A bag that holds the small intestine could change colon surgery
NCT ID NCT07825129
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
During laparoscopic surgery on the rectum or lower sigmoid colon, the small intestine can slip into the operating area and block the surgeon's view. This trial tests a disposable isolation device that holds the small intestine away from the surgical site. Researchers compare the device with standard gauze packing in 140 patients with a BMI of 25 or higher. They measure how long it takes to set up and remove the device or gauze, and they check whether the device is easy to use and keeps the surgical field clear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a disposable intestinal isolation and protection device used during laparoscopic colorectal surgery
- What this could lead to
- If it works, surgeons could get a clearer view of the operating area without tilting patients head-down, which may shorten surgery and lower some anesthesia risks.
- What could go wrong
- This is a post-market study of a device, not a new drug, and it may not outperform standard gauze packing. Results in 140 patients may not apply to all surgeons or hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥22 years old, gender not limited. * Patients with rectal and lower sigmoid colon tumors who underwent laparoscopic AR/LAR surgery. * Patients with a BMI of ≥25 agreed to participate in this trial and signed the informed consent form. * The distance between the tumor and the anus as measured by enteroscopy should not exceed 20cm. Exclusion Criteria: * Female patients who have participated in or are currently participating in other clinical studies within 3 months before the operation, * Have acute infections, * Severe small intestinal adhesions or severe edema, * Severe abdominal adhesions, * Are known to be allergic to silicone, * Have a history of severe allergies or severe immune deficiencies, * Are pregnant or lactating. * The researcher judged that the patient had poor compliance and was unable to complete the study as required. * Due to cognitive impairment, I am unable to understand the researcher's introduction or explanation of this trial. * Those who have undergone previous intestinal or pelvic surgery. * Tissues removed during surgery, including those with sharp or pointed edges, such as broken bone fragments, are not suitable for use with this instrument.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, 100050, China
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Other studies related to the condition(s) this trial covers.