NCT03038945

Brief 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 dyspareunia. A prospective study will be conducted to compare two different techniques for closure of the vaginal vault.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

January 19, 2017

Last Update Submit

February 23, 2017

Conditions

Gynecologic Surgical Procedures

Keywords

LaparoscopyHysterectomySuture Techniques

Outcome Measures

Primary Outcomes (1)

  • Cuff closure time

    time spend for vaginal Cuff closure (in minutes)

    20 minutes

Secondary Outcomes (2)

  • Intra or postoperative complications

    10 days

  • Dyspareunia

    12 weeks

Study Arms (2)

2/0 barbed suture

EXPERIMENTAL

Use barbed suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology

Other: 2/0 barbed suture

Vicryl suture

ACTIVE COMPARATOR

Use VICRYL suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology

Other: 0/0 Vicryl suture

Interventions

2/0 barbed sutureOTHER

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

2/0 barbed suture
0/0 Vicryl sutureOTHER

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

Vicryl suture

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudia Lopez

MedellĂ­n, Antioquia, Colombia

Location

Related Publications (21)

  • 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.

    PMID: 22134014RESULT

  • 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.

    PMID: 21934442RESULT

  • 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.

    PMID: 21723030RESULT

  • 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.

    PMID: 21333192RESULT

  • 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.

    PMID: 21160140RESULT

  • 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.

    PMID: 19943055RESULT

  • 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.

    PMID: 21354068RESULT

  • 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.

    PMID: 21620360RESULT

  • 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.

    PMID: 12172223RESULT

  • 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.

    PMID: 16154253RESULT

  • 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.

    PMID: 14990423RESULT

  • 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.

    PMID: 20168105RESULT

  • 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.

    PMID: 21974989RESULT

  • 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.

    PMID: 22914459RESULT

  • 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.

    PMID: 22335453RESULT

  • 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.

    PMID: 23144640RESULT

  • 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.

    PMID: 20168127RESULT

  • 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.

    PMID: 17478361RESULT

  • 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.

    PMID: 19622982RESULT

  • 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.

    PMID: 18317092RESULT

  • Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.

    PMID: 21364859RESULT

Study Officials

  • CLAUDIA LOPEZ, Gynecologist

    CLINICA DEL PRADO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynecologist

Study Record Dates

First Submitted

January 19, 2017

First Posted

February 1, 2017

Study Start

October 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)