Surgical Wound DehiscenceNCT02453165
Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure
A study testing TRANSVAGINAL SUTURE and LAPAROSCOPIC SUTURE in people with Surgical Wound Dehiscence, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication. The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Wound Dehiscence
- What is being tested?
- TRANSVAGINAL SUTURE and LAPAROSCOPIC SUTURE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,408 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2015to 31 May 2017
- 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
- Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy
Who cannot join
- Patients with gynecological malignancy (uterine and/or adnexal)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Obstetrics and Gynecology Universita' Dell'Insubria
Varese, 21100
About this study
Official title: Randomized Clinical Trial About Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Suturing
Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.
The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.
Read the detailed description
A post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy.
The recognition of the complication is made on a clinical basis. The investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault.
The investigators will also compare the two modalities in terms of:
- duration of the vaginal closure
- risk of bleeding from the vaginal cuff
- risk of post-operative pelvic infection
- risk of re-operation
- dyspareunia
- total vaginal length
- vaginal cuff prolapse.
- Conditions
- Surgical Wound Dehiscence
- Being tested
- TRANSVAGINAL SUTURE, LAPAROSCOPIC SUTURE
- Keywords
- vaginal dehiscence
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRANSVAGINAL SUTUREProcedure or surgery
The closure of the vaginal cuff will be performed transvaginally using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with vaginal valves and needleholders
LAPAROSCOPIC SUTUREProcedure or surgery
The closure of the vaginal cuff will be performed laparoscopically using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with laparoscopic needleholders
| Study group | Role | What they receive |
|---|---|---|
| TRANSVAGINAL SUTURE | Experimental | INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders. Receives: Procedure: TRANSVAGINAL SUTURE |
| LAPAROSCOPIC SUTURE | Active comparator | INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic needleholders. Receives: Procedure: LAPAROSCOPIC SUTURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAGINAL DEHISCENCE
Vaginal dehiscence defined as any partial or complete separation of the vaginal vault, sutured at the end of a total laparoscopic hysterectomy.
This complication is diagnosed clinically, during a gynecologic visit. Every dehiscence (whether partial or total) will be considered as an outcome event and we will measure the presence/absence of dehiscence as a percentage of the total procedures.
Measured: 3 months postoperatively
Secondary outcomes (2)
VAGINAL CUFF COMPLICATIONS
- Vaginal bleeding
- Need for Vaginal re-suture
- Vaginal vault prolapse
- Dyspareunia
- Post-operative pelvic infection
Measured: 3 months postoperatively
operative time
Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically
Measured: During Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start1 Feb 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound DehiscenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Uccella, Università degli Studi dell'Insubria
- Investigators
- Stefano Uccella, MD, PhD, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453165
- Sponsor's protocol ID
- 440
- Status last verified
- Mar 2018
- First submitted
- 3 Feb 2015
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 21723030Hur 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 21934442Uccella 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 21620360Uccella 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 22914459Kim MJ, Kim S, Bae HS, Lee JK, Lee NW, Song JY. Evaluation of risk factors of vaginal cuff dehiscence after hysterectomy. Obstet Gynecol Sci. 2014 Mar;57(2):136-43. doi: 10.5468/ogs.2014.57.2.136. Epub 2014 Mar 15.
PubMed 24678487Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4.
PubMed 19588344Uccella S, Capozzi VA, Ricco' M, Perrone E, Zanello M, Ferrari S, Zorzato PC, Seracchioli R, Cromi A, Serati M, Ergasti R, Fanfani F, Berretta R, Malzoni M, Cianci S, Vizza E, Guido M, Legge F, Ciravolo G, Gueli Alletti S, Ghezzi F, Candiani M, Scambia G. Sexual Function following Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy: Secondary Analysis of a Randomized Trial by the Italian Society of Gynecological Endoscopy Using a Validated Questionnaire. J Minim Invasive Gynecol. 2020 Jan;27(1):186-194. doi: 10.1016/j.jmig.2019.03.018. Epub 2019 Apr 3.
PubMed 30951920
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial About Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Suturing
- ClinicalTrials.gov ID
- NCT02453165
- Acronym / sponsor ID
- 440
- Conditions
- Surgical Wound Dehiscence
- Keywords
- vaginal dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,408 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 25 May 2015 (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.
Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.
The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.
Detailed description
A post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy.
The recognition of the complication is made on a clinical basis. The investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault.
The investigators will also compare the two modalities in terms of:
- duration of the vaginal closure
- risk of bleeding from the vaginal cuff
- risk of post-operative pelvic infection
- risk of re-operation
- dyspareunia
- total vaginal length
- vaginal cuff prolapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRANSVAGINAL SUTURE | Experimental | Procedure: TRANSVAGINAL SUTUREINTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders. |
| LAPAROSCOPIC SUTURE | Active comparator | Procedure: LAPAROSCOPIC SUTUREINTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic needleholders. |
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)
- Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy
Key exclusion criteria (1 listed)
- Patients with gynecological malignancy (uterine and/or adnexal)
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 |
|---|---|---|
| TRANSVAGINAL SUTUREThe closure of the vaginal cuff will be performed transvaginally using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with vaginal valves and needleholders | Procedure or surgery | TRANSVAGINAL SUTURE |
| LAPAROSCOPIC SUTUREThe closure of the vaginal cuff will be performed laparoscopically using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with laparoscopic needleholders | Procedure or surgery | LAPAROSCOPIC SUTURE |
Primary outcome
VAGINAL DEHISCENCE
Time frame: 3 months postoperatively
Vaginal dehiscence defined as any partial or complete separation of the vaginal vault, sutured at the end of a total laparoscopic hysterectomy. This complication is diagnosed clinically, during a gