An interventional study of Angle stitch in Postoperative Bleeding, Patient Satisfaction and Complications, sponsored by Texas Tech University Health Sciences Center, El Paso. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Not applicable, Interventional, and Treatment
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 117 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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
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.
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.
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
Time frame: 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
Time frame: 10-20 days post intervention
prolonged bleeding
yes or no if any vaginal bleeding in the last 2 weeks
Time frame: 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
Time frame: 10-20 days post intervention
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.
Time frame: 90-110 days after intervention
ER visits
emergency department visits related to surgery (yes or no)
Time frame: 90-110 days
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)
Time frame: 90-110 days
PainSF36
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
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)
Time frame: 90-110 days
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)
Time frame: 90-110 days
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.
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.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Texas Tech University Health Sciences Center, El Paso