Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04917367

Collaborator

(none)

Enrollment

Location

65.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery	Procedure: exploratory surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Second Affiliated Hospital, College of Medicine, Zhejiang University

Actual Study Start Date :

Jul 2, 2021

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Conventional surgery group Conventional surgery with Preoperative foreign body localization	Procedure: 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. Other Names: lateral cervical incision surgery
New surgery group new surgery with Intraoperative localization of foreign body	Procedure: 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. Other Names: lateral cervical incision surgery

Arm

Intervention/Treatment

Conventional surgery group

Conventional surgery with Preoperative foreign body localization

Procedure: 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.

Other Names:

lateral cervical incision surgery

New surgery group

new surgery with Intraoperative localization of foreign body

Procedure: exploratory surgery

Other Names:

lateral cervical incision surgery

Outcome Measures

Primary Outcome Measures

Success rate [5 years]
Success rate of two groups

Secondary Outcome Measures

surgery time [intraoperative]
Surgery time of two groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Director: Hong-Gang Duan, doctor, Second Affiliated Hospital, College of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04917367

Other Study ID Numbers:

2020-152

First Posted:

Jun 8, 2021

Last Update Posted:

Mar 24, 2022

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

Migrating foreign body; Upper aerodigestive tract; Neck; Laryngoscopy endoscopy; Positioning

Additional relevant MeSH terms:

Foreign Bodies

Study Results

No Results Posted as of Mar 24, 2022