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.
Females undergoing an elective, laparoscopic total hysterectomy
Age ≥ 18 years
Written informed consent
Emergency surgery
Open surgery
Patients undergone immunosuppressive drug treatment within the prior 6 months
Patients with hypersensitivity or allergy to the suture material.
Female patients undergoing an elective, laparoscopic total hysterectomy
Case-control
Prospective
Closure of the Vaginal Cuff after Total Hysterectomy
DeviceClosure 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).
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).
Number of patients with early complications
Documented early complications include Hemoglobin drop and Fever more than 38°C within 48 hours
Number of patients with complications over the study period
Documented complications include Vaginal cuff infection, Vaginal cuff dehiscence (Defined as a visually confirmed partial or complete opening of the vaginal stump with or without visceral organ herniation), Vaginal cuff granulation formation, Pelvic Abscess Formation, Hematoma, Vaginal spotting (defined as bloody vaginal discharge that did not require extraordinary procedures or medication and disappeared spontaneously. (Days of postoperative bleeding, Number of pads / tampons used), Vaginal bleeding (Defined as postoperative vaginal stump bleeding that required additional stump suture to stop bleeding. (Days of postoperative bleeding, number of pads / tampons used), Urinary tract infection, Bladder injury, Ureter injury, Bowel obstruction, Ileus, Cystitis and Pelvic Adhesions.
Number of patients with device deficiencies over the study period
Documented device deficiencies include Suture rupture, Knots in the thread, Connection between needle and thread not intact and Disconnection of the anchor from the thread
Patient satisfaction (VAS 0-100) over time
The patient's self assessment of her satisfaction with the surgery. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "low" and "100" at the opposite end representing "high". The value is measured in \[mm\] with a ruler and documented in whole numbers.
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Aesculap AG
Lead sponsor
B.Braun Surgical SA
Collaborator
