Trial Outcomes & Findings for Hysterectomy by Transabdominal Laparoscopy or NOTES (NCT NCT02631837)

NCT ID: NCT02631837

Last Updated: 2023-04-11

Results Overview

Successful removal of the uterus without conversion to another technique with or without morcellation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: Intraoperative
• Results posted on: 2023-04-11

Participant Flow

Between December 9, 2015, and February 23, 2017, 194 women were screened for eligibility

Participant milestones

Measure	vNOTES Hysterectomy vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy	Total n=70 Participants Total of all reporting groups
Age, Continuous	46 Years n=35 Participants	49 Years n=35 Participants	47 Years n=70 Participants
Sex/Gender, Customized Female	35 Participants n=35 Participants	35 Participants n=35 Participants	70 Participants n=70 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	35 participants n=35 Participants	35 participants n=35 Participants	70 participants n=70 Participants
Body Mass Index	26.6 kg/m² n=35 Participants	26.4 kg/m² n=35 Participants	26.5 kg/m² n=70 Participants
Number of vaginal births	1.4 number of vaginal births n=35 Participants	1.3 number of vaginal births n=35 Participants	1.4 number of vaginal births n=70 Participants
Prior abdominal surgery	20 Participants n=35 Participants	16 Participants n=35 Participants	36 Participants n=70 Participants
Prior Caesarean section	8 Participants n=35 Participants	5 Participants n=35 Participants	13 Participants n=70 Participants
Uterine weight	206.2 grams n=35 Participants	177.3 grams n=35 Participants	191.7 grams n=70 Participants
Pain vagina sexual intercourse	15 Participants n=35 Participants	6 Participants n=35 Participants	21 Participants n=70 Participants
Pain abdomen sexual intercourse	12 Participants n=35 Participants	8 Participants n=35 Participants	20 Participants n=70 Participants
Health-related quality of life	74.6 units on a scale n=35 Participants	76.8 units on a scale n=35 Participants	75.7 units on a scale n=70 Participants

PRIMARY outcome

Timeframe: Intraoperative

Successful removal of the uterus without conversion to another technique with or without morcellation

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Successful Removal of the Uterus Without Conversion to Another Technique	35 Participants	35 Participants

SECONDARY outcome

Timeframe: Measured on the day of the surgical intervention

The number of women admitted in-hospital for at least one night observation based on their own preference after discharge from the day care unit, as a dichotomous outcome. The decision to discharge or to admit to hospital for the night will be based solely on the choice of the woman to return home the same day or stay overnight.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Admission in Hospital for at Least One Night Observation	8 Participants	20 Participants

SECONDARY outcome

Timeframe: The first seven days after the surgical intervention

Postoperative pain scores, as an ordinal outcome, measured using a Visual Analogue Scale (VAS) twice daily (morning and evening) from day 1 till 7 selfreported by the participating women. VAS scores from 0 to 10 with 0 = no pain and 10= worst pain ever imaginable.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Postoperative Pain Scores mean pain VAS score day 6 evening	1.086 units on a scale Interval 0.591 to 1.58	2.000 units on a scale Interval 1.505 to 2.495
Postoperative Pain Scores mean pain VAS score day 7 morning	1.029 units on a scale Interval 0.525 to 1.532	1.567 units on a scale Interval 1.06 to 2.074
Postoperative Pain Scores mean pain VAS score day 1 morning	3.629 units on a scale Interval 2.877 to 4.38	4.200 units on a scale Interval 3.449 to 4.951
Postoperative Pain Scores mean pain VAS score day 1 evening	3.486 units on a scale Interval 2.815 to 4.157	4.456 units on a scale Interval 3.783 to 5.129
Postoperative Pain Scores mean pain VAS score day 2 morning	2.486 units on a scale Interval 1.876 to 3.096	3.543 units on a scale Interval 2.933 to 4.153
Postoperative Pain Scores mean pain VAS score day 2 evening	2.514 units on a scale Interval 1.947 to 3.082	3.343 units on a scale Interval 2.775 to 3.91
Postoperative Pain Scores mean pain VAS score day 3 morning	1.800 units on a scale Interval 1.261 to 2.339	2.800 units on a scale Interval 2.261 to 3.339
Postoperative Pain Scores mean pain VAS score day 3 evening	1.857 units on a scale Interval 1.335 to 2.379	2.914 units on a scale Interval 2.392 to 3.436
Postoperative Pain Scores mean pain VAS score day 4 morning	1.257 units on a scale Interval 0.746 to 1.769	2.286 units on a scale Interval 1.774 to 2.797
Postoperative Pain Scores mean pain VAS score day 4 evening	1.371 units on a scale Interval 0.867 to 1.876	2.457 units on a scale Interval 1.952 to 2.962
Postoperative Pain Scores mean pain VAS score day 5 morning	1.143 units on a scale Interval 0.643 to 1.642	1.914 units on a scale Interval 1.415 to 2.414
Postoperative Pain Scores mean pain VAS score day 5 evening	1.057 units on a scale Interval 0.562 to 1.553	2.086 units on a scale Interval 1.59 to 2.581
Postoperative Pain Scores mean pain VAS score day 6 morning	0.914 units on a scale Interval 0.421 to 1.407	1.914 units on a scale Interval 1.421 to 2.407
Postoperative Pain Scores mean pain VAS score day 7 evening	0.819 units on a scale Interval 0.29 to 1.348	1.693 units on a scale Interval 1.153 to 2.233

SECONDARY outcome

Timeframe: The first week after the surgical intervention

Postoperative pain defined by the total amount of analgesics used as described in the standardized pain treatment protocol, as a continuous outcome.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
The Use of Analgetic Drugs for Postoperative Pain	8.0 number of tablets Interval 0.0 to 28.0	13.9 number of tablets Interval 0.0 to 50.0

SECONDARY outcome

Timeframe: The first six weeks after the surgical intervention

Postoperative infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or laboratory findings, detected during the first six weeks of surgery, as a dichotomous outcome.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Postoperative Infection	1 Participants	2 Participants

SECONDARY outcome

Timeframe: At the time of the surgical intervention

Intra- operative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Intra- Operative Complications	1 Participants	0 Participants

SECONDARY outcome

Timeframe: The first six weeks after the surgical intervention

Postoperative complications detected during the first six weeks of surgery, as a dichotomous outcome

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Postoperative Complications	3 Participants	13 Participants

SECONDARY outcome

Timeframe: The first six weeks after the surgical intervention

The number of women readmitted to hospital within six weeks following surgery, as a dichotomous outcome.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Hospital Readmission	1 Participants	6 Participants

SECONDARY outcome

Timeframe: Intraoperative

Duration of surgery measured as the time in minutes from the insertion of the bladder catheter to the end of vaginal/ abdominal wound closure, as a continuous outcome

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Duration of the Surgical Intervention	41.1 minutes Interval 21.0 to 130.0	75.1 minutes Interval 40.0 to 189.0

SECONDARY outcome

Timeframe: At 3 months after the surgical intervention

Incidence of vaginal dyspareunia recorded by the participants at 3 months by self-reporting using a simple questionnaire.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Vaginal Pain During Sexual Intercourse at Three Months	8 Participants	9 Participants

SECONDARY outcome

Timeframe: At 6 months after the surgical intervention

Incidence of vaginal dyspareunia recorded by the participants at 6 months by self-reporting using a simple questionnaire

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Vaginal Pain During Sexual Intercourse at Six Months	5 Participants	8 Participants

SECONDARY outcome

Timeframe: At 3 months after the surgical intervention

Incidence of pelvic dyspareunia recorded by the participants at 3 months by self-reporting using a simple questionnaire.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Pelvic Pain During Sexual Intercourse at Three Months	6 Participants	8 Participants

SECONDARY outcome

Timeframe: At 6 months after the surgical intervention

Incidence of pelvic dyspareunia recorded by the participants at 6 months by self-reporting using a simple questionnaire.

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Pelvic Pain During Sexual Intercourse at Six Months	4 Participants	5 Participants

SECONDARY outcome

Timeframe: At 3 months after the surgical intervention

Health-related quality of life at 3 months by self-reporting the EQ-5D scale.The reported values for the health-related quality of life are self-reported values using the VAS part of the two part EQ-5D-3L questionnaire. The scale ranges from 0 (worst quality) to 100 (best quality).

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Health-related Quality of Life at Three Months	83.8 score on a scale Interval 40.0 to 100.0	79.6 score on a scale Interval 20.0 to 100.0

SECONDARY outcome

Timeframe: At 6 months after the surgical intervention

Health-related quality of life at 6 months by self-reporting the EQ-5D scale. The reported values for the health-related quality of life are self-reported values using the VAS part of the two part EQ-5D-3L questionnaire. The scale ranges from 0 (worst quality) to 100 (best quality).

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Health-related Quality of Life at Six Months	87.8 score on a scale Interval 60.0 to 100.0	86.6 score on a scale Interval 65.0 to 100.0

SECONDARY outcome

Timeframe: At baseline, 3 months and 6 months after the surgical intervention

Sexual wellbeing at baseline, at 3 and 6 months by self-reporting using the SSFS (Short Sexual Function Scale). The SSFS is a questionnaire of 7 open ended questions on sexual wellbeing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 weeks postoperative

Calculating the comparative direct costs in USD of both techniques up to 6 weeks after the surgical intervention

Outcome measures

Measure	vNOTES Hysterectomy n=35 Participants vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 Participants Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Direct Costs	3452.2 USD Interval 2404.6 to 4897.1	3933.6 USD Interval 2120.6 to 6776.2

Adverse Events

vNOTES Hysterectomy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LSC Hysterectomy

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	vNOTES Hysterectomy n=35 participants at risk vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 participants at risk Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Renal and urinary disorders vesicovaginal fistula	0.00% 0/35 • 6 months Intra- or postoperative complications	2.9% 1/35 • Number of events 1 • 6 months Intra- or postoperative complications
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	0.00% 0/35 • 6 months Intra- or postoperative complications	2.9% 1/35 • Number of events 1 • 6 months Intra- or postoperative complications

Other adverse events

Measure	vNOTES Hysterectomy n=35 participants at risk vaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES hysterectomy: Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy	LSC Hysterectomy n=35 participants at risk Laparoscopic hysterectomy LSC hysterectomy: Surgical removal of the uterus by transabdominal laparoscopy
Blood and lymphatic system disorders Blood transfusion	2.9% 1/35 • Number of events 1 • 6 months Intra- or postoperative complications	5.7% 2/35 • Number of events 2 • 6 months Intra- or postoperative complications
Renal and urinary disorders Urinary tract infection	5.7% 2/35 • Number of events 2 • 6 months Intra- or postoperative complications	25.7% 9/35 • Number of events 9 • 6 months Intra- or postoperative complications

Additional Information

Dr Jan Baekelandt

Imelda ziekenhuis Bonheiden

Phone: + 32 15 505208

Email: jan.baekelandt@imelda.be

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place