Complications of Medical CareNCT02696239
Vaginal Cuff Closure in Robotic Hysterectomy
A study testing Vaginal cuff closure in people with Complications of Medical Care, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of implementing different types of suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic hysterectomy on cost, operative time and post operative surgical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Complications of Medical Care
- What is being tested?
- Vaginal cuff closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women scheduled for robotic assisted laparoscopic hysterectomy
Who cannot join
- Patients who will not consent.
- Hysterectomy due to malignant conditions.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the impact of implementing different types of suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic hysterectomy on cost, operative time and post operative surgical outcomes.
Read the detailed description
Robotic assisted laparoscopic surgery is the fastest growing new modality in gynecologic surgery. Surgeons are adapting it to perform both benign and oncologic gynecologic procedures. Therefore, the fastest growing robotic procedure in the united states is hysterectomy.
The literature in laparoscopic hysterectomy, both robotic and non-robotic, reports a complication of vaginal closure disruption after hysterectomy higher than with abdominal surgery. Reasons hypothesized for this phenomenon include colpotomy (vaginal incision) technique, vaginal closure technique, and types of suture. At present, no further follow up studies have been done to test some of these hypothesis. In light of the rapid adoption of this approach to hysterectomy, more data on this issue will help the physician in counseling patients regarding complications, as well as helping surgeons choose materials and techniques in their hysterectomies which will diminish the chance for this unfortunate complication, which causes pain, hospitalization and excess morbidity after the original surgery.
Additionally, a parallel development of newer suturing materials, the so-called "barbed" self-anchoring sutures, typically fabricated from monofilament materials, have been reported used in laparoscopic hysterectomies in case series. The relative contribution of theses newer materials to the rates of cuff disruption is unknown.
The protocol proposes testing the null hypothesis that different suture materials and methods of closure do not cause a significant difference in the rates of vaginal cuff disruption after robotic assisted laparoscopic total hysterectomy.
Study design is a prospective randomized controlled trial. Patients will be blindly randomized to one of the 3 closure techniques using 3 different materials. Technique and material by necessity can not be blinded to the surgeon. Otherwise, standard surgical technique will be used. Followup in 2 and 6 weeks for clinical assessment will be performed. To asses the long term of cuff disruption, a 12 month interview will be also conducted. Data points will include operative time for closure, postoperative pain at 2 and 6 weeks, postoperative pain with urination/voiding at 2 and 6 weeks, spotting, bleeding and /or frank vaginal disruption documented at 2 and 6 weeks, and pain and presence of dyspareunia at 12 months will be assessed.
Cost associated with cuff closure will be calculated by addition of OR time and material cost.
- Conditions
- Complications of Medical Care
- Being tested
- Vaginal cuff closure
- Keywords
- vaginal cuff closure, Robotic Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal cuff closureProcedure or surgery
Vaginal cuff closure using V-loc sutures. This technique and material are standard of care for patients undergoing hysterectomy.
Vaginal cuff closureProcedure or surgery
Vaginal cuff closure using vicryl sutures. This technique and material are standard of care for patients undergoing hysterectomy.
Vaginal cuff closureProcedure or surgery
Vaginal cuff closure using Lapra-Ty II suture. This technique and material are standard of care for patients undergoing hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| V-lock suture | Active comparator | V-lock absorbable Wound Closure Device, by Covidien Receives: Procedure: Vaginal cuff closure |
| Vicryl suture | Active comparator | Vicryl suture by Ethicon Receives: Procedure: Vaginal cuff closure |
| Lapra-Ty II | Active comparator | Lapra-Ty II, Absorbable Suture Clip, by Ethicon Receives: Procedure: Vaginal cuff closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal cuff dehiscence
Postoperative inspection for vaginal cuff dehiscence
Measured: 12 months
Secondary outcomes (8)
Complications
Post-operative vaginal bleeding, bowel or urinary dysfunction
Measured: 6 weeks
Operative time costs
Measurement of operative time and determination of unit cost per surgery
Measured: 1 year
Suturing material costs
Comparison of the amount and type of suture utilized per surgery
Measured: 1 year
Operative suturing time
Time to complete Vaginal cuff closure
Measured: During surgery
Post operative pain
Visual Analog Scale
Measured: 6 weeks
Vaginal bleeding/ spotting
Presence of postoperative vaginal bleeding
Measured: 12 months
Resumption of sexual activity
Time to resumption of intercourse
Measured: 12 months
Dyspareunia
Assessment of Painful Intercourse
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startSep 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complications of Medical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Eisenstein, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696239
- Sponsor's protocol ID
- 6297
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2016
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. No abstract available.
