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

Primary Purpose

Postoperative Bleeding, Patient Satisfaction, Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Angle stitch
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Bleeding focused on measuring bleeding, hysterectomy, cuff, closure

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Texas Tech University Health Scince Center El Paso

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Angle stitch

control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
postoperative bleeding frequency
Survey regarding postoperative vaginal bleeding- only if they are experiencing bleeding (categorical including Daily | Most days | Infrequent
prolonged bleeding
yes or no if any vaginal bleeding in the last 2 weeks
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

Secondary Outcome Measures

Pain with sex on a 0-10 scale
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.
ER visits
emergency department visits related to surgery (yes or no)
Physical functioningSF36
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
PainSF36
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
General healthSF36
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
Role limitations due to physical healthSF36
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
Operative time
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.

Full Information

First Posted
November 5, 2021
Last Updated
September 18, 2023
Sponsor
Texas Tech University Health Sciences Center, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT05174988
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
August 7, 2023 (Actual)
Study Completion Date
August 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Bleeding, Patient Satisfaction, Complications, Operative Time
Keywords
bleeding, hysterectomy, cuff, closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angle stitch
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angle stitch
Intervention Description
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 Outcome Measure Information:
Title
pain quantification on 0-10 scale
Description
Pelvic pain scale from 0-10 assessed at postoperative visit, with 10 representing worse pain imaginable, and 0 representing no pain
Time Frame
10-20 days post intervention
Title
postoperative bleeding frequency
Description
Survey regarding postoperative vaginal bleeding- only if they are experiencing bleeding (categorical including Daily | Most days | Infrequent
Time Frame
10-20 days post intervention
Title
prolonged bleeding
Description
yes or no if any vaginal bleeding in the last 2 weeks
Time Frame
90-110 days after intervention
Title
postoperative bleeding volume
Description
Survey regarding postoperative vaginal bleeding- only if they are experiencing bleeding (categorical including Only when using restroom| Spotting throughout day | More than spotting
Time Frame
10-20 days post intervention
Secondary Outcome Measure Information:
Title
Pain with sex on a 0-10 scale
Description
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.
Time Frame
90-110 days after intervention
Title
ER visits
Description
emergency department visits related to surgery (yes or no)
Time Frame
90-110 days
Title
Physical functioningSF36
Description
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
Time Frame
90-110 days
Title
PainSF36
Description
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
Time Frame
90-110 days
Title
General healthSF36
Description
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
Time Frame
90-110 days
Title
Role limitations due to physical healthSF36
Description
Calculated score Result from SF-36 (Short form-36 health survey) Range 0-100, with 100 representing the maximum of each particular outcome)
Time Frame
90-110 days
Title
Operative time
Description
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.
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only patients undergoing a hysterectomy are eligible
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Radtke, MD
Organizational Affiliation
Texas Tech University Health and Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Scince Center El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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