The primary objective of this study is to prove that a Total Laparoscopic Hysterectomy performed with sameday discharge is feasible and that it leads to equal levels of Quality of Life post-operative compared with one night admission.
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this RCT is the recovery and satisfaction after surgery,
measured with the Promis Physical Function - Short Form at 1, 3 and 7 days
post-operative. The quality of life will be measured at these same time points
by the EuroQol-5.
Secondary outcome
The secondary outcomes are the post-operative complications, operative
characteristics, duration of surgery, operating room occupancy, time to
discharge, time to first voiding, admission days, (re)admission, (re)
evaluation, pain (NRS), pain medication usage, recovery index (RI-10), return
to normal activities (RNA), return to work (RTW), direct and indirect costs
(corrected for RTW).
Background summary
Hysterectomy is one of the most frequently performed major gynaecological
surgery in women worldwide. The indication for hysterectomy can be benign or
malignant. Most (70%) of the hysterectomies are performed on benign indication.
The hysterectomy can be performed using broadly three methods; the vaginal,
laparoscopic and abdominal approach. If the vaginal approach is technically
not possible due to for example insufficient mobility of the uterus or large
uterine size, the laparoscopic route is preferred over the abdominal approach
because it is associated with less pain, less blood loss and a rapid recovery.
Presently, patients remain one night in the hospital after a total laparoscopic
hysterectomy and are usually discharged one day after surgery.
To date, a lot of surgical procedures are performed as an ambulatory procedure
in order to improve patient recovery and reduce institutional costs.
A recent systematic review shows that when a total laparoscopic hysterectomy is
performed on benign indication, when there is a supporting person at home and
patients are pre-operatively counseled, the procedure can be performed in a
same-day discharge setting. Based on the present literature no conclusions can
be drawn whether this leads to a patient satisfaction score.
Study objective
The primary objective of this study is to prove that a Total Laparoscopic
Hysterectomy performed with sameday discharge is feasible and that it leads to
equal levels of Quality of Life post-operative compared with one night
admission.
Study design
Multicentre, randomized controlled trial
Intervention
Same day discharge.
Study burden and risks
Extent of burden:
Participating women will be asked to report their recovery and quality of life
at day 1,3, 7 and 6 weeks post-operative.
Risks:
Same day discharge after total laparoscopic hysterectomy has been studies
before and seems safe in a relatively health (ASA 1-2) population. There won't
be futher risks other than associated with the surgery; perioperative
complications (bladder laesion, intestinal perforation, bleeding, infection)
and post-operative complications (bleeding, (urinetract-)infection).
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
All consenting women who undergo a total laparoscopic hysterectomy with a
benign or premalignant indication
Age 18-65 years
ASA-classification I-II
Dutch speaking
transmen undergoing transgender surgery.
Exclusion criteria
- Women who do not speak Dutch
- Women younger than 18 years
- Women with a history of a midline laparotomy
- Women without a supporting person at home
- Concomitant procedures, other than tubectomy or ovariectomy
- Indication malignant
- Deep invasive endometriosis
- Endtime of surgery past 14.00 o clock
- Patients living further than 1 hr drive from the hospital
- Contra-indications for NSAIDs
Design
Recruitment
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 | NL60294.015.17 |