Sterility, FemalePOPSNCT05518175
Patient-centered Outcomes After Permanent Female Sterilization Procedure(POPS Trial)
A study testing Traditional laparoscopy, Single site laparoscopy and V-Notes surgery in people with Sterility, Female, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Sterility, Female
- What is being tested?
- Traditional laparoscopy, Single site laparoscopy and V-Notes surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity
- non-prolapsed uterus
- Patients should able to provide written consent
Who cannot join
- Women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy
- Postpartum (immediate) tubal sterilization
- Tubal sterilization during a cesarean section
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Patient-centered Outcomes After Permanent Female Sterilization Procedure: A Randomized Controlled Trial Comparing Three Surgical Routes
The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.
- Conditions
- Sterility, Female
- Being tested
- Traditional laparoscopy, Single site laparoscopy, V-Notes surgery
- Keywords
- laparoscopy, quality of recovery, vaginal natural orifice transluminal endoscopic surgery
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional laparoscopyProcedure or surgery
Utilizes three or four ports for access and retrieval.
Single site laparoscopyProcedure or surgery
One port is placed via a 2 to 3 cm umbilical/fascia incision. With this technique, there is a single incision, hidden in the umbilicus.
V-Notes surgeryProcedure or surgery
One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars.
| Study group | Role | What they receive |
|---|---|---|
| Route A: Traditional laparoscopy | Active comparator | Not described Receives: Procedure: Traditional laparoscopy |
| Route B: Single site laparoscopy | Experimental | Not described Receives: Procedure: Single site laparoscopy |
| Route C:V-Notes surgery | Experimental | Not described Receives: Procedure: V-Notes surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome
Measured: 24 hours after surgery
Secondary outcomes (10)
Cosmesis as assessed by the Body Image Questionnaire
This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image
Measured: 2 weeks post surgery
Cosmesis as assessed by the Body Image Questionnaire
This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image
Measured: 6 weeks post surgery
Cosmesis as assessed by the Body Image Questionnaire
This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image
Measured: 3 months post surgery
Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)
This has 9 items that address sexual dysfunctions. Each of these items are scored on a six-point scale ranging from 0 to 5, higher the score the better sexual function.
Measured: Baseline, 3 months post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
Measured: 24 hours post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
Measured: 2 weeks post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
Measured: 6 weeks post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
Measured: 3 months post surgery
Pain as assessed by the Dynamic Visual Analog Scale (VAS)
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain after a voluntary cough (dynamic VAS)
Measured: 3 months post surgery
Patient satisfaction as assessed by the satisfaction scale
Patients will rate their satisfaction on a 5 point Likert scale from 1(very unsatisfied) to 5(very satisfied)
Measured: 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start15 Nov 2022
- Primary completion7 Mar 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sterility, FemaleStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Jalloul, The University of Texas Health Science Center, Houston
- Investigators
- Randa J Jalloul, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518175
- Sponsor's protocol ID
- HSC-MS-22-0470
- Acronym
- POPS
- Status last verified
- Jun 2025
- First submitted
- 24 Aug 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Outcomes After Permanent Female Sterilization Procedure: A Randomized Controlled Trial Comparing Three Surgical Routes
- ClinicalTrials.gov ID
- NCT05518175
- Acronym / sponsor ID
- POPS / HSC-MS-22-0470
- Conditions
- Sterility, Female
- Keywords
- laparoscopy, quality of recovery, vaginal natural orifice transluminal endoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 26 Aug 2022 (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.
The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Route A: Traditional laparoscopy | Active comparator | Procedure: Traditional laparoscopy |
| Route B: Single site laparoscopy | Experimental | Procedure: Single site laparoscopy |
| Route C:V-Notes surgery | Experimental | Procedure: V-Notes surgery |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity
- non-prolapsed uterus
- Patients should able to provide written consent
Key exclusion criteria (3 listed)
- Women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy
- Postpartum (immediate) tubal sterilization
- Tubal sterilization during a cesarean section
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 |
|---|---|---|
| Traditional laparoscopyUtilizes three or four ports for access and retrieval. | Procedure or surgery | Route A: Traditional laparoscopy |
| Single site laparoscopyOne port is placed via a 2 to 3 cm umbilical/fascia incision. With this technique, there is a single incision, hidden in the umbilicus. | Procedure or surgery | Route B: Single site laparoscopy |
| V-Notes surgeryOne port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars. | Procedure or surgery | Route C:V-Notes surgery |
Primary outcome
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
Time frame: 24 hours after surgery
This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome
10 secondary outcomes
Cosmesis as assessed by the Body Image Questionnaire
Time frame: 2 weeks post surgery
Cosmesis as assessed by the Body Image Questionnaire
Time frame: 6 weeks post surgery
Cosmesis as assessed by the Body Image Questionnaire
Time frame: 3 months post surgery
Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)
Time frame: Baseline, 3 months post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time frame: 24 hours post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time frame: 2 weeks post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time frame: 6 weeks post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time frame: 3 months post surgery
Pain as assessed by the Dynamic Visual Analog Scale (VAS)
Time frame: 3 months post surgery
Patient satisfaction as assessed by the satisfaction scale
Time frame: 3 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- 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. This study is not recruiting at the moment.
Randa J Jalloul, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional laparoscopy, Single site laparoscopy and V-Notes surgery in people with Sterility, Female, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 26 Jan 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.