NCT06024109

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2024Jan 2027

First Submitted

Initial submission to the registry

August 15, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

August 15, 2023

Last Update Submit

May 12, 2025

Conditions

Abnormal Uterine BleedingEndometriosisUterine ProlapseUterine CancerOvarian CancerFallopian Tube CancerCervical CancerEndometrial Cancer

Keywords

Barbed SutureHysterectomyLaparoscopyMinimal Invasive

Outcome Measures

Primary Outcomes (1)

  • Suturing time to close the vaginal cuff

    Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).

    intraoperatively

Secondary Outcomes (16)

  • Number of patients with early complications

    at discharge (up to 10 days after surgery)

  • Number of patients with complications over the study period

    at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively

  • Number of patients with device deficiencies over the study period

    intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively

  • Patient satisfaction (VAS 0-100) over time

    at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively

  • Progress of Female Sexual Function Index (FSFI) compared to baseline

    Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively

  • +11 more secondary outcomes

Study Arms (2)

SYMMCORA®

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).

Device: Closure of the Vaginal Cuff after Total Hysterectomy

V-Loc®

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).

Device: Closure of the Vaginal Cuff after Total Hysterectomy

Interventions

Closure of the Vaginal Cuff after Total HysterectomyDEVICE

Closure of the vaginal cuff in patients undergoing laparoscopic total 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).

Also known as: Suturing
SYMMCORA®V-Loc®

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients undergoing an elective, laparoscopic total hysterectomy

You may qualify if:

  • Females undergoing an elective, laparoscopic total hysterectomy
  • Age ≥ 18 years
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinikum Sachsenhausen der DGD

Frankfurt am Main, Hesse, 60594, Germany

RECRUITING

Hospital Sant Joan de Déu de Manresa

Manresa, Barcelona, 08243, Spain

RECRUITING

Related Publications (1)

  • Baumann 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: 39806425DERIVED

MeSH Terms

Conditions

MetrorrhagiaEndometriosisUterine ProlapseUterine NeoplasmsOvarian NeoplasmsFallopian Tube NeoplasmsUterine Cervical NeoplasmsEndometrial Neoplasms

Interventions

Sutures

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesUterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Amadeus Hornemann, Prof. Dr.

    Klinikum Sachsenhausen der DGD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Baumann

CONTACT

+49746195petra.baumann@aesculap.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

September 6, 2023

Study Start

March 19, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)DE(1)