- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06924515
The Application Value of Intercostal Suturing in Preventing Postoperative Thoracoscopic Lung Resection Chest Wall Pulmonary Hernia
January 30, 2026 updated by: Mingjian Ge
The purpose of this trial is to understand whether intercostal suture can effectively prevent postoperative chest wall lung herniation, mainly to verify the following questions Can intercostal suture reduce postoperative chest wall lung herniation The hemostatic effect and hemostatic time of intercostal suture on intercostal muscle incision bleeding during surgery The researchers will divide the participants into two groups, one group will receive intercostal suture, and the other group will not receive intercostal suture, that is, conventional suture The participants will Receive or not receive intercostal suture during surgery Hemostatic effect and hemostasis time of rib intermuscular incision bleeding during surgery Chest CT will be reviewed 3 months after surgery to observe the chest wall incision
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients undergoing lung resection via multiport thoracoscopic surgery
- Age greater than or equal to 18 years
- No history of thoracic surgery
Exclusion Criteria:
- Be converted to a thoracoscopic-assisted mini-thoracotomy,a rib retractor becomes necessary.
- Be converted to thoracotomy or a conventional posterolateral incision may be necessary based on the specific intraoperative circumstances.
- Uniportal thoracoscopic surgery
- History of ipsilateral thoracic surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
After the lung resection-related operations are completed, the chest cavity is properly hemostatic, and the incision protective cover of the relevant operation hole is removed.
If there is bleeding in the incision, use electrocoagulation to fully stop the bleeding.
After hemostasis is completed, use a ligature suture guide to clamp a 1-0 PDS absorbable suture and insert it into the upper intercostal space on the head side of the main operation port.
In the secondary operation space, use a double-jointed separation forceps to grasp the suture in the chest cavity and then detach the suture from the ligature suture guide.
At this time, insert the ligature suture guide into the lower intercostal space on the foot side of the main operation port.
The suture is clamped by the separation forceps in the chest cavity and then pulled out of the chest cavity after being clamped by the claws of the ligature suture guide.
In this way, continuous sutures are performed in sequence for a total of 5 s
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止血完成后使用结扎缝合引线器夹持1-0规格的PDS可吸收缝线在主操作口的头侧上一肋间穿入,于副操作空使用双关节分离钳在胸腔内抓持缝线后将缝线从结扎缝合引线器脱离,此时在主操作口足侧下一肋间穿入结扎缝合引线器,在胸腔内由分离钳夹持缝线经结扎缝合引线器钩爪夹持后将缝线牵拉出胸腔外,以此依次行连续缝合共5次缝合引线操作后拉拢缝线将主操作口闭合,打结结束缝合完成肋间肌及壁层胸膜的缝合。
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No Intervention: Control group
After the lung resection operation is completed, the chest cavity is properly hemostatic, and the incision protective cover of the relevant operation hole is removed.
If there is bleeding in the incision, electrocoagulation is used to fully stop the bleeding.
After the hemostasis is completed, the chest wall muscle group and subcutaneous tissue layer are sutured once with a double-needle barbed suture made of 2-gauge PDO material.
Finally, the skin is sutured with ordinary silk thread interrupted sutures or absorbable sutures are used to continuously suture the skin intradermally to complete the chest closure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative chest CT at 3 months
Time Frame: From enrollment to the end of treatment at 3 months
|
Postoperative follow-up chest CT:If the CT indicates that the lung tissue at the main incision site has herniated through the intercostal space to the outside of the rib bony structure,it is considered positive;otherwise,it is negative.
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From enrollment to the end of treatment at 3 months
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Hemostasis time
Time Frame: From enrollment to the end of surgery
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Record the bleeding condition at the intercostal incision.
If there is bleeding at the intercostal incision, record the hemostasis time in detail.
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From enrollment to the end of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative drainage volume within 3 days
Time Frame: Postoperative Day 1,Day 2,Day 3
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Record the volume of closed thoracic drainage every 24 hours,and document for 3 days postoperatively.
|
Postoperative Day 1,Day 2,Day 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 24, 2024
Primary Completion (Estimated)
April 30, 2026
Study Completion (Estimated)
June 28, 2026
Study Registration Dates
First Submitted
April 5, 2025
First Submitted That Met QC Criteria
April 5, 2025
First Posted (Actual)
April 11, 2025
Study Record Updates
Last Update Posted (Actual)
February 2, 2026
Last Update Submitted That Met QC Criteria
January 30, 2026
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-491-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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