T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis

NCT01295853 | Completed DMC

• 1 other identifier: AMRO2345
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative compensatory hyperhydrosis

Conditions

Compensatory Hyperhidrosis; Recurrence

Outcome Measures

Primary Outcomes (1)

• postoperative compensatory hyperhidrosis

  CH remains the most common and distressing complication postsympathicotomy and many efforts have been made to ovoid its happening .Chou et al, 2 suggested that the underlying mechanism of CH may be due to a reflex response in sweating centre in hypothalamus but the exact mechanism beyond this phenomenon remain unclear.

  2008-2010

Secondary Outcomes (1)

• improvement of planter sweating assessment of overdry hands early postoperative complication ( pneumothorax,,,,,) recurrance

  2008-2010

Study Arms (2)

t3 sympathicotomy

ACTIVE COMPARATOR

The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.

Procedure: t3 sympathicotomy; Procedure: t4 symapthicotomy

t4 sypathicotomy

ACTIVE COMPARATOR

The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.

Procedure: t4 symapthicotomy

Interventions

t3 sympathicotomy PROCEDURE

The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.

Also known as: sympathectomy

t3 sympathicotomy

t4 symapthicotomy PROCEDURE

The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.

Also known as: sympathectomy

t3 sympathicotomy; t4 sypathicotomy

Eligibility Criteria

• Age: 15 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with primary palmar hyperhidrosis

You may not qualify if:

• Patients with pleural adhesion
• Bleeding diathesis
• Local infection
• Patients with certain anatomic anomalies

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Mansoura, 35111, Egypt

Location

Related Publications (1)

• Chou SH, Kao EL, Lin CC, Chang YT, Huang MF. The importance of classification in sympathetic surgery and a proposed mechanism for compensatory hyperhidrosis: experience with 464 cases. Surg Endosc. 2006 Nov;20(11):1749-53. doi: 10.1007/s00464-005-0829-7. Epub 2006 Oct 5.

  PMID: 17024534 BACKGROUND

MeSH Terms

Conditions

Recurrence

Interventions

Sympathectomy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Denervation; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• ahmed negm, md

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 15, 2011

Record last verified: 2008-02

Locations

EG (1)