Surgical Wound Dehiscence
Conditions
Keywords
vaginal dehiscence
Brief summary
Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication. The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.
Detailed description
A post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy. The recognition of the complication is made on a clinical basis. The investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault. The investigators will also compare the two modalities in terms of: * duration of the vaginal closure * risk of bleeding from the vaginal cuff * risk of post-operative pelvic infection * risk of re-operation * dyspareunia * total vaginal length * vaginal cuff prolapse.
Interventions
PROCEDURETRANSVAGINAL SUTURE
The closure of the vaginal cuff will be performed transvaginally using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with vaginal valves and needleholders
PROCEDURELAPAROSCOPIC SUTURE
The closure of the vaginal cuff will be performed laparoscopically using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with laparoscopic needleholders
Sponsors
Università degli Studi dell'Insubria
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy
Exclusion criteria
* Patients with gynecological malignancy (uterine and/or adnexal)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAGINAL DEHISCENCE | 3 months postoperatively | Vaginal dehiscence defined as any partial or complete separation of the vaginal vault, sutured at the end of a total laparoscopic hysterectomy. This complication is diagnosed clinically, during a gynecologic visit. Every dehiscence (whether partial or total) will be considered as an outcome event and we will measure the presence/absence of dehiscence as a percentage of the total procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAGINAL CUFF COMPLICATIONS | 3 months postoperatively | * Vaginal bleeding * Need for Vaginal re-suture * Vaginal vault prolapse * Dyspareunia * Post-operative pelvic infection |
| operative time | During Operation | Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically |
Countries
Italy
Outcome results
None listed