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

N/A

Waitlist Available

Led By Steven Radtke, MD

Research Sponsored by Texas Tech University Health Sciences Center, El Paso

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90-110 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding extra stitches at the corners of the vaginal wound before using a special type of thread can reduce bleeding after a hysterectomy. The goal is to help patients recover better by preventing bothersome bleeding that often occurs after this surgery. This approach aims to make the wound stronger and less likely to bleed.

Eligible Conditions

Postoperative Hemorrhage
Complications
Patient Satisfaction
Operative Time

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

pain quantification on 0-10 scale

postoperative bleeding frequency

postoperative bleeding volume

+1 more

Secondary study objectives

ER visits

General healthSF36

Operative time

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Angle stitchExperimental Treatment1 Intervention

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 II: controlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angle stitch

2022

N/A

~120

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