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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02870556
Other study ID # Not yet assigned
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 20, 2016
Est. completion date December 10, 2019

Study information

Verified date February 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pharyngocutaneous fistula (PCF) is the most commonly reported postoperative complication in total laryngectomy patients. PCF significantly increases morbidity, length of hospitalization, and cost of care, in addition to delaying the beginning of adjuvant therapy. The reported incidence of PCF ranges from 3% to 65%.The increased use of radiation in the primary management of laryngeal carcinoma has resulted in an increase in the PCF formation after salvage laryngectomy (STL).

Previously reported risk factors for PCF development include preoperative radiotherapy, tumor stage, concomitant neck dissection, prior need for tracheotomy, hypoalbuminemia and anemia.

Among surgical options, the pectoralis major myofascial flap has been proposed to cover the pharyngeal closure, to interpose non-irradiated tissue between the neopharynx and the skin during STL. Nonetheless, the efficacy of this approach is not fully established.Epidural anesthesia improves the blood supply due to its vasodilating effect. The aim of the study is to evaluate the effect of perioperative cervical epidural analgesia on the occurrence of pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap.


Description:

Patients will be divided into two equal groups, group (EP), will receive perioperative cervical epidural analgesia in addition to general anesthesia and group (GA) will receive general anesthesia and postoperative analgesia through patient controlled intravenous morphine analgesia (PCA), that involve 1 mg continuous infusion and 2 mg boluses with lockout interval 10 min.

Cervical epidural technique: epidural needle will be inserted at C 6-C7 or C7-T1 under fluoroscopy in prone position, 6 ml of 0.125% bupivacaine and fentanyl 2 mic/ ml will be administered before skin incision followed by 4 ml of the same injectate, will be infused continously for 2 days


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date December 10, 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who failed treatment with radiotherapy for laryngeal cancer

Exclusion Criteria:

1. Infection at the site of flap

2. Primary laryngectomy without radiotheraapy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
cervical epidural analgesia


Locations

Country Name City State
Egypt Diab Assiut Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary pharyngocutaneous fistula following salvage laryngectomy and reconstruction with pectoralis major myocutaneous flap 2 weeks postoperatively
Secondary Pain intensity measured by visual analogue scale (VAS) 0 h (immediately postoperative), 2h, 6h, 12h, 24h, 48h (postoperatively
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