Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen

NCT ID: NCT04917367

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2026-12-30

Brief Summary

Objective: To improve the success rate of the treatment of migrating foreign bodies in the upper aerodigestive tract.

Methods: The medical records of inpatients conforming to the diagnosis of migrating foreign bodies between 2020 and 2025 were reviewed. Data regarding age, gender, time from onset to hospitalization, computed tomography (CT) and endoscopic scans, surgical procedures，and follow-up were collected.

Conditions

Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Conventional surgery group

Conventional surgery with Preoperative foreign body localization

exploratory surgery

Intervention Type: PROCEDURE

For foreign bodies in the retropharyngeal space or parapharyngeal space above the esophageal entrance, close to the laryngopharynx cavity with large operating space, suspension laryngoscopy is the first choice according to the principle of proximity. In all cases, a lateral cleft laryngoscope was used to expose the posterior or lateral wall of the laryngopharynx, and 30° endoscope or microscope was used according to the skills of the surgeon.

For a foreign body below the esophageal entrance, the lateral cervical incision was the first choice due to the small operating space of oral exposure. The lateral cervical incision and other open surgical methods are used for foreign bodies below the entrance of the esophagus or in the submaxillary space or for the anterior cervical band muscle foreign bodies.

New surgery group

new surgery with Intraoperative localization of foreign body

exploratory surgery

Intervention Type: PROCEDURE

For foreign bodies in the retropharyngeal space or parapharyngeal space above the esophageal entrance, close to the laryngopharynx cavity with large operating space, suspension laryngoscopy is the first choice according to the principle of proximity. In all cases, a lateral cleft laryngoscope was used to expose the posterior or lateral wall of the laryngopharynx, and 30° endoscope or microscope was used according to the skills of the surgeon.

For a foreign body below the esophageal entrance, the lateral cervical incision was the first choice due to the small operating space of oral exposure. The lateral cervical incision and other open surgical methods are used for foreign bodies below the entrance of the esophagus or in the submaxillary space or for the anterior cervical band muscle foreign bodies.

Interventions

exploratory surgery

For foreign bodies in the retropharyngeal space or parapharyngeal space above the esophageal entrance, close to the laryngopharynx cavity with large operating space, suspension laryngoscopy is the first choice according to the principle of proximity. In all cases, a lateral cleft laryngoscope was used to expose the posterior or lateral wall of the laryngopharynx, and 30° endoscope or microscope was used according to the skills of the surgeon.

For a foreign body below the esophageal entrance, the lateral cervical incision was the first choice due to the small operating space of oral exposure. The lateral cervical incision and other open surgical methods are used for foreign bodies below the entrance of the esophagus or in the submaxillary space or for the anterior cervical band muscle foreign bodies.

Intervention Type: PROCEDURE

Other Intervention Names

lateral cervical incision surgery

Eligibility Criteria

Inclusion Criteria

• The foreign body of pharynx or esophagus was confirmed by surgical exploration

Exclusion Criteria

• The foreign body is in the pharynx or esophagus or is not found during surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong-Gang Duan, doctor

Role: STUDY_DIRECTOR

Second Affiliated Hospital, College of Medicine, Zhejiang University

Locations

Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong-Gang Duan, doctor

Role: CONTACT

2314061@zju.edu.cn

86(China)-571-87783774

Fang Ji, master

Role: CONTACT

1506061@zju.edu.cn

86(China)-571-87783774

Facility Contacts

Hong-Gang Duan, doctor

Role: primary

2314061@zju.edu.cn

86(China)-571-87783774

Other Identifiers

2020-152

Identifier Type: -

Identifier Source: org_study_id