Leiomyoma, Uterine study: Deep Neuromuscular Blockade vs Standard
Official title Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
ClinicalTrials.gov ID: NCT07730970
What this study is testing
What is Deep Neuromuscular Blockade (NMB)?
Deep Neuromuscular Blockade (NMB) is an investigational medicine, given as a once-daily IV infusion (through a vein), being studied as a potential treatment for leiomyoma, uterine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a short low‑residue diet before surgery, deeper muscle relaxation during surgery, or both together make the surgical view clearer, allowing lower pressure during the procedure.
- Who it's for
- Women scheduled for a vaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy for benign uterine conditions.
- What's involved
- Participants will be randomly assigned to one of four groups: diet or no diet, and standard or deep muscle relaxation. They will follow a low‑residue diet for three days if assigned, receive the assigned level of muscle relaxation during surgery, and have video recordings of the surgical view evaluated by blinded reviewers.
- Time commitment
- The study involves the pre‑surgery diet period, the surgery itself, and a short follow‑up; no extra clinic visits beyond the standard surgical care are required.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Adult women (aged 18 years or older) scheduled for hysterectomy for a benign (non-cancer) indication.
- Judged suitable for the vNOTES approach by the operating surgeon.
- Able to understand the study and provide written informed consent.
You likely can't join if
- Suspected or known gynaecological malignancy.
- Conditions expected to make the approach or the field assessment non-standard (e.g., anticipated dense pelvic adhesions or severe endometriosis, a...
- Any medical reason why deep neuromuscular blockade or sugammadex would be unsafe (defined with the anaesthesia team).
- Any medical reason why a low-residue diet would be unsuitable.
- Inability to give informed consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Istanbul, KARTAL, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Istanbul, KARTAL, Turkey (Türkiye). Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.