Hysteroscopic Intrauterine Suturing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intra-Uterine suturing by X-TACK device and hysteroscope.
- Who it may be relevant to
- Registry conditions: Niche, Uterine Disease. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study
Overview
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
- Device Intra-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
Primary outcome measures
- Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus. [Time frame: Immediately after the procedure.]
Secondary outcome measures (1)
- Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury. [Time frame: Immediately after the procedure.]
Eligibility criteria
Inclusion criteria
- Benign indication for hysterectomy
Exclusion criteria
- Evidence or suspicious for malignancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Israel · 1 center
- Emek Medical Center — Afula
Publications
- 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. PMID 34913810
- 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. Gynec PMID 28003797
- 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. PMID 23453765
Identifiers
NCT: NCT06656286 · EMC-0086-24