NCT06015399

Methods of Establishing Intersegmental Plane in Segmentectomy

Methods of Establishing Intersegmental Plane in Segmentectomy: a Prospective Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy.

Detailed description

This is a single-center, prospective, randomized controlled study. A total of 200 subjects undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are randomly divided into closed insufflation group or dilatation and collapse group using a random number table generated by the computer, with 100 cases in each group. Intersegmental plane resolution grading, perioperative complications, operative time, intraoperative blood loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery will be extracted and compared between the groups.

Conditions

• Surgery

Interventions

Type	Name	Description
PROCEDURE	Implementation of closed insufflation technique during segmentectomy	After the identification the targeted segmental bronchus during the operation,ligating the proximal end of the targeted bronchus. Put the vessel separation forceps in the distal bronchial space to avoid the accidental damage of the vessels. Use a 50ml syringe to inject air into the distal bronchus (about 100ml is expected) until the intersegmental plane is satisfactory. Divide the target bronchus using the cutting and closing device.
PROCEDURE	Implementation of dilatation and collapse technique during segmentectomy	Divide the target bronchus using the cutting and closing device. Ask the anesthesiologist to inflate the lung completely from pure oxygen to the affected side and then change to single lung ventilation. Wait for the intersegmental plane to appear(usually about 15 minutes).

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-01
• Completion: 2026-03-01
• First posted: 2023-08-29
• Last updated: 2023-08-29

Locations

1 site across 1 country: China