Benign indication for hysterectomy
Conditions
Interventions
Vaginal NOTES hysterectomy (VANH) versus vaginal hysterectomy
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: - Written and orally given informed consent - 18 years and older - Native Dutch speaker or in control of the Dutch language in speaking and writing - Indication for hysterectomy for benign indication - Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination
Exclusion criteria
Exclusion criteria: - Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist - History of more than 1 caesarean section - History of endometriosis - History of rectal surgery - History of pelvic radiation - Suspected rectovaginal endometriosis - History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis) - Virginity - Pregnancy - Indication for anterior or posterior colporrhaphy during the same surgery - Indication of mid urethral slings - Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is the difference in percentage of SDD in both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Complications, severity scored by Clavien-Dindo classification (see attachment 6) o Injuries to bowel, bladder, ureter, vessels, nerves o Thrombo-embolic events o Haematoma requiring surgical intervention o Haemorrhage requiring transfusion or surgical intervention o Wound dehiscence requiring surgical intervention o Wound infections including vaginal vault abscesses • Treatment related outcomes o Conversion rate o Time in operation room (measured from entering the operating theatre until leaving the theatre to the recovery) o Surgery time (start of incision and end of surgical procedure) o Blood loss (measured in mL) o Pain measured in numeric rating scale (NRS) at: 1 hours postoperative, 8 hours postoperative and 24 hours postoperative o Recovery of pain (measured in NRS) within the first week after surgery o Use of analgesics (daily use of paracetamol, NSAIDs, opioids) o Resumption of daily activity o Hospital readmission within 6 weeks after surgery o Post-operative pain the first 7 days after surgery (measured on a numeric rating scale (NRS)) • Intended number of salpingectomies in each group • Number of salpingectomies performed in each group • Recovery index-10 (RI-10) measured on different moments pre- and post-operative • Health-related quality of life (EQ-5D-5L questionnaire) • Costs (including intervention costs, hospital costs, healthcare costs outside the hospital and costs due to loss of productivity; using an adapted version of iMCQ questionnaire) . • Cost-effectiveness (of VANH versus VH) | — |
Contacts
Public ContactIlse Bekkers
Zuyderland Medical Centre
Outcome results
None listed