Sterilization Procedures for Women's Health
(POPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the experiences, recovery quality, and satisfaction of women after sterilization surgeries using three different methods. The treatments compared include traditional laparoscopy (surgery using small incisions and a camera), single-site laparoscopy (one incision), and V-Notes surgery (a vaginal approach). Premenopausal women planning elective sterilization without a prolapsed uterus might be suitable for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve sterilization procedures for future patients.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these sterilization procedures are safe for women's health?
Studies have shown that single-site laparoscopy reliably achieves sterilization, with a success rate of about 99% within one year. This method is generally effective and well-tolerated by most patients.
Research indicates that V-Notes surgery is also safe and suitable, particularly for non-cancerous gynecological issues. Complication rates for V-Notes are similar to or even lower than those of traditional methods, suggesting it is a well-tolerated option.
Overall, past research considers both single-site laparoscopy and V-Notes surgery safe, with low complication rates. These factors make them promising choices for those considering these procedures.12345Why are researchers excited about this trial?
Researchers are excited about the trial for sterilization procedures because it explores innovative surgical options that could enhance women's health. Unlike standard multi-port laparoscopic surgeries, single site laparoscopy involves just one small incision, which might reduce recovery time and scarring. V-Notes surgery, on the other hand, is performed through natural orifices, potentially offering even less visible scarring and a quicker return to daily activities. These approaches could offer women more choices with potentially less discomfort and faster recovery compared to traditional methods.
What evidence suggests that this trial's treatments could be effective for women's health?
This trial will compare different sterilization procedures for women's health. Research has shown that single-site laparoscopy, one of the procedures participants may undergo, is highly effective for sterilization, with one study reporting a 99% success rate within a year. This makes it a reliable option, often resulting in less blood loss and quicker recovery compared to traditional methods.
Another procedure studied in this trial is V-Notes surgery. Studies have shown positive results for this technique, linking it to less postoperative pain and a shorter hospital stay. It offers similar benefits to traditional laparoscopy but with added comfort and faster recovery. Both methods have proven effective, making them good choices for those considering sterilization procedures.24678Who Is on the Research Team?
Randa J Jalloul, MD
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
The POPS Trial is for premenopausal women who are planning to have elective sterilization surgery and can give written consent. Women with a non-prolapsed uterus are eligible, but those with conditions like rectal surgery history, suspected endometriosis or malignancy, infections, virginity or pregnancy cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo laparoscopic salpingectomy via one of three surgical routes
Immediate Recovery
Quality of recovery assessed 24 hours after surgery using the QOR-40 questionnaire
Follow-up
Participants are monitored for outcomes such as cosmesis, pain, patient satisfaction, and sexual function
What Are the Treatments Tested in This Trial?
Interventions
- Single site laparoscopy
- Traditional laparoscopy
- V-Notes surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor