NCT04331652

Bipolar 15 Charrières Office Resectoscope : Polypectomy Without Anesthesia

Bipolar 15 Charrières (Ch.) Office Resectoscope : Polypectomy Without Anesthesia - Prospective Evaluation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to the feasibility of polypectomy without anesthesia using a 15 Ch. resectoscope in women with uterine polyps.

Detailed description

Endometrial polyps are frequent gynecological pathologies leading to metrorrhagia, infertility, miscarriages and the risk of transformation into malignant pathology. The discovery of an endometrial polyp requires its removal. The treatment of endometrial polyps is conventionally carried out by hysteroscopic resection under general anesthesia with a bipolar resector of 22 Charrières (Ch) or more after dilation of the uterine cervix in the operating room. Following the recent appearance of a 15 Ch. bipolar mini-resectoscope, it seems that uterine dilation and anesthesia could be avoided by reducing the caliber of the instrument.

Conditions

• Polyps Uterus

Interventions

Type	Name	Description
PROCEDURE	Polypectomy without anesthesia or analgo-sedation	Premedication: paracetamol 1g oral. Patient will undergo polypectomy without anesthesia. During the procedure, pain will be monitored using a pain assessment scale from 0 to 10 (0 meaning no pain and 10 meaning maximum pain imaginable). At any time, if the patient express a pain strictly superior to 4 an analgo-sedation will be proposed and/or general anesthesia. Pulse and blood pressure will be monitored. Assessment of patient satisfaction after the intervention.

Timeline

• Start date: 2020-12-14
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2020-04-02
• Last updated: 2023-03-01

Locations

1 site across 1 country: France