Disposable Intestinal Isolation and Protection Device for Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
A Randomized, Controlled, Open Multicenter Clinical Study on the Efficacy and Safety of a Disposable Intestinal Isolation Protective Device in Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
The small intestine is the main organ in the abdominal cavity, approximately 4 to 5 meters in length, occupying most of the middle and lower abdomen. Due to the long mesentery of the small intestine, it is in a free state and has a high degree of mobility. When performing abdominal surgery, especially lower abdominal surgery, the freedom and slippability of the small intestine often affect the exposure of the surgical site and the operating field of vision. Lower abdominal surgery generally includes colorectal surgery, gynecological surgery, urological surgery, etc. At present, in clinical practice, open surgeries, including minimally invasive laparoscopic manual surgeries, mainly involve significantly adjusting the patient's position to slide the small intestine into the surgical field, or simply surrounding and covering the small intestine with gauze pads and assisting in pulling with the help of assistants. However, the results are not satisfactory, especially for obese patients.
In the current clinical practice of performing middle and lower abdominal surgeries, especially laparoscopic surgeries, a device superior to gauze isolation pads is needed. It can separate the small intestine from the surgical site to expose the surgical area, facilitating doctors to perform manual operations calmly and reducing the operation time and complications. Avoid the special position with the head low and the feet high, which may increase the risk of restricted cardiac and respiratory functions in patients and reduce the impact on surgical anesthesia.
To collect more data on the efficacy and safety of this product for abdominal surgery, it is planned to conduct this post-market clinical study. This clinical study will adhere to the Good Clinical Practice for Medical Devices and relevant laws and regulations, and strictly implement the clinical research protocol.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Xicheng Dis
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Beijing, Xicheng Dis, China, 100050
- Beijing Friendship hospital, Capital Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional gauze group
Conventional surgery method
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sterile gauze
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Experimental: Intestinal devrce group
Operate using specialized equipment
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The TPYRIB type is composed of a separator bag, a binding film, a tightening sleeve, a push rod handle, a push rod, an outer sleeve, an outer sleeve handle, a hook and a spring clip, a puncture needle, a fixing plate and a pull hook.
The TPYRIS type is composed of an outer sleeve cap, a spacer bag, an expansion ring, a pull rod, a push rod handle, a push rod, an outer sleeve, an outer sleeve handle, a hook and a retaining ring, and a fixed block.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The main efficacy evaluation index: During the surgery.
Time Frame: The subject visit windows are set as follows: Screening period: -7 days, i.e., within 7 days before the surgery Treatment period: 0 days, on the day of the surgery Observation period: 1-7 days after the surgery (including 7 days after the surgery) Follow
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Evaluation method: Treatment group: The time from opening and starting to use the disposable small intestinal isolation protection device to completing the retrieval of the disposable small intestinal isolation bag.
Control group: From the first time the gauze is opened and used to the time when the last piece of gauze is retrieved.
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The subject visit windows are set as follows: Screening period: -7 days, i.e., within 7 days before the surgery Treatment period: 0 days, on the day of the surgery Observation period: 1-7 days after the surgery (including 7 days after the surgery) Follow
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of equipment usage
Time Frame: From the time of enrollment until the end of the 3-month treatment period.
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On the day of the surgery (within 24 hours), the researchers evaluated the ease of use of the product during open surgery and laparoscopic surgery, whether there was accidental injury to surrounding organs, whether the surgical field was satisfactory, and whether multiple isolations were required.
Use a 5-point scale (0 for light, 5 for heavy, in ascending order).
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From the time of enrollment until the end of the 3-month treatment period.
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Surgical Position Record
Time Frame: From the time of enrollment until the end of the 3-month treatment period.
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On the day of surgery (within 24h), the researcher adjusted the body position according to the intraoperative requirements, which was supine, within 15° (0-15° including 15°), 15-30 ° (15°-30° including 30°), and more than 30° (greater than 30°).
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From the time of enrollment until the end of the 3-month treatment period.
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First exhaust time
Time Frame: From the time of enrollment until the end of the 3-month treatment period.
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Starting from the day of the surgery, record the duration (eg.
12h-24 m, HH-MM) of the first time the patient passed gas after the surgery.
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From the time of enrollment until the end of the 3-month treatment period.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ZHONGTAO ZHANG, Doctor, Beijing Friendship Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BFH-XCGL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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