Clinical trial NCT06656286: Hysteroscopic Intrauterine Suturing
Official title: Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Niche
Uterine Disease
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

* Benign indication for hysterectomy

Exclusion Criteria:

* Evidence or suspicious for malignancy

Primary outcomes:
measure: Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus.
timeFrame: Immediately after the procedure.
Secondary outcomes:
measure: Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury.
timeFrame: Immediately after the procedure.
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
References:
citation: Vila Famada A, Cos Plans R, Costa Canals L, Rojas Torrijos M, Rodriguez Vicente A, Bainac Albadalejo A. Outcomes of surgical hysteroscopy: 25 years of observational study. J Obstet Gynaecol. 2022 Jul;42(5):1365-1369. doi: 10.1080/01443615.2021.1971176. Epub 2021 Dec 16.
citation: Umranikar S, Clark TJ, Saridogan E, Miligkos D, Arambage K, Torbe E, Campo R, Di Spiezio Sardo A, Tanos V, Grimbizis G; British Society for Gynaecological Endoscopy /European Society for Gynaecological Endoscopy Guideline Development Group for Management of Fluid Distension Media in Operative Hysteroscopy. BSGE/ESGE guideline on management of fluid distension media in operative hysteroscopy. Gynecol Surg. 2016;13(4):289-303. doi: 10.1007/s10397-016-0983-z. Epub 2016 Oct 6. No abstract available.
citation: Bahar R, Shimonovitz M, Benshushan A, Shushan A. Case-control study of complications associated with bipolar and monopolar hysteroscopic operations. J Minim Invasive Gynecol. 2013 May-Jun;20(3):376-80. doi: 10.1016/j.jmig.2012.12.012. Epub 2013 Feb 27.