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Completed

NCT Number: NCT05174988

Reducing Postoperative Bleeding After Hysterectomy Via Independent Closure of Vaginal Cuff Angles

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Scince Center El Paso

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angle stitch

Procedure

Surgeon will use 0 polyglactin 910 suture on a tapered needle to place figure of 8 sutures on both (left and right) vaginal cuff apexes.

Primary outcomes

  1. pain quantification on 0-10 scale

    Time frame: 10-20 days post intervention

    Pelvic pain scale from 0-10 assessed at postoperative visit, with 10 representing worse pain imaginable, and 0 representing no pain

  2. postoperative bleeding frequency

    Time frame: 10-20 days post intervention

    Survey regarding postoperative vaginal bleeding- only if they are experiencing bleeding (categorical including Daily | Most days | Infrequent

  3. prolonged bleeding

    Time frame: 90-110 days after intervention

    yes or no if any vaginal bleeding in the last 2 weeks

  4. postoperative bleeding volume

    Time frame: 10-20 days post intervention

    Survey regarding postoperative vaginal bleeding- only if they are experiencing bleeding (categorical including Only when using restroom| Spotting throughout day | More than spotting

Secondary outcomes

  1. Pain with sex on a 0-10 scale

    Time frame: 90-110 days after intervention

    Subjective scoring per patient of pain during intercourse on a scale of 0-10, where 10 is worst pain imaginable and 0 is no pain.

  2. ER visits

    Time frame: 90-110 days

    emergency department visits related to surgery (yes or no)

  3. Physical functioningSF36

    Time frame: 90-110 days

    Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)

  4. PainSF36

    Time frame: 90-110 days

    Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)

  5. General healthSF36

    Time frame: 90-110 days

    Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)

  6. Role limitations due to physical healthSF36

    Time frame: 90-110 days

    Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)

  7. Operative time

    Time frame: 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.

    Vaginal cuff closure time in minutes recorded 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.

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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