NCT06924515

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Dec 2024Jun 2026

Study Start

First participant enrolled

December 24, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2026

Expected
Last Updated

February 2, 2026

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 5, 2025

Last Update Submit

January 30, 2026

Conditions

Keywords

lung herniaVATS

Outcome Measures

Primary Outcomes (2)

  • Postoperative chest CT 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.

    From enrollment to the end of treatment at 3 months

  • Hemostasis time

    Record the bleeding condition at the intercostal incision. If there is bleeding at the intercostal incision, record the hemostasis time in detail.

    From enrollment to the end of surgery

Secondary Outcomes (1)

  • Postoperative drainage volume within 3 days

    Postoperative Day 1,Day 2,Day 3

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Procedure: Intercostal suture

Control group

NO INTERVENTION

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.

Interventions

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。

Experimental group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing lung resection via multiport thoracoscopic surgery
  • Age greater than or equal to 18 years
  • No history of thoracic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician;Professor

Study Record Dates

First Submitted

April 5, 2025

First Posted

April 11, 2025

Study Start

December 24, 2024

Primary Completion

April 30, 2026

Study Completion (Estimated)

June 28, 2026

Last Updated

February 2, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations