AzTrials
AzTrials

Gynecologic Surgical ProceduresNCT03038945

Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

A study testing 2/0 barbed suture and 0/0 Vicryl suture in people with Gynecologic Surgical Procedures, run by CES University at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of the problems described for this procedure has to do with the closure of the vaginal vault, increased surgical time when suture laparoscopically, complications such as dehiscence of the dome, infections, hematomas and… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Gynecologic Surgical Procedures
What is being tested?
2/0 barbed suture and 0/0 Vicryl suture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteColombia
Study dates
Oct 2016to Nov 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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • All patients scheduled for total laparoscopic hysterectomy without other simultaneous procedures , for benign causes , who were agree to participate in the trial and give their written consent.
  • Patients ASA (American Society of Anesthesiologists) 1 and 2
  • Patients who are able to communicate by telephone and answer questions

Who cannot join

  • Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic obstructive pulmonary disease), collagen diseases, diabetes.
  • Endometriosis III / IV
  • Patients who can not be reached by phone

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Claudia Lopez

    Medellín, Antioquia

Other trials in Colombia

About this study

Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of the problems described for this procedure has to do with the closure of the vaginal vault, increased surgical time when suture laparoscopically, complications such as dehiscence of the dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare two different techniques for closure of the vaginal vault.

Being tested
2/0 barbed suture, 0/0 Vicryl suture
Keywords
Laparoscopy, Hysterectomy, Suture Techniques

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2/0 barbed sutureOther

    Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology

  • 0/0 Vicryl sutureOther

    Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology

Study groups in NCT03038945
Study groupRoleWhat they receive
2/0 barbed sutureExperimentalUse barbed suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
Receives: Other: 2/0 barbed suture
Vicryl sutureActive comparatorUse VICRYL suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
Receives: Other: 0/0 Vicryl suture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cuff closure time

    time spend for vaginal Cuff closure (in minutes)

    Measured: 20 minutes

Secondary outcomes (2)

  1. Intra or postoperative complications

    Clinical follow-up to complications during the surgery and ten days after, through questions and clinical exam.

    Measured: 10 days

  2. Dyspareunia

    the visual scale was used to analyze the dyspareunia

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03038945
Sponsor's protocol ID
377
Status last verified
Feb 2017
First submitted
19 Jan 2017
Last updated
24 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Cohen SL, Einarsson JI. Total and supracervical hysterectomy. Obstet Gynecol Clin North Am. 2011 Dec;38(4):651-61. doi: 10.1016/j.ogc.2011.09.002.

    PubMed 22134014

  • Hur HC, Donnellan N, Mansuria S, Barber RE, Guido R, Lee T. Vaginal cuff dehiscence after different modes of hysterectomy. Obstet Gynecol. 2011 Oct;118(4):794-801. doi: 10.1097/AOG.0b013e31822f1c92.

    PubMed 21934442

  • Ceccaroni M, Berretta R, Malzoni M, Scioscia M, Roviglione G, Spagnolo E, Rolla M, Farina A, Malzoni C, De Iaco P, Minelli L, Bovicelli L. Vaginal cuff dehiscence after hysterectomy: a multicenter retrospective study. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):308-13. doi: 10.1016/j.ejogrb.2011.05.013. Epub 2011 Jul 1.

    PubMed 21723030

  • Einarsson 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 21333192

  • Hwang JH, Lee JK, Lee NW, Lee KW. Vaginal cuff closure: a comparison between the vaginal route and laparoscopic suture in patients undergoing total laparoscopic hysterectomy. Gynecol Obstet Invest. 2011;71(3):163-9. doi: 10.1159/000316052. Epub 2010 Dec 14.

    PubMed 21160140

  • Jeung IC, Baek JM, Park EK, Lee HN, Kim CJ, Park TC, Lee YS. A prospective comparison of vaginal stump suturing techniques during total laparoscopic hysterectomy. Arch Gynecol Obstet. 2010 Dec;282(6):631-8. doi: 10.1007/s00404-009-1300-0. Epub 2009 Nov 27.

    PubMed 19943055

  • Siedhoff 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

  • Uccella S, Ghezzi F, Mariani A, Cromi A, Bogani G, Serati M, Bolis P. Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature. Am J Obstet Gynecol. 2011 Aug;205(2):119.e1-12. doi: 10.1016/j.ajog.2011.03.024. Epub 2011 Mar 22.

    PubMed 21620360

  • Ramirez PT, Klemer DP. Vaginal evisceration after hysterectomy: a literature review. Obstet Gynecol Surv. 2002 Jul;57(7):462-7. doi: 10.1097/00006254-200207000-00023.

    PubMed 12172223

  • Iaco PD, Ceccaroni M, Alboni C, Roset B, Sansovini M, D'Alessandro L, Pignotti E, Aloysio DD. Transvaginal evisceration after hysterectomy: is vaginal cuff closure associated with a reduced risk? Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):134-8. doi: 10.1016/j.ejogrb.2005.08.009. Epub 2005 Sep 8.

    PubMed 16154253

  • Croak AJ, Gebhart JB, Klingele CJ, Schroeder G, Lee RA, Podratz KC. Characteristics of patients with vaginal rupture and evisceration. Obstet Gynecol. 2004 Mar;103(3):572-6. doi: 10.1097/01.AOG.0000115507.26155.45.

    PubMed 14990423

  • Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol. 2009 Nov;114(5):1041-1048. doi: 10.1097/AOG.0b013e3181b9d222.

    PubMed 20168105

  • Cronin B, Sung VW, Matteson KA. Vaginal cuff dehiscence: risk factors and management. Am J Obstet Gynecol. 2012 Apr;206(4):284-8. doi: 10.1016/j.ajog.2011.08.026. Epub 2011 Aug 27.

    PubMed 21974989

  • Uccella S, Ceccaroni M, Cromi A, Malzoni M, Berretta R, De Iaco P, Roviglione G, Bogani G, Minelli L, Ghezzi F. Vaginal cuff dehiscence in a series of 12,398 hysterectomies: effect of different types of colpotomy and vaginal closure. Obstet Gynecol. 2012 Sep;120(3):516-23. doi: 10.1097/AOG.0b013e318264f848.

    PubMed 22914459

  • Chan WS, Kong KK, Nikam YA, Merkur H. Vaginal vault dehiscence after laparoscopic hysterectomy over a nine-year period at Sydney West Advanced Pelvic Surgery Unit - our experiences and current understanding of vaginal vault dehiscence. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):121-7. doi: 10.1111/j.1479-828X.2012.01411.x. Epub 2012 Feb 15.

    PubMed 22335453

Questions about this trial

What is this clinical trial studying?

A study testing 2/0 barbed suture and 0/0 Vicryl suture in people with Gynecologic Surgical Procedures, run by CES University at 1 site in Colombia.

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 3 inclusion and 3 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 24 Feb 2017. 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 Colombia. 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?

Cuff closure time (time frame: 20 minutes). 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 NCT03038945, which also lists 21 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 24 Feb 2017.

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