Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
NCT ID: NCT03038945
Last Updated: 2017-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
150 participants
INTERVENTIONAL
2016-10-31
2016-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy
NCT05833204
Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy
NCT02998658
Barbed Suture vs Smooth Suture for Vaginal Cuff Closure
NCT01262573
Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy
NCT01814579
Vaginal Cuff Closure in Robotic Hysterectomy
NCT02696239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2/0 barbed suture
Use barbed suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
2/0 barbed suture
Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology
Vicryl suture
Use VICRYL suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
0/0 Vicryl suture
Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
2/0 barbed suture
Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology
0/0 Vicryl suture
Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients ASA (American Society of Anesthesiologists) 1 and 2
* Patients who are able to communicate by telephone and answer questions
Exclusion Criteria
* Endometriosis III / IV
* Patients who can not be reached by phone
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CES University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Claudia López
Gynecologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
CLAUDIA LOPEZ, Gynecologist
Role: PRINCIPAL_INVESTIGATOR
CLINICA DEL PRADO
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Claudia Lopez
Medellín, Antioquia, Colombia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Blikkendaal MD, Twijnstra AR, Pacquee SC, Rhemrev JP, Smeets MJ, de Kroon CD, Jansen FW. Vaginal cuff dehiscence in laparoscopic hysterectomy: influence of various suturing methods of the vaginal vault. Gynecol Surg. 2012 Nov;9(4):393-400. doi: 10.1007/s10397-012-0745-5. Epub 2012 May 3.
ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.
Hur HC, Guido RS, Mansuria SM, Hacker MR, Sanfilippo JS, Lee TT. Incidence and patient characteristics of vaginal cuff dehiscence after different modes of hysterectomies. J Minim Invasive Gynecol. 2007 May-Jun;14(3):311-7. doi: 10.1016/j.jmig.2006.11.005.
Kho RM, Akl MN, Cornella JL, Magtibay PM, Wechter ME, Magrina JF. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Aug;114(2 Pt 1):231-235. doi: 10.1097/AOG.0b013e3181af36e3.
Villa MT, White LE, Alam M, Yoo SS, Walton RL. Barbed sutures: a review of the literature. Plast Reconstr Surg. 2008 Mar;121(3):102e-108e. doi: 10.1097/01.prs.0000299452.24743.65.
Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
377
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.