N/A
N=70
Hysterectomy by Transabdominal Laparoscopy or NOTES
Uterine Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02631837 ↗Enrolled (actual)
70
Serious AEs
2.9%
Results posted
Jun 2020
Primary outcome: Primary: Successful Removal of the Uterus Without Conversion to Another Technique — 35; 35 Participants — p=0.0221
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- vNOTES hysterectomy (Procedure); LSC hysterectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imelda Hospital, Bonheiden
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Removal of the Uterus Without Conversion to Another Technique |
35; 35 | 0.0221 sig |
| SECONDARY Admission in Hospital for at Least One Night Observation |
8; 20 | 0.007 sig |
| SECONDARY Postoperative Pain Scores |
3.629; 4.200; 3.486; 4.456; 2.486; 3.543 | — |
| SECONDARY The Use of Analgetic Drugs for Postoperative Pain |
8.0; 13.9 | 0.006 sig |
| SECONDARY Postoperative Infection |
1; 2 | 1.00 |
| SECONDARY Intra- Operative Complications |
1; 0 | > 0.05 |
| SECONDARY Postoperative Complications |
3; 13 | 0.009 sig |
| SECONDARY Hospital Readmission |
1; 6 | 0.106 |
| SECONDARY Duration of the Surgical Intervention |
41.1; 75.1 | < 0.01 sig |
| SECONDARY Vaginal Pain During Sexual Intercourse at Three Months |
8; 9 | 0.7604 |
| SECONDARY Vaginal Pain During Sexual Intercourse at Six Months |
5; 8 | 0.3071 |
| SECONDARY Pelvic Pain During Sexual Intercourse at Three Months |
6; 8 | 0.4541 |
| SECONDARY Pelvic Pain During Sexual Intercourse at Six Months |
4; 5 | 0.4514 |
| SECONDARY Health-related Quality of Life at Three Months |
83.8; 79.6 | 0.3473 |
| SECONDARY Health-related Quality of Life at Six Months |
87.8; 86.6 | 0.3473 |
| SECONDARY Sexual Well Being |
— | — |
| SECONDARY Direct Costs |
3452.2; 3933.6 | 0.110 |
Summary
Objective: To randomly compare hysterectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy uterus in women with benign gynecological pathology.
Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.
Study population: All women aged 18 to 70 years regardless of parity with a non-prolapsed uterus and a benign indication for hysterectomy.
Primary study outcome parameters: successful removal of the uterus by the intended technique.
Secondary outcomes: the proportion of women admitted to the in-hospital ward; postoperative pain scores; the total amount of analgesics used; postoperative infection; per- or postoperative complications; hospital readmission rates; duration of the surgical procedure; incidence and intensity of dyspareunia; sexual wellbeing; health-related quality of life; costs.
Eligibility Criteria
Inclusion Criteria
- All women aged 18 to 70 years regardless of parity, with a non-prolapsed uterus in need of a hysterectomy for benign indication
- Written informed consent obtained prior to surgery
Exclusion Criteria
- History of rectal surgery
- Suspected rectovaginal endometriosis
- Suspected malignancy
- History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess
- Active lower genital tract infection e.g. Chlamydia, N. gonorrhoeae
- Virgo
- Pregnancy
- Failure to provide written informed consent prior to surgery
Data sourced from ClinicalTrials.gov (NCT02631837). 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.