Gynecologic DiseaseNCT05761275
Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach
A study testing Elective cystectomy, Elective oophorectomy and Elective salpingectomy in people with Gynecologic Disease and Adnexal Mass, run by Jean Dubuisson at 1 site in Switzerland.
Trial summary
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Gynecologic Disease, Adnexal Mass, Adnexal Cyst
- What is being tested?
- Elective cystectomy, Elective oophorectomy and Elective salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2024to 3 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged from 18 to 70 years
- Discernment capacity with oral and written consent signed
- Heterosexual intercourse (with vaginal penetration) within four weeks prior to inclusion in the study
Who cannot join
- History of rectal surgery.
- Suspected rectovaginal/retrocervical endometriosis.
- History of brachytherapy or pelvic radiation.
- Suspected malignancy.
- History of severe pelvic inflammatory disease.
- Active lower genital tract infection.
Show all 9Show fewer
- Pregnancy.
- Women who do not speak fluent French or English.
- Patients under tutelage (with or without capacity of judgement).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean Dubuisson contact
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospital
Geneva, 1205
Jean Dubuisson
About this study
Official title: Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery.
The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation/aspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.
Read the detailed description
This study focuses on women aged 18 to 70 who require surgery for benign adnexal disease (removal of an ovarian cyst, ovary and/or fallopian tube). This is a randomised study, i.e. each woman will be randomly assigned the surgical technique used for the planned operation, either vNOTES or conventional transabdominal laparoscopy.
Currently, there are no randomised clinical trials specifically investigating the impact on women's sexual quality of life after benign adnexal surgery compared to conventional transabdominal laparoscopy. Patients appear to be more reticent about the vaginal approach to surgery due to fear of possible alteration of their sexual activity afterwards. Indeed, their fears relate to the vaginal scarring that occurs during the vNOTES surgery. The vaginal scar could cause vaginal pain and pain during sexual intercourse, especially if there is a post-operative complication with the vaginal scar. The vaginal scar could also alter women's perception of their bodies during sexual intercourse. This study is necessary to answer these questions and increase women's acceptance of the vNOTES technique for benign adnexal surgery. In this way, women would benefit from the advantages of vNOTES without fearing an impact on their sexual quality of life.
The primary objective of this study is to demonstrate that the vNOTES technique, although using the vagina as an entry route, does not significantly alter the quality of sexual life of women after benign adnexal surgery compared to conventional transabdominal laparoscopy.
The secondary objectives of this study evaluate the effectiveness of vNOTES (impact on pain, length of stay after surgery and patient satisfaction), complications ( during surgery and up to 30 days after surgery), as well as the relationship between the need to cut the surgical specimen for extraction and the difficulty of microscopic analysis.
All participants in the study, regardless of the surgical technique assigned to them, will complete questionnaires to assess their quality of sexual life before surgery and at 3 and 6 months after surgery. These are the FSFI (female sexual function), CSI-16 (couple satisfaction) and a self-created questionnaire on pain during sex (dyspareunia). These questionnaires will determine whether there is a difference in the women's quality of sexual life before and after surgery, as well as comparing the two surgical techniques. The participants' general and medical data will be collected at the time of study enrolment, during hospitalisation and at one month after surgery to assess the secondary objectives of the study.
- Conditions
- Gynecologic Disease, Adnexal Mass, Adnexal Cyst, Sexuality, Adnexal Diseases, Sexual Dysfunction
- Being tested
- Elective cystectomy, Elective oophorectomy, Elective salpingectomy, Elective tubal sterilization
- Medical subject headings
- Genital Diseases, Female, Sexuality, Adnexal Diseases, Sexual Dysfunction, Physiological, Dyspareunia, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective cystectomyProcedure or surgery
Adnexal cyst removal for presumed benign adnexal pathology.
Elective oophorectomyProcedure or surgery
Ovarian removal for presumed benign adnexal pathology.
Elective salpingectomyProcedure or surgery
Tubal removal for presumed benign adnexal pathology.
Elective tubal sterilizationProcedure or surgery
Tubal obstruction as a definitive contraceptive method (tubal cauterization with or without sectioning, partial or total removal of both tubes, or obstruction with small clips/ligatures).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Abdominal Laparoscopy | Active comparator | Use of conventional transabdominal laparoscopy as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization). Receives: Procedure: Elective cystectomy; Procedure: Elective oophorectomy; Procedure: Elective salpingectomy; Procedure: Elective tubal sterilization |
| vNOTES | Experimental | Use of vNOTES (Transvaginal Natural Orifice Transluminal Endoscopic Surgery) as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization). Receives: Procedure: Elective cystectomy; Procedure: Elective oophorectomy; Procedure: Elective salpingectomy; Procedure: Elective tubal sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire.
FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Measured: Preoperative
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire.
FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Measured: 3 months postoperative
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire.
FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Measured: 6 months postoperative
Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire.
CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.
Measured: Preoperative
Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire.
CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.
Measured: 3 months postoperative
Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire.
CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.
Measured: 6 months postoperative
Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia.
This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.
Measured: Preoperative
Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia.
This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.
Measured: 3 months postoperative
Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia.
This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.
Measured: 6 months postoperative
Secondary outcomes (8)
Effectiveness
Evaluation of the success rate (removal of the specimen without the need of conversion to laparoscopy or open-surgery) and the procedure duration including the need for adhesiolysis.
Measured: Peroperative
Pain evaluation
Mean pain intensity will be evaluated with the Visual Analog Scale (VAS) which rates the pain intensity from 0 for no pain to 10 being the worst pain imaginable. Pain location will be assessed in a descriptive form.
Measured: Preoperative
Lenght of stay
Evaluation of lenght of stay in days ranging from 0 for the day of the intervention to 30 for the 30th day after the intervention.
Measured: During hospital stay, from day of the surgery up to 30 days after surgery
Pain evaluation
Pain intensity will be evaluated every day with the Visual Analog Scale (VAS) which rates the pain intensity from 0 for no pain to 10 being the worst pain imaginable. Names and classes of painkillers taken will be recorded daily during hospitalisation, noting the total milligram dosage per 24 hours for each drug (class 1 for simple analgesics, class 2 for addition of morphine derivatives, class 3 for morphine and morphine derivatives).
Measured: During hospital stay, from day of the surgery up to 30 days after surgery
Pain evaluation
Mean pain intensity will be evaluated with the Visual Analog Scale (VAS) which rates the pain intensity from 0 for no pain to 10 being the worst pain imaginable. Pain location will be assessed in a descriptive form. Assessment of analgesic intake and class of painkillers when used (class 1 for simple analgesics, class 2 for addition of morphine derivatives, class 3 for morphine and morphine derivatives).
Measured: 1 month postoperative
Complications rate
Failure to enter the peritoneal cavity, need for conversion, intraoperative complication during peritoneal cavity access, intraoperative blood loss, bowel or vessel injury.
Measured: Peroperative
Complications rate
Delayed vaginal or parietal healing (abscess, hematoma, dehiscence), trocar-site hernia, trocar-site nerve injury, re-hospitalization and re-operation.
Measured: 1 month postoperative
Histological analysis after morcellation/aspiration of the surgical specimen
Histological analysis after morcellation/aspiration of the surgical specimen : completed/ limited and diagnosis.
Measured: Peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean Dubuisson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean Dubuisson, University Hospital, Geneva
- Investigators
- Jean Dubuisson, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761275
- Sponsor's protocol ID
- 2022-00407
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krull E, Lambat Emery S, Viviano M, Aerts L, Petignat P, Dubuisson J. Assessment of women's sexual quality of life after benign adnexal surgery using vNOTES approach in comparison to conventional laparoscopy: protocol for a randomised controlled trial. BMJ Open. 2023 Sep 7;13(9):e073691. doi: 10.1136/bmjopen-2023-073691.
PubMed 37678943
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach in Comparison to Conventional Laparoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05761275
- Acronym / sponsor ID
- 2022-00407
- Conditions
- Gynecologic Disease, Adnexal Mass, Adnexal Cyst, Sexuality, Adnexal Diseases, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Jean DubuissonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery.
The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation/aspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.
Detailed description
This study focuses on women aged 18 to 70 who require surgery for benign adnexal disease (removal of an ovarian cyst, ovary and/or fallopian tube). This is a randomised study, i.e. each woman will be randomly assigned the surgical technique used for the planned operation, either vNOTES or conventional transabdominal laparoscopy.
Currently, there are no randomised clinical trials specifically investigating the impact on women's sexual quality of life after benign adnexal surgery compared to conventional transabdominal laparoscopy. Patients appear to be more reticent about the vaginal approach to surgery due to fear of possible alteration of their sexual activity afterwards. Indeed, their fears relate to the vaginal scarring that occurs during the vNOTES surgery. The vaginal scar could cause vaginal pain and pain during sexual intercourse, especially if there is a post-operative complication with the vaginal scar. The vaginal scar could also alter women's perception of their bodies during sexual intercourse. This study is necessary to answer these questions and increase women's acceptance of the vNOTES technique for benign adnexal surgery. In this way, women would benefit from the advantages of vNOTES without fearing an impact on their sexual quality of life.
The primary objective of this study is to demonstrate that the vNOTES technique, although using the vagina as an entry route, does not significantly alter the quality of sexual life of women after benign adnexal surgery compared to conventional transabdominal laparoscopy.
