Clinical Trials Logo

Clinical Trial Summary

In this study, the investigators aim to present fifteen years' experience of thoracoscopic sympathetic chain interruption for primary palmar hyperhidrosis in children and adolescents; evaluation of 3 different techniques (sympathectomy, sympathotomy, and clipping) regarding demographic data, surgical outcomes, complications, compensatory sweating, and patients' satisfaction.


Clinical Trial Description

Primary palmar hyperhidrosis (PPH) is a severely devastating autonomic disorder that can affect any patient regardless age, even pediatrics. Thoracoscopic sympathetic chain interruption offers a definitive effective therapy. In this study, the investigators aim to assess the outcomes of thoracoscopic management of palmar hyperhidrosis in a large cohort of children younger than 18 years old with severe PPH, using sympathetic chain interruption either by sympathectomy, sympathotomy or clipping, to provide a methodology focused on the long-term outcomes of those procedures. Patients and Methods: This is a retrospective study that included all children who underwent thoracoscopic sympathectomy, sympathotomy, or clipping for severe PPH, from April 2008 to March 2023 were assessed retrospectively. Demographic data, postoperative outcome, complications, compensatory sweating and satisfaction were analyzed. Surgical procedures: General anesthesia was used, with an ordinary endotracheal tube, by an experienced anesthesiologist who used one lung ventilation anesthesia to control the patient's O2-enriched ventilation in a low-volume/high-frequency technique, with alternating brief periods of apnea. The patient was placed in the semi-Fowler position, which is the dorsal decubitus position with the arms abducted and fixed at 90 degrees. The trunk was elevated by 30-40 degrees; as elevation helped displace the lungs downwards. A slight bed elevation at the knee level was useful to safely place the patients and prevent them from slipping down during the procedure. To access the thoracic cavity, the investigators used the two-port video thoracoscopy using two 5 mm ports via 2 mini-incisions. The camera (30º scope) port was placed laterally at the fourth or fifth intercostal space (depending on the age of the patient) just posterior to the anterior axillary fold created by the pectoralis major muscle. The second port (for electrocautery instrument (hook) was laterally inserted in the third/fourth intercostal space at the mid-axillary line as that approach provides excellent aesthetic results. A CO2 pneumothorax pressure of 5-8 mmHg was used according to patient's age and body built. The posterior parietal pleura was incised just lateral to neck of 3rd rib and further dissected down to identify the thoracic sympathetic chain. A-Thoracoscopic sympathectomy: A segment of the thoracic sympathetic chain at the intended levels is resected using hook electrothermoablation. B-Thoracoscopic sympathotomy technique (VATS): The sympathetic chain is just cut at the desired levels without excision. C-Thoracoscopic clipping technique: Titanium clips are applied on the desired level without cutting. Then, after completion of the procedure, CO2 pneumothorax was deflated, permitting full lung inflation under vision, without need for chest tube placement, ports removal, and port-sites closure by absorbable sutures with full awake recovery from anesthesia. Post operative routine chest x-ray was done to detect any residual pneumothorax and to assess the location of clips in clipping group. Statistical Analysis: Data were collected, revised, coded, and entered to the Statistical Package for Social Science (SPSS), IBM, version 23. The qualitative data were presented as numbers and percentages, while the quantitative data were presented as means, standard deviations, and ranges when their distribution was found to be parametric. Independent t-test and Chi-square tests were used to compare both groups. The p-value was considered significant if < 0.05. Discussion: will explore the different treatment modalities for PPH in children and adolescents, mentioning the medical/conservative methods, then focusing on the surgical option, that is thoracoscopic sympathetic chain interruption, either by sympathectomy, sympathotomy, and clipping for almost permanent remedy of PPH in pediatric age group younger than 18 years old. Points of discussion will include demographic data, follow-up period, surgical outcomes and complications, compensatory sweating, and patients' satisfaction.. The results obtained will be compared among the 3 groups and also compared to the previously published articles. Finally, the investigators will conclude whether or not there is a better technique among the 3 modalities that gives the best durable outcome with the least complications. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06113978
Study type Interventional
Source Al-Azhar University
Contact
Status Completed
Phase N/A
Start date September 1, 2022
Completion date August 30, 2023

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT04178161 - Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis N/A
Completed NCT02552199 - A Non-Interventional Study To Assess Sweating
Completed NCT02565732 - Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis Phase 2
Recruiting NCT01930604 - Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis Phase 2
Completed NCT01811004 - Evaluation of 1440nm Laser vs. Botulinum Toxin or miraDry® Microwave For Treatment of Axillary Hyperhidrosis N/A
Completed NCT01671800 - Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating Phase 1
Completed NCT01956591 - Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis N/A
Completed NCT01934153 - Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects Phase 1
Not yet recruiting NCT05102396 - Topical Oxybutynin for Treatment of Hyperidrosis: a Local or a Systemic Effect? Phase 2
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Completed NCT04906655 - An Open Label Study for Palmar Hyperhydrosis Phase 2
Completed NCT02563899 - Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis Phase 2
Withdrawn NCT05546710 - miraDry Post Market Tumescent Anesthesia Study N/A
Completed NCT02016885 - A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis Phase 2
Completed NCT00168480 - A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis Phase 4
Completed NCT03416348 - Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2 Phase 1
Completed NCT02973659 - The Use of Topical Oxybutynin 10% for Treating Primary Focal Hyperhidrosis-axillary, Palmar and Plantar. N/A
Not yet recruiting NCT05805696 - Treatment and Mapping of Impostor Phenomenon N/A
Completed NCT03816046 - Hyperhydrosis Treatment Using Botulinum Toxin Phase 4