Laparoscopic Surgery Clinical Trial
— NOTABLEOfficial title:
Adnexectomy for Benign Gynaecological Pathology by Natural Orifice Transluminal Endoscopy or Laparoscopy
Verified date | June 2020 |
Source | Imelda Hospital, Bonheiden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and
established laparoscopic removal of benign adnexal masses Study design: Randomized
controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial.
Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal
masses detected by clinical examination and ultrasound.
Randomization: Women will be randomly allocated to undergo one of two techniques for removal
of the benign adnexal mass immediately before surgery by using a computer generated
randomization list. The investigators will use stratified randomization according to the cyst
diameter.
Intervention: Women will be treated by a surgeon who is not blinded to the treatment
allocation and who is equally skilled in performing both techniques. In the intervention
group a vNOTES technique will be used.
Control: In the control group surgery will be done by a classical laparoscopic technique.
Participants, nursing staff and outcome assessors will be blinded.
Main study parameters/endpoints:
Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary
outcomes: the proportion of women discharged the same day based on their own preference;
postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7
by the participating women following surgery and the total amount of analgesics used as
described in the standardized pain treatment protocol between day 1 till 7; postoperative
infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or
laboratory findings; per- or postoperative complications according to the Clavien- Dindo
classification detected during the first six weeks of surgery; duration of the surgical
procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6
months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing
recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale);
direct costs associated up to 6 weeks after the surgical intervention with both procedures.
Status | Completed |
Enrollment | 66 |
Est. completion date | April 16, 2020 |
Est. primary completion date | April 16, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - All women aged 18 to 70 years regardless of parity with a symptomatic adnexal mass presumed to be benign based on ultrasound examination by applying the IOTA simple rules - All women aged 18 to 70 years regardless of parity with an asymptomatic persistent adnexal mass presumed to be benign based on ultrasound examination by applying the IOTA simple rules - Written informed consent obtained prior to surgery Exclusion Criteria: - History of hysterectomy by any technique - History of rectal surgery - Suspected rectovaginal endometriosis - Suspected endometriotic cyst - Solid adnexal mass - High suspicion of adnexal malignancy based on clinical, ultrasound or biochemical findings - 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 - Need for other uterine surgical intervention (i.e. endometrial ablation, resection, myomectomy or hysterectomy) - Additional pathology necessitating hysterectomy - Failure to provide written informed consent prior to surgery |
Country | Name | City | State |
---|---|---|---|
Belgium | Imelda Hospital | Bonheiden | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Imelda Hospital, Bonheiden |
Belgium,
Baekelandt J. Poor man's NOTES: can it be a good approach for adhesiolysis? A first case report with video demonstration. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):319. doi: 10.1016/j.jmig.2014.11.001. Epub 2014 Nov 10. — View Citation
Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May — View Citation
Medeiros LR, Rosa DD, Bozzetti MC, Fachel JM, Furness S, Garry R, Rosa MI, Stein AT. Laparoscopy versus laparotomy for benign ovarian tumour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004751. doi: 10.1002/14651858.CD004751.pub3. Review. — View Citation
Wang PH, Lee WL, Juang CM, Tsai WY, Chao HT, Yuan CC. Excision of mature teratoma using culdotomy, with and without laparoscopy: a prospective randomised trial. BJOG. 2001 Jan;108(1):91-4. — View Citation
Yang YS, Hur MH, Oh KY, Kim SY. Transvaginal natural orifice transluminal endoscopic surgery for adnexal masses. J Obstet Gynaecol Res. 2013 Dec;39(12):1604-9. doi: 10.1111/jog.12108. Epub 2013 Jul 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful removal of adnexal mass without spill | The proportion of women successfully treated by removing the adnexal mass without spill, using a dichotomous outcome measure, will be used as a measure of efficacy. | Intraoperative | |
Secondary | Discharge from the hospital the day of the surgical intervention | The proportion of women discharged the same day based on their own preference, 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. | Dichotomous outcome measured on the day of the surgical intervention | |
Secondary | Postoperative pain scores | Postoperative pain scores, as an ordinal outcome, measured using a VAS scale twice daily from day 1 till 7 self-reported by the participating women | The first week after the surgical intervention | |
Secondary | The use of analgesics for postoperative pain | Postoperative pain defined by the total amount of analgesics used as described in the standardized pain treatment protocol, as a continuous outcome. | The first week after the surgical intervention | |
Secondary | Postoperative infection | 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. | The first six weeks after the surgical intervention | |
Secondary | Complications | Per- or postoperative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome | The first six weeks after the surgical intervention | |
Secondary | Hospital readmission | The proportion of women readmitted to hospital within six weeks of surgery, as a dichotomous outcome | The first six weeks after the surgical intervention | |
Secondary | Pain during sexual intercourse | Incidence and intensity of dyspareunia recorded by the participants at 3 and 6 months by self-reporting using a simple questionnaire and VAS scale, as a dichotomous and ordinal outcome | At baseline, 3 months and 6 months after the surgical intervention | |
Secondary | Sexual well being | Sexual wellbeing at baseline, at 3 and 6 months by self-reporting using the SSFS (Short Sexual Function Scale). | At baseline, 3 months and 6 months after the surgical intervention | |
Secondary | Duration of the surgical intervention | 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 | Intraoperative | |
Secondary | Direct and indirect costs | Calculating the comparative direct costs of both techniques up to 6 weeks after the surgical intervention | Up to 6 weeks postoperative | |
Secondary | Health-related quality of life | Health-related quality of life, at baseline, at 3 and 6 months by self-reporting the EQ-5D-3L questionnaire | At baseline, at 3 months and 6 months after the surgical intervention |
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