Clinical trial · Observational
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Uterine Bleeding | — | UNRESOLVED | — |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometriosis | — | UNRESOLVED | — |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
| Uterine Prolapse | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Closure of the Vaginal Cuff after Total Hysterectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SYMMCORA®
- description
- Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
- interventionNames
- Device: Closure of the Vaginal Cuff after Total Hysterectomy
- label
- V-Loc®
- description
- Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
- interventionNames
- Device: Closure of the Vaginal Cuff after Total Hysterectomy
Primary outcomes (1)
- measure
- Suturing time to close the vaginal cuff
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females undergoing an elective, laparoscopic total hysterectomy * Age ≥ 18 years * Written informed consent Exclusion Criteria: * Emergency surgery * Open surgery * Patients undergone immunosuppressive drug treatment within the prior 6 months * Patients with hypersensitivity or allergy to the suture material. * Participation in another clinical study * Non-compliance of patient
References
Publications (1)
- DERIVEDBaumann P, Sanchez LH, Garcia NG, Sologiuc L, Hornemann A. Assessment of a novel unidirectional mid-term absorbable barbed suture versus a competitor barbed suture for vaginal cuff closure after gynaecology surgery, study protocol of a randomized controlled trial - BARHYSTER. BMC Surg. 2025 Jan 14;25(1):23. doi: 10.1186/s12893-024-02700-z. PMID 39806425