Vaginal Cuff Complications
Conditions
Keywords
Laparoscopy, Hysterectomy, Vaginal cuff closure, Barbed sutures, Vaginal cuff complications, Vaginal cuff dehiscence
Brief summary
Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Among potentially life-threatening events, vaginal cuff dehiscence complicates 0.14-1.38% of procedures, and any vaginal cuff complications (dehiscence, hematoma, bleeding, infection) are estimated to affect 4.7-9.8% of patients. In this scenario, any preventive strategy can provide clinically relevant benefits. Regarding colporrhaphy, only the adoption of a laparoscopic approach instead of a vaginal approach is supported by high-quality evidence. Our group demonstrated that the laparoscopic closure of the vaginal cuff after total laparoscopic hysterectomy reduces the incidence of vaginal cuff complications. Among other potentially effective interventions, the use of barbed sutures was associated with a lower incidence of vaginal cuff dehiscence than the standard suture. In a recent meta-analysis, the use of barbed sutures has been associated with a pooled incidence of vaginal cuff dehiscence of 0.4% versus 2% after a traditional vaginal suture. However, this evidence is limited because most pooled studies were retrospective, and only two were randomized controlled trials. Moreover, these two randomized controlled trials had a very small sample size and were not powered to detect clinically relevant differences. On that basis, despite the promising utility of barbed sutures for vaginal cuff closure after total laparoscopic hysterectomy, the choice of the type of suture is not evidence-based but still guided by personal opinions, as well as by the preference and habits of the operators. Therefore, this study aims to investigate whether the laparoscopic vaginal cuff closure with barbed suture determines a lower incidence of vaginal cuff dehiscence and complications than conventional sutures after total laparoscopic hysterectomy.
Interventions
PROCEDURELaparoscopic colporrhaphy with 0-caliber barbed absorbable suture
After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)
PROCEDURELaparoscopic colporrhaphy with standard 0-caliber absorbable suture
After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ)
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The surgeon will not be blinded. Conversely, patients and co-investigators who will assess study outcomes and perform patients' follow-ups will be masked regarding the allocation arm until the study's conclusion.
Intervention model description
Multicenter, parallel arms, open-label, randomized controlled trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective total laparoscopic hysterectomy * Surgery performed for the treatment of benign pathology * Age \> 18 years * Surgery performed by laparoscopy * Signature of informed consent
Exclusion criteria
* Patients undergoing emergent surgery * Patients candidates for hysterectomy for oncological indication * Patients who underwent previous radiation therapy * Patients allergic to the suture material used in the study * Patients unable to express adequate informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal cuff dehiscence | 30 days after surgery | Any partial or total separation of the vaginal cuff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal cuff complications | 30 days after surgery | Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff |
| Hospital stay | From the date of hospital admission to the date of hospital discharge. | Days of hospitalization from the day of admission to the day of discharge. |
| Operative time | During surgery | Time between first incision and skin closure |
| Intraoperative blood loss | During surgery | Total blood aspirate during the surgical procedure |
| 30-day post-surgical morbidity | 30 days after surgery | Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification |
| Quality of life index | 90 days after surgery | The Short Form 12 Health Survey (SF-12) investigates 8 different health aspects. Physical activity, role and physical health, role and emotional state, and mental health are measured by two questions. The SF-12 scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. |
| Sexual function | 90 days after surgery | The female sexual function index (FSFI) consists of 19 multiple-choice items that assess female sexual functioning based on 6 domains: desire, arousal, orgasm, pain, sexual satisfaction, and lubrication. The total score ranges from 0 to 36, with 26.55 as the cut-off suggesting the presence of sexual dysfunction. The higher the score, the better the sexual function. |
Countries
Italy
Contacts
CONTACTStefano Uccella, MD, PhD
CONTACTSimone Garzon, MD
PRINCIPAL_INVESTIGATORStefano Uccella, MD, PhD
Universita di Verona
PRINCIPAL_INVESTIGATORSimone Garzon, MD
Universita di Verona
PRINCIPAL_INVESTIGATORPier Carlo Zorzato, MD
Universita di Verona
Outcome results
None listed