Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202106614816344 Date of Approval: 21/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fluoroscopy guided bipolar radiofrequency ablation versus thoracoscopic thermocoagulation of T2 and T3 sympathetic ganglia in primary palmar hyperhidrosis patients
Official scientific title Fluoroscopy guided bipolar radiofrequency ablation versus thoracoscopic thermocoagulation of T2 and T3 sympathetic ganglia in primary palmar hyperhidrosis patients
Brief summary describing the background and objectives of the trial Introduction Primary hyperhidrosis is characterized by profuse sweating in absence of a stimulus. This differentiates it from secondary hyperhidrosis. Secondary hyperhidrosis is due to many causes for example malignancy, infection, medication, and anxiety disorder (Vorkamp et al., 2010). Although there are false impressions of female predominance. It usually affects males and females. Symptoms are bilateral and symmetrical. The episode starts with abrupt onset, profuse sweating that is maybe related to emotional stress. This usually interferes with the daily activities of the patients (Lear et al., 2007). Pneumothorax occurred frequently in the past (75%). nowadays the incidence decreased down to .4-2.3% due to new modalities in anesthesia such as double-lumen tube and one-lung ventilation. Surgical emphysema occurred up to 2.7% of the cases around the site of the trocar. Other complications such as atelectasis, lung injury, pleural effusion and bleeding and Horner syndrome have been described (Cameron. 2003). Most patients report sharp pain with deep inspiration postoperatively. Later, it may be aching pain in the back that require opiate analgesia (Gossot et al., 2001). Thoracic sympathetic ganglia extend from stellate ganglia to the 12th thoracic ganglia. They lie on the neck just lateral to the head of the corresponding rib. The T2 sympathetic ganglion is located anterior to the medial portion of the neck of the rib, whereas the ganglia from T3 through T6 are located in front of the heads of corresponding ribs. The T7 through T10 ganglia are located anterior to the radiate ligaments of the costovertebral joints (Stanton-Hicks and Management. 2001). Radiofrequency ablation of sympathetic ganglia from T2 to T4 is a good alternative to surgery. It is done under sedation and is a minimally invasive procedure, safe, inexpensive, and in the outpatient clinic. But its success rate is still lower than thoracoscopic sympathectomy (Garcia Franco et al., 2011, Purtuloglu et al., 2013). Anatomical variations that present in some patients are major causes of failure and patient satisfaction after thoracoscopic sympathectomy (McCormack et al., 2011). The sympathetic trunk mostly runs against the heads of ribs. but there is a variant in which it runs along the medial side of the heads. Another variant in which it runs between the neck and head (Stanton-Hicks et al., 2008). For years, we follow pain textbooks and do thermocoagulation of T2 and T3 sympathetic ganglia at the posterior third of T2 and T3 vertebral body with unsatisfactory results as compared by surgery. While the success rate of surgery that hit the sympathetic chain at the head and neck of the 2nd and 3rd rib is 97.8% (Rodríguez et al., 2008). To the best of our knowledge, there is only one paper that tried this optimum target versus old target (Khalifa and Hegab. 2017). In conventional monopolar radiofrequency ablation (MRFA) technique, the energy exists between the intervention needle tip and a grounding plate so the lesion size become small (Jadon, 2018). Bipolar radiofrequency energy is locally produced between the active and grounding electrodes on needle tip so the size of the lesion become larger than monopolar RF (Gulec, 2017). Aim of the work and hypothesis This prospective, randomized, open labelled controlled study is designed to compare the efficacy of thermocoagulation at the head and neck of the 2nd and 3rd ribs in the treatment of severe palmar hyperhidrosis and thoracoscopic sympathectomy. We hypothesize that targeting the head and neck of the 2nd and 3rd rib with percutaneous fluoroscopy-guided bipolar radiofrequency ablation of T2, T3 sympathetic ganglia in palmar hyperhidrosis will increase the efficacy of ablation in comparison to surgery without a significant increase in side effects to provide safe and effective method rather than surgery for hyperhidrosis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 14/07/2021
Actual trial start date 22/07/2021
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date 01/10/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Surgical sympathectomy Group Surgical sympathectomy Group (S) (30 patients): all patients in this group will have the standard surgical procedure. after induction of anesthesia All patients in this group will have a standard surgical procedure under general anesthesia with double-lumen endotracheal intubation or single lumen tube. After initiation of single-lung ventilation, a 1 cm incision will be made in the mid-axillary line at the fifth intercostal space. A 5 mm, 0° thoracoscope (Karl-Storz, Tutingen, Germany) is introduced into the pleural cavity through this incision. After general inspection and identification of the thoracic sympathetic trunk, an endoscopic cautery hook instrument will be introduced through the same incision. Cauterization of the sympathetic chain will be performed at the level T2 and T3 sympathectomy. Extensive cauterization will be carried out over the rib nearly 2 cm laterally to divide the accessory pathway. All procedures will be completed by re-inflation of the lung. The surgical wound was then closed. All cases will be performed bilaterally. In most cases (93%), patients will be discharged 24 h after the procedure. 30 Active-Treatment of Control Group
Experimental Group Bipolar radiofrequency ablation at the optimum target Group intraoperative Technique of radiofrequency ablation: Patients will be in the prone position; sterilized and draped, sedation will be given in the form of midazolam (0.1 mg/kg IV). C-arm will be centralized in posteroanterior position, endplate of T2; T3 will be aligned by cephalocaudal rotation then lateral tilt by about 10–15 degrees. After subcutaneous 5ml of local anesthetic infiltration (lidocaine 2%) and, under fluoroscopic guidance, radiofrequency cannula (10 cm length, 20 gauge size with 10 mm curved active tip) will be advanced to the T2; T3 sympathetic ganglion which lies at the head and neck of the 2nd and 3rd rib. Inadvertent puncture of the vertebral periosteum or disc induces local back pain, puncture of an intercostal nerve produces sudden pain along with the intercostal space, and violation of the pleura provokes cough. The level of the cannula will be tested by injection of radiopaque material over the parietal pleura. The contrast medium accumulates around the needle tip indicating the site. The occurrence of pneumothorax will be monitored through the abnormal spread of the contrast material. When the contrast medium spreads anteriorly into the posterior mediastinum, the needle has to be withdrawn a few mm, and diffusion of contrast medium is checked again. When the contrast medium extends into the vertebral canal or posteriorly along with the extrapleural space, the needle has to be advanced and its new position checked. After this test, the electrode of the RF device will be placed on the cannula. To check the position of the electrode neurophysiologically, negative sensory stimulation at 50 Hz and 0.4–0.7 V in addition to negative motor stimulation at 2 Hz and 1.3 –1.5V will be observed. After this neurophysiological testing, RF thermal coagulation will be applied at 80°C for 120 s against the head of the. The patient is asked to report any changes that he will experience in his upper limb. Usually, a sensation of heat is felt progressing from the arm down to the hand. The patient can locate graduate the sensation of warmth and dryness in his hand and fingers. Physical examination of the hand during the procedure confirms a rise in skin temperature and dryness. The patient is kept under observation in the PACU for one hour before discharge. Chest radiograph confirms the absence of local complications. Only one hand will be operated to avoid the possibility of the occurrence of bilateral complications as pneumothorax and also to avoid exhaustion of the operator that might affect his efficiency. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-patients of American Society of Anesthesiologists physical status I–II 2- of either sex 3-with their age ranging from 15 to 40 years 4- with severe palmar hyperhidrosis 1-history of clinically significant cardiac, hepatic, renal, or neurological dysfunction, coagulopathy 2- previously failed cases either after percutaneous or thoracoscopic sympathectomy. Adolescent: 13 Year-18 Year 15 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/03/2021 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street Mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The success rate with radiofrequency ablation assessed by temperature rise more than 3 degrees and dryness of the ipsilateral palm monthly for 6 months
Secondary Outcome • patient satisfaction. • postoperative pain. • amount of post-operative analgesic requirements. • occurrence of side effects as pneumothorax, transient Horner syndrome, and compensatory hyperhidrosis. monthly for 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Sayed Elemam 2 El-Gomhouria Street Mansoura 35516 Egypt
Khaled Ekbahrawy 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries Elsayed Elemam sayedemam0606@gmail.com +201008765995 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Nabil Mageed nabil_abelraouf@yahoo.com +201001538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide individual participant data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information