung LIANG

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: August 4, 2023
• Primary Completion: August 10, 2023
• Study Completion: August 13, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

TW (1)