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

NCT05174988 | Completed DMC

• 1 other identifier: E22006
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Bleeding; Patient Satisfaction; Complications; Operative Time

Keywords

bleeding; hysterectomy; cuff; closure

Outcome Measures

Primary Outcomes (4)

• pain quantification on 0-10 scale

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

  10-20 days post intervention

• postoperative bleeding frequency

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

  10-20 days post intervention

• prolonged bleeding

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

  90-110 days after intervention

• postoperative bleeding volume

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

  10-20 days post intervention

Secondary Outcomes (7)

• Pain with sex on a 0-10 scale

  90-110 days after intervention

• ER visits

  90-110 days

• Physical functioningSF36

  90-110 days

• PainSF36

  90-110 days

• General healthSF36

  90-110 days

Study Arms (2)

Angle stitch

EXPERIMENTAL

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.

Procedure: Angle stitch

control

NO INTERVENTION

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.

Interventions

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.

Angle stitch

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Only patients undergoing a hysterectomy are eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Scince Center El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Postoperative Hemorrhage; Patient Satisfaction; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Steven Radtke, MD

  Texas Tech University Health and Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: January 3, 2022
• Study Start: January 31, 2022
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)