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Colorectal CancerNCT05999162

Mechanical Ileus in the Era of Minimally Invasive Colorectal Surgery

An observational study of Colorectal Cancer and Adhesion, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Adhesion
What is being tested?
Minimally invasive surgery
Type of treatment
Surgery or procedure
How many people
1,544 participants
Where
1 siteTaiwan
Study dates
4 Aug 2023to 13 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Changing Patterns and Surgical Outcomes for Mechanical Ileus in the Era of Minimally Invasive Colorectal Surgery

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).

Read the detailed description

Mechanical ileus, generally caused by post-operative bowel adhesion, represented 12-16% of emergency surgical admissions and 20% of emergency surgical procedures. Opening the peritoneal cavity, in whatever type of surgery, leads to the formation of potentially obstructive structures (adhesions or bands) in almost 95% of patients. The adhesion resulted from the irritation of the peritoneum caused by surgical trauma or intra-abdominal infection. Bowel adhesions can lead to clinical manifestations within a few weeks or even several years after the surgery. It has been reported that traditional open surgery (TOS) for colorectal cancer were associated with a particularly higher risk of adhesion formation and related complications. Within two years after colorectal surgery, 14.3% of the patients will suffer from small bowel obstruction, and 2.6% will require a surgical intervention for the treatment of this obstruction, and this incidence is even higher after rectal surgery. Adhesive ileus has been a clinical conundrum. Overall, nearly one-fifth of patients needed re-admission for a recurrent disease, even they had been successfully treated by surgical, or non-surgical methods during the index admission.

During the last decade, minimally invasive surgery (MIS), either via laparoscopic or robotic approach, has become the standard procedures for the treatment of colorectal cancer. Theoretically, MIS is associated with a much lower rate of postoperative formation of adhesions than TOB, since adhesion formation represents a stepwise failure of peritoneal tissue repair mechanisms, which can be prevented by the clean dissection, minimal blood loss and/or less-environmental exposure of the bowel inherent in MIS. Some researchers supported this concept by showing MIS colorectal surgery is associated with fewer adhesion-related admissions than open surgery. However, most reported case series were retrospective uncontrolled studies and were liable to some uncertainty; even in some rare randomized controlled trials, the conclusions were contradictory. Moreover, adhesive ileus is just one variant of mechanical ileus; some researchers have pointed out the MIS can paradoxically create some specific types of mechanical ileus, such as internal or external herniation of small intestine, or bowel twisting over the anastomotic site, and so on. Therefore, it remains unclear whether MIS colorectal resection can reduce the incidence of the mechanical ileus and improve the long-term bowel function, as compared with the TOS.

Considering the aforementioned reasons, we conducted the present study to investigate if the incidence, patterns and the treatment outcomes of post-operative mechanical ileus changed in the era of MIS for colorectal cancer.

Being tested
Minimally invasive surgery
Keywords
adhesive ileus, internal herniation, colorectal cancer, minimally invasive surgery
Medical subject headings
Colorectal Neoplasms, Tissue Adhesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimally invasive surgeryProcedure or surgery

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

Study groups in NCT05999162
Study groupRoleWhat they receive
Minimally invasive surgery (MIS)The patients underwent minimally invasive surgery for the treatment of colorectal cancer.
Receives: Procedure: Minimally invasive surgery
Traditional open surgery (TOS)The patients underwent traditional open surgery for the treatment of colorectal cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  1. The pattern of adhesion

    The pattern of adhesion may be recorded as follows: bands (>1 cm long and <1 cm diameter); simple adhesions (<1 cm long and >1 cm diameter) or matted adhesion (dense, multiple, and tangled)

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

  2. The surgery of adhesive ileus

    The surgery for treating ileus may be recorded as follows: 1) band section; 2) lysis of simple adhesion; 3) lysis of matted adhesion; 4) extensive adhesiolysis, sutured or not serosal defect or sutured accidental enterotomies; or 5) even the segmental bowel resection in addition to whatever the previously mentioned procedures.

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

  3. Blood loss

    The intraoperative blood loss was recorded in mL.

    Measured: About 3-4 hours

  4. Operation time

    The operation time was recorded in minutes.

    Measured: About 3-4 hours

  5. Surgical complication

    The Clavien-Dindo classification system was used to score the severity of surgical complications. The Clavien-Dindo Classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The higher the grade, the severer the complication.

    Measured: Within 30 days

  6. Hospitalization

    The length of hospital stay was calculated from the date of surgery for mechanical ileus to the day of discharge from the hospital.

    Measured: About 7-10 days

  7. Re-admission

    The patient needs to be readmitted to hospital due to index surgery.

    Measured: Within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start4 Aug 2023
  3. Primary completion10 Aug 2023
  4. Study completion13 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05999162
Sponsor's protocol ID
202306117RINA
Status last verified
Aug 2023
First submitted
13 Aug 2023
Last updated
21 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Adhesion, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset time (time frame: Follow up period about five years with a median of 38.5 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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