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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Sponsor: Nantes University Hospital
Summary
HYPHOP is a multicenter, randomized clinical trial comparing two care pathways for women who need operative hysteroscopy to treat intrauterine lesions, such as uterine polyps, small submucosal fibroids, or retained pregnancy tissue. Participants will be randomly assigned to one of two groups. The first group will undergo hysteroscopic morcellation/aspiration in an outpatient consultation room, without requiring an operating room. The second group will undergo hysteroscopy using a resectoscope in the operating room, usually under general or regional anesthesia. The main objective is to determine whether outpatient hysteroscopic morcellation/aspiration provides better value for money than conventional operating-room hysteroscopy, by comparing costs and health-related quality of life over six months from inclusion. The study will also compare symptoms, quality of life, pain, complications, the need for further treatment, patient and practitioner satisfaction, and healthcare resource use. The hypothesis is that the outpatient care pathway may reduce costs without compromising patient outcomes.
Official title: Cost-utility Analysis of Office Hysteroscopic Morcellation/Aspiration Versus Conventional Operating-room Resectoscopy for Intrauterine Pathologies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
474
Start Date
2026-11
Completion Date
2030-03
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Operating-room hysteroscopy with resectoscope
A resectoscope is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the examination of the uterus and the treatment of gynecological conditions through the natural passages (vagina, cervix). It provides direct access to the interior of the uterine cavity without the need for an abdominal incision. The procedure is performed in the operating room under general or regional anesthesia. The resectoscope is used for myomectomy, polypectomy, resection of retained trophoblasts or placental remnants, or division of a septum The procedure is performed as follows: 1. Positioning of the patient and anesthesia 2. Insertion of the resectoscope and exploration 3. Surgical phase 4. Removal of the resectoscope and monitoring The procedure is contraindicated in cases of active genital infection
Outpatient hysteroscopic morcellation/aspiration
The therapeutic hysteroscope with fragmentation and aspiration is a surgical instrument used to perform surgical procedures within the uterine cavity. It allows for the rapid and precise removal of abnormal tissue without the need for incisions. The procedure is performed in a dedicated examination room (clean room). It can be used outside the operating room with or without local anesthesia. Morcellation/aspiration hysteroscopy is indicated for myomectomy, polypectomy, and resection of retained trophoblasts or placental remnants. The procedure is performed as follows: 1. Positioning of the patient, with or without multimodal anesthesia 2. Insertion of the therapeutic fragmentation-aspiration hysteroscope and exploration 3. Surgical phase 4. Removal of the therapeutic fragmentation-aspiration hysteroscope and monitoring The procedure is contraindicated in cases of active genital infection
Locations (9)
Hopital ESTAING
Clermont-Ferrand, France
Hôpital intercommunal de Créteil
Créteil, France
GHEM Simone VEIL Site Eaubonne
Eaubonne, France
Ch Marmande Chic
Marmande, France
APHM Hopital Nord
Marseille, France
CHU Saint Louis site Lariboisière - APHP-
Paris, France
Chu Pitie Salpetriere
Paris, France
CHU Robert Debré APHP
Paris, France
CHI Poissy
Poissy, France