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Hysterectomy by Transabdominal Laparoscopy or NOTES

NCT02631837 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-04-11

Study results available
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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.

Conditions

  • Uterine Diseases

Interventions

PROCEDURE

vNOTES hysterectomy

Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy

PROCEDURE

LSC hysterectomy

Surgical removal of the uterus by transabdominal laparoscopy

Sponsors & Collaborators

  • Imelda Hospital, Bonheiden

    lead OTHER

Principal Investigators

  • Jan Baekelandt, MD · Imelda Hospital, Bonheiden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-02-24
Completion
2017-07-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631837 on ClinicalTrials.gov