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NCT Number: NCT05999162

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Minimally Invasive Surgery

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. The pattern of adhesion

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

    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)

  2. The surgery of adhesive ileus

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

    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.

  3. Blood loss

    Time frame: About 3-4 hours

    The intraoperative blood loss was recorded in mL.

  4. Operation time

    Time frame: About 3-4 hours

    The operation time was recorded in minutes.

  5. Surgical complication

    Time frame: Within 30 days

    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.

  6. Hospitalization

    Time frame: About 7-10 days

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

  7. Re-admission

    Time frame: Within 30 days

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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