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

NCT ID: NCT05174988

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-08-07

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.

Conditions

Postoperative Bleeding; Patient Satisfaction; Complications; Operative Time

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Angle stitch

If the allocation corresponds to "Angle stitch", surgeon will use 0 polyglactin 910 suture on a tapered needle to place figure of 8 sutures on both (left and right) apexes. Knot tying technique (intra-corporeal vs extracorporeal) will be up to surgeon preference. After this is completed, barbed suture will be used to re-approximate the remainder of the vaginal cuff from right to left, backtracking once at the end for reinforcement.

Group Type: EXPERIMENTAL

Angle stitch

Intervention Type: 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.

control

If the subject's group corresponds to "Control group", the surgeon will re-approximate the cuff in a standard fashion, using a running-barbed suture (2-0 V-LOC 90 with tapered needle), starting at the right apex, moving towards the left, and then back-tracking once to further reinforce the closure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Angle stitch

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Steven Radtke

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Radtke, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health and Sciences Center

Locations

Texas Tech University Health Scince Center El Paso

El Paso, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

E22006

Identifier Type: -

Identifier Source: org_study_id