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.
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.
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.
- Conditions
- Colorectal Cancer, Adhesion
- 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 group | Role | What 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.
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)
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.
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.
Blood loss
The intraoperative blood loss was recorded in mL.
Measured: About 3-4 hours
Operation time
The operation time was recorded in minutes.
Measured: About 3-4 hours
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
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
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.
- First posted21 Aug 2023
- Study start4 Aug 2023
- Primary completion10 Aug 2023
- Study completion13 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Tung LIANG, Study chair, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Patterns and Surgical Outcomes for Mechanical Ileus in the Era of Minimally Invasive Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05999162
- Acronym / sponsor ID
- 202306117RINA
- Conditions
- Colorectal Cancer, Adhesion
- Keywords
- adhesive ileus, internal herniation, colorectal cancer, minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,544 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 13 Aug 2023 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgery (MIS) | – | Procedure: Minimally invasive surgeryThe patients underwent minimally invasive surgery for the treatment of colorectal cancer. |
| Traditional open surgery (TOS) | – | –The patients underwent traditional open surgery for the treatment of colorectal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who diagnosed as colorectal cancer and underwent curative intent surgery
Key inclusion criteria (1 listed)
- patients whose primary colorectal cancers were resected in the fashion of curative and elective surgery.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgeryMinimally invasive surgery includes laparoscopic surgery or robotic surgery for the treatment of colorectal surgery. | Procedure or surgery | Minimally invasive surgery (MIS) |
Primary outcome
Onset time
Time frame: Follow up period about five years with a median of 38.5 months.
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.
7 secondary outcomes
The pattern of adhesion
Time frame: Follow up period about five years with a median of 38.5 months.
The surgery of adhesive ileus
Time frame: Follow up period about five years with a median of 38.5 months.
Blood loss
Time frame: About 3-4 hours
Operation time
Time frame: About 3-4 hours
Surgical complication
Time frame: Within 30 days
Hospitalization
Time frame: About 7-10 days
Re-admission
Time frame: Within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tung LIANG study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.