Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen

NCT04917367 | Recruiting

• 1 other identifier: 2020-152
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Success rate

  Success rate of two groups

  5 years

Secondary Outcomes (1)

• surgery time

  intraoperative

Study Arms (2)

Conventional surgery group

Conventional surgery with Preoperative foreign body localization

Procedure: exploratory surgery

New surgery group

new surgery with Intraoperative localization of foreign body

Procedure: exploratory surgery

Interventions

exploratory surgery 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.

Also known as: lateral cervical incision surgery

Conventional surgery group; New surgery group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People from vulnerable groups are excluded

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Hong-Gang Duan, doctor

  Second Affiliated Hospital, College of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Hong-Gang Duan, doctor

CONTACT

86(China)-571-87783774; 2314061@zju.edu.cn

Fang Ji, master

CONTACT

86(China)-571-87783774; 1506061@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: July 2, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 24, 2022

Record last verified: 2021-06

Locations

CN (1)