Niche, Uterine Disease
Conditions
Brief summary
Clinical trial The aim of the study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack, inserted into the uterus by hysteroscope. Primary outcome: Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed. Secondary outcome: Procedure complications. Study Design Interventional pilot Study Study group: Women undergoing laparoscopic hysterectomy.
Detailed description
Introduction: A hysteroscopy is a procedure used to examine and treat the inside of the uterus. Apollo X-tack is an endoscopic apparatus for stomach defect closure by gastroscopy. The aim of this study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack inserted into the uterus by hysteroscope. Study Design Interventional pilot study Study group: Women undergoing laparoscopic hysterectomy. Inclusion criteria: Benign indication for hysterectomy Exclusion from the study: Evidence or suspicious for malignancy Sample size calculation: Pilot study of 2 patients. Primary outcome: Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed. Secondary outcome: Procedure complications. Recruitment: The recruitment of the patients will be done at the gynecology department before the surgery. Procedure: After general anesthesia and entering the abdomen with the laparoscope, Truclear hysteroscope with X-tack attached will be inserted to the uterine cavity. Insertion of normal saline to the cavity and applying 4 points suturing to the uterus. The procedure will be monitored by external laparoscopic camera located in the abdominal cavity. After the hysterectomy the uterus will be opened and the suture will be examine. A preoperative intrauterine incision using a hysteroscope, followed by suturing, will be considered based on the success of the first procedure. CRF: Demographics information, obstetrics and gynecology information, surgery type, surgery indication. Procedure duration, success, amount of fluid used, cervical dilatation, complications.
Interventions
DEVICEIntra-Uterine suturing by X-TACK device and hysteroscope
After general anesthesia and entering the abdomen with the laparoscope, Truclear hysteroscope with X-tack attached will be inserted to the uterine cavity. Insertion of normal saline to the cavity and applying 4 points suturing to the uterus. The procedure will be monitored by external laparoscopic camera located in the abdominal cavity. After the hysterectomy the uterus will be opened and the suture will be examine. A preoperative intrauterine incision using a hysteroscope, followed by suturing, will be considered based on the success of the first procedure.
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Benign indication for hysterectomy
Exclusion criteria
* Evidence or suspicious for malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus. | Immediately after the procedure. | When the uterus will be opened the suture will be observed. |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury. | Immediately after the procedure. |
Countries
Israel
Outcome results
None listed