PubMed 21059487Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
PubMed 18619922Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566.
PubMed 21333192Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002.
PubMed 21354068
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Cuff Closure in Robotic Hysterectomy
- ClinicalTrials.gov ID
- NCT02696239
- Acronym / sponsor ID
- 6297
- Conditions
- Complications of Medical Care
- Keywords
- vaginal cuff closure, Robotic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of implementing different types of suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic hysterectomy on cost, operative time and post operative surgical outcomes.
Detailed description
Robotic assisted laparoscopic surgery is the fastest growing new modality in gynecologic surgery. Surgeons are adapting it to perform both benign and oncologic gynecologic procedures. Therefore, the fastest growing robotic procedure in the united states is hysterectomy.
The literature in laparoscopic hysterectomy, both robotic and non-robotic, reports a complication of vaginal closure disruption after hysterectomy higher than with abdominal surgery. Reasons hypothesized for this phenomenon include colpotomy (vaginal incision) technique, vaginal closure technique, and types of suture. At present, no further follow up studies have been done to test some of these hypothesis. In light of the rapid adoption of this approach to hysterectomy, more data on this issue will help the physician in counseling patients regarding complications, as well as helping surgeons choose materials and techniques in their hysterectomies which will diminish the chance for this unfortunate complication, which causes pain, hospitalization and excess morbidity after the original surgery.
Additionally, a parallel development of newer suturing materials, the so-called "barbed" self-anchoring sutures, typically fabricated from monofilament materials, have been reported used in laparoscopic hysterectomies in case series. The relative contribution of theses newer materials to the rates of cuff disruption is unknown.
The protocol proposes testing the null hypothesis that different suture materials and methods of closure do not cause a significant difference in the rates of vaginal cuff disruption after robotic assisted laparoscopic total hysterectomy.
Study design is a prospective randomized controlled trial. Patients will be blindly randomized to one of the 3 closure techniques using 3 different materials. Technique and material by necessity can not be blinded to the surgeon. Otherwise, standard surgical technique will be used. Followup in 2 and 6 weeks for clinical assessment will be performed. To asses the long term of cuff disruption, a 12 month interview will be also conducted. Data points will include operative time for closure, postoperative pain at 2 and 6 weeks, postoperative pain with urination/voiding at 2 and 6 weeks, spotting, bleeding and /or frank vaginal disruption documented at 2 and 6 weeks, and pain and presence of dyspareunia at 12 months will be assessed.
Cost associated with cuff closure will be calculated by addition of OR time and material cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V-lock suture | Active comparator | Procedure: Vaginal cuff closureV-lock absorbable Wound Closure Device, by Covidien |
| Vicryl suture | Active comparator | Procedure: Vaginal cuff closureVicryl suture by Ethicon |
| Lapra-Ty II | Active comparator | Procedure: Vaginal cuff closureLapra-Ty II, Absorbable Suture Clip, by Ethicon |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women scheduled for robotic assisted laparoscopic hysterectomy
Key exclusion criteria (2 listed)
- Patients who will not consent.
- Hysterectomy due to malignant conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal cuff closureVaginal cuff closure using V-loc sutures. This technique and material are standard of care for patients undergoing hysterectomy. | Procedure or surgery | V-lock suture |
| Vaginal cuff closureVaginal cuff closure using vicryl sutures. This technique and material are standard of care for patients undergoing hysterectomy. | Procedure or surgery | Vicryl suture |
| Vaginal cuff closureVaginal cuff closure using Lapra-Ty II suture. This technique and material are standard of care for patients undergoing hysterectomy. | Procedure or surgery | Lapra-Ty II |
Primary outcome
Vaginal cuff dehiscence
Time frame: 12 months
Postoperative inspection for vaginal cuff dehiscence
8 secondary outcomes
Complications
Time frame: 6 weeks
Operative time costs
Time frame: 1 year
Suturing material costs
Time frame: 1 year
Operative suturing time
Time frame: During surgery
Post operative pain
Time frame: 6 weeks
Vaginal bleeding/ spotting
Time frame: 12 months
Resumption of sexual activity
Time frame: 12 months
Dyspareunia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 21059487AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. No abstract available.
- Background: PubMed 18619922Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
- Background: PubMed 21333192Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566.
- Background: PubMed 21354068Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Eisenstein, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal cuff closure in people with Complications of Medical Care, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal cuff dehiscence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696239, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.