Semi-mechanical versus hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for esophageal cancer; the SHARE study

Phase 3

Completed

• Conditions: esophageal cancer; esophageal carcinoma; 10017943; 10017991; 10017998

• Registration Number: NL-OMON35934
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

* Esophageal resection with stomach tube reconstruction for esophageal carcinoma
* Signed informed consent
* Availability for 1 year follow-up in the Erasmus Medical Center
* Age over 18 year

Exclusion Criteria

* Other forms of esophageal reconstruction than a stomach tube.
* Classification of American Society of Anaesthesiologists over or equal to 4.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint: clinical anastomotic leakage defined by neck<br /><br>wound infection and loss of saliva and/or fluids through the wound site, signs<br /><br>of mediastinitis or abcess intrathoracic or leakage confirmed by radiological<br /><br>examination (endoscopy or CT with contrast fluids) after clinical suspicion<br /><br>(i.e. leucocytosis, fever, pain), all within 30 days after operation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints: anastomotic stricture within one year,<br /><br>number of dilations within one year, dysphagia score (table 1, score by<br /><br>Sugahara), quality of life measured by EORTC QLQ C-30 and OES-18 questionnaires<br /><br>preoperative and at 3, 6, 9 and 12 months after surgery. </p><br>