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,
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain score post-operatively as measured with the Visual analoge score.
Secondary outcome
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
Background summary
Hysterectomy is a commonly performed operation. The operation can be performed
abdominally as well as vaginally. Recent investigation has shown lower
post-operative painscores and faster recovery till normaldaily 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.
Study objective
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
Randomised controlled trial
Intervention
One group of patients undergo vaginal hysterectomy with the help of LigaSure
device. The other patients undergo vaginal hysterectomy according to the
conventional technique.
Study burden and risks
Patients are asked to fill out a questionnaire before operation, six weeks and
six months after operation. And a daily questionnaire till two weeks after
operation. This takes mostly 2 hours time spread in 6 months.
There are no risks at operating with LigaSure technique.
Meibergdreef 9
1105AZ Amsterdam
Nederland
Meibergdreef 9
1105AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
women, age above 18 years, undergoing vaginal hysterectomy for benign diseases
Exclusion criteria
Patients undergoing vaginal hysterectomy for treatment of symptomatic genital prolapse.
Patients undergoing concomitant surgical procedures
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26335.018.08 |