Phase 3
Completed N=40
Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin
Intraoperative Complications · Thermal Injury · Electrocoagulation
Source: ClinicalTrials.gov NCT01664806 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Histologic Thermal Injury to Epigastric Port Site Skin — 1; 7 participants
Summary
Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997) 11:653] Authors have speculated that using different generator modes may lead to less capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support these speculations.
The investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histologic Thermal Injury to Epigastric Port Site Skin |
1; 7 | — |
| SECONDARY Histologic Evidence of Burn at the Umbilical Port Site Skin |
3; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years and older planned to undergo elective laparoscopic cholecystectomy
Exclusion Criteria
- Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
Data sourced from ClinicalTrials.gov (NCT01664806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.