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LigaSure

Electrosurgical bipolar vessel sealing using LigaSure versus conventional clamping and suturing for vaginal hysterectomy: a randomized controlled trial.

 

Go to the LigaSure website.



Objective
Hysterectomy is a commonly performed operation. The operation can be performed abdominally as well as vaginally. Recent investigation has shown lower post-operative pain scores and faster recovery till normal daily activities after abdominal hysterectomy with the help of LigaSure technique. This advantage might also be there after vaginal hysterectomy. Furhteron there are clues that through traction on the pelvine nerves vaginal hysterectomy might increase the risk of pelvic floor dysfunction compared to abdominal hysterectomy. Our hypothesis is that operation with LigaSure might diminish this risk through less lateral nerve damage and less traction on the nerves.
To randomly compare the effects of vessel sealing LigaSure on the operative parameters, post-operative pain and recovery and post-operative function of the pelvic floor in vaginal hysterectomy,

Study design
Randomized controlled trial

Study population
Women above the age of 18 years, undergoing a vaginal hysterectomy for benign diseases, excluding prolapse symptoms

Intervention
Vaginal hysterectomy with the help of LigaSure device or conventional technique.
 
Outcome measures
Pain score post-operatively as measured with the Visual analogue score.
Secondary outcome measures:
Surgery time, blood loss, hospital stay
Limitations in daily functioning the first six weeks after surgery
Pelvic floor function (micturition, defecation, sexual functioning)
Generic quality of life
Costs

Power/data analysis
A difference in postoperative pain of 15% (pain score of 40 vs 34) is considered to be clinically relevant. With a power of 90%, an alpha level of 0.05 and a standard deviation of 10 the calculated sample size necessary is 90 (45 in each group). Anticipating on a 10% drop out, we aim to include 100 patients (50 in each group)
Time schedule
Start inclusion April 2009 till April 2010

Project leaders
Dr. J.P. Roovers, gynaecologist, AMC Amsterdam
Drs. M.M.E. Lakeman, research physician, AMC Amsterdam
 
Contact
Drs. M.M.E. Lakeman, research physician,
AMC Amsterdam,
020-5669111 pager: 59627,
mail: ligasure@studies-obsgyn.nl