Laparoscopic cuff closure after laparoscopic hysterectomy is associated with a nearly 3-fold reduction in vaginal dehiscence as compared to vaginal cuff closure reports the result of first randomized control trial published in May issue of American Journal of Obstetrics and Gynecology.
Total Laparoscopic Hysterectomy (TLH) is rapidly gaining popularity among surgeons and patients as the desired route for performing hysterectomies. It results in better cosmetic outcomes and quick return to normal activities as compared to open surgery.
However, it is also associated with higher incidence of vaginal cuff dehiscence (5–10 times higher) compared with the abdominal and/or vaginal hysterectomy. It may be because of thermal damage, difficult laparoscopic suturing techniques, reduced suture width because of magnification, or early resumption of intimacy and daily activities.
An earlier meta-analysis of case series and case-control studies suggested that a transvaginal approach of vault closure after TLH reduces the incidence of vaginal cuff dehiscence. But, these studies have drawbacks of retrospective data collection and lack of standardized protocol for post-operative data collection.
This is the first multicenter RCT carried out at 8 Italian institutions over a period of 2.25 years (NCT02453165). All women above 18 years of age, with benign condition scheduled for elective TLH up to colotomy stage, were included in the study.
A total of 1395 women were randomized in 1:1 to receive either transvaginal(TV) cuff closure (695 women) or laparoscopic (LPS) closure (700 women). The vaginal cuff closure in both the arms was done by the single-layer technique with braided and coated 0-polyglactin suture on a half-circle HR26 needle. In LPS arm intracorporeal knot-tying technique was used.
All women were advised to avoid intercourse for 2 months and they were followed up 3 months postoperatively because almost all vaginal cuff dehiscences after TLH occur within 2 months after surgery.
The researchers looked at the rate of vaginal cuff dehiscence as the primary outcome while vaginal bleeding, vaginal cuff hematoma, postoperative infection, vaginal resuturing, and any reoperation were secondary outcome studied.
Patients in the TV arm had a significantly higher incidence of vaginal dehiscence and any vaginal complications, cuff hematoma, vaginal bleeding, post-operative infection and vaginal resuturing (P<.05).
Women who were premenopausal or smoked were at higher risk of vaginal dehiscence independent of the route of closure.
The findings were so striking that the data monitoring committee ordered the trial to be terminated early.
The study was endorsed by Italian Society of Gynecologic Endoscopy which ensured that the surgical procedures were efficiently performed. Randomized design, large sample size and good follow-up program ensured the reliability and robustness of the study data.
The study has some limitations in terms of using only one type of suture, and not taking into account the role of barbed sutures. Finally, in accordance with other surgical trials, unavoidable human surgical skill variations may play a role in the results.
The authors concluded, “LPS closure of the vaginal cuff at the end of TLH has been proven to be associated with less vaginal dehiscence, vaginal cuff hematomas, vaginal bleeding, vaginal resuture, and postoperative infections, compared to the TV suturing route. This study may change practice due to its impact and represents an important step toward an evidence-based approach to TLH, and more so in general, toward a standardization of gynecological surgical procedures.”