The secondary objectives of this study evaluate the effectiveness of vNOTES (impact on pain, length of stay after surgery and patient satisfaction), complications ( during surgery and up to 30 days after surgery), as well as the relationship between the need to cut the surgical specimen for extraction and the difficulty of microscopic analysis.
All participants in the study, regardless of the surgical technique assigned to them, will complete questionnaires to assess their quality of sexual life before surgery and at 3 and 6 months after surgery. These are the FSFI (female sexual function), CSI-16 (couple satisfaction) and a self-created questionnaire on pain during sex (dyspareunia). These questionnaires will determine whether there is a difference in the women's quality of sexual life before and after surgery, as well as comparing the two surgical techniques. The participants' general and medical data will be collected at the time of study enrolment, during hospitalisation and at one month after surgery to assess the secondary objectives of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Abdominal Laparoscopy | Active comparator | Procedure: Elective cystectomy, Procedure: Elective oophorectomy, Procedure: Elective salpingectomy, Procedure: Elective tubal sterilizationUse of conventional transabdominal laparoscopy as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization). |
| vNOTES | Experimental | Procedure: Elective cystectomy, Procedure: Elective oophorectomy, Procedure: Elective salpingectomy, Procedure: Elective tubal sterilizationUse of vNOTES (Transvaginal Natural Orifice Transluminal Endoscopic Surgery) as the surgical approach to perform the indicated procedure in the included patient with benign adnexal pathology (elective cystectomy/oophorectomy elective salpingectomy or tubal sterilization). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged from 18 to 70 years
- Discernment capacity with oral and written consent signed
- Heterosexual intercourse (with vaginal penetration) within four weeks prior to inclusion in the study
Key exclusion criteria (9 listed)
- History of rectal surgery.
- Suspected rectovaginal/retrocervical endometriosis.
- History of brachytherapy or pelvic radiation.
- Suspected malignancy.
- History of severe pelvic inflammatory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective cystectomyAdnexal cyst removal for presumed benign adnexal pathology. | Procedure or surgery | Conventional Abdominal Laparoscopy, vNOTES |
| Elective oophorectomyOvarian removal for presumed benign adnexal pathology. | Procedure or surgery | Conventional Abdominal Laparoscopy, vNOTES |
| Elective salpingectomyTubal removal for presumed benign adnexal pathology. | Procedure or surgery | Conventional Abdominal Laparoscopy, vNOTES |
| Elective tubal sterilizationTubal obstruction as a definitive contraceptive method (tubal cauterization with or without sectioning, partial or total removal of both tubes, or obstruction with small clips/ligatures). | Procedure or surgery | Conventional Abdominal Laparoscopy, vNOTES |
Primary outcome
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Time frame: Preoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Time frame: 3 months postoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Time frame: 6 months postoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
Time frame: Preoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire. CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.
Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
Time frame: 3 months postoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire. CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.
Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
Time frame: 6 months postoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire. CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.
Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
Time frame: Preoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia. This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.
Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
Time frame: 3 months postoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia. This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.
Women's quality of sexual life evaluation - Self reported questionnaire on dyspareunia
Time frame: 6 months postoperative
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using a self-reported questionnaire on dyspareunia. This questionnaire assesses presence of superficial and/or deep dyspareunia together with pain intensity. Pain intensity is assessed with the Visual Analog Scale (VAS) which rates the pain from 0 for no pain to 10 being the worst pain imaginable.
8 secondary outcomes
Effectiveness
Time frame: Peroperative
Pain evaluation
Time frame: Preoperative
Lenght of stay
Time frame: During hospital stay, from day of the surgery up to 30 days after surgery
Pain evaluation
Time frame: During hospital stay, from day of the surgery up to 30 days after surgery
Pain evaluation
Time frame: 1 month postoperative
Complications rate
Time frame: Peroperative
Complications rate
Time frame: 1 month postoperative
Histological analysis after morcellation/aspiration of the surgical specimen
Time frame: Peroperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 37678943Krull E, Lambat Emery S, Viviano M, Aerts L, Petignat P, Dubuisson J. Assessment of women's sexual quality of life after benign adnexal surgery using vNOTES approach in comparison to conventional laparoscopy: protocol for a randomised controlled trial. BMJ Open. 2023 Sep 7;13(9):e073691. doi: 10.1136/bmjopen-2023-073691.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Dubuisson contact
Jean Dubuisson principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective cystectomy, Elective oophorectomy and Elective salpingectomy in people with Gynecologic Disease and Adnexal Mass, run by Jean Dubuisson at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eloïse Krull (+41 (0)22 372 68 16, eloise.krull@bluewin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI) (time frame: Preoperative). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05761275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.