Clinical trial NCT05174988: Reducing Postoperative Bleeding After Hysterectomy Via Independent Closure of Vaginal Cuff Angles
Official title: Reducing Postoperative Bleeding After Hysterectomy Via Independent Closure of Vaginal Cuff Angles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Bleeding
Patient Satisfaction
Complications
Operative Time
Keywords: bleeding
hysterectomy
cuff
closure
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose prospectively evaluating if adding separate sutures to the angles of the vaginal cuff before running barbed suture reduces the incidence of patient's perception of bleeding after surgery.

Detailed description: Hysterectomy is the most common surgical procedure in the United States, with over 600,000 performed annually.1 There has been a dramatic improvement in expected postoperative course secondary to the advancement of minimally invasive gynecologic surgery.2 With the advent of laparoscopy and robotic surgery, even the most complex cases can be successfully performed via a minimally invasive approach. What used to be a major surgery that required a prolonged inpatient stay has become an outpatient procedure where patients are discharged home a few hours after the operation.3 Although the recovery period is shorter than in the past, there are still some postoperative complaints that are relatively common, and can impair quality of life. One of them is postoperative vaginal bleeding. Although this can be a sign of a more serious problem such as vaginal cuff dehiscence, the grand majority of times it is related to granulation tissue in the vaginal cuff that although may be self-limiting, can be bothersome and concerning to patients. Not only does this bleeding impair quality of life, but it's one of the most common reasons for emergency room visits after surgery. Multiple studies have shown that postoperative vaginal bleeding and return to the hospital significantly affect patient satisfaction. 4,5 Anecdotally, bleeding originates from granulation tissue at the angles of the closure, although there hasn't been any studies specifically investigating this. A common approach to laparoscopic cuff closure involves a running barbed suture, with or without separate closure of the lateral angles.6,7 Recently, laparoscopic closure of the vaginal cuff was found to be superior when compared to vaginal closure in terms of vaginal cuff dehiscence8. This RCT also evaluated vaginal cuff bleeding as a secondary outcome, but this was recorded as he presence of bleeding at 3 months after surgery. The closure technique in this study was a running non-barbed suture, without independent suturing of the angles. Although a running suture placed laparoscopically may provide adequate tensile strength throughout the cuff to promote healing, the tension at the corners may be less than at the center when using barbed suture, hence potentially increasing the risk of bleeding. Furthermore, the second angle may be more difficult to access when the remainder of the cuff is re-approximated.

The investigators propose prospectively evaluating if adding separate sutures to the angles of the vaginal cuff before running barbed suture reduces the incidence of patient's perception of bleeding after surgery.

Eligibility criteria: Inclusion Criteria:

* • Pre-menopausal patients scheduled to undergo hysterectomy via laparoscopic/robotic approach for benign indications (Ages 18-60, who have had at least one menstrual cycle in the last year).

Exclusion Criteria:

* Patient's that incur in an intraoperative bowel or urologic injury during the hysterectomy that requires repair. If injury occurs after randomization (during vaginal cuff closure), this will be recorded and reviewed by the study's safety officer

  * Patients scheduled to undergo a concomitant vaginal procedure (Mid-urethral sling, anterior/posterior repair)
  * Patients scheduled to undergo pelvic floor repair (utero-sacral ligament suspension)
  * Patients with known preoperative malignancy
  * Patients in which a total hysterectomy is not completed

Primary outcomes:
measure: pain quantification on 0-10 scale
timeFrame: 10-20 days post intervention
measure: postoperative bleeding frequency
timeFrame: 10-20 days post intervention
measure: prolonged bleeding
timeFrame: 90-110 days after intervention
measure: postoperative bleeding volume
timeFrame: 10-20 days post intervention
Secondary outcomes:
measure: Pain with sex on a 0-10 scale
timeFrame: 90-110 days after intervention
measure: ER visits
timeFrame: 90-110 days
measure: Physical functioningSF36
timeFrame: 90-110 days
measure: PainSF36
timeFrame: 90-110 days
measure: General healthSF36
timeFrame: 90-110 days
measure: Role limitations due to physical healthSF36
timeFrame: 90-110 days
measure: Operative time
timeFrame: During the surgery. Start time begins when first suture and sewing instruments are in abdomen with the intention of closing vaginal cuff. Stop time is when last suture pertaining to vaginal cuff closure/apex stitches is cut.
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Scince Center El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health and Sciences Center
name: Steven Radtke, MD
role: PRINCIPAL_INVESTIGATOR
References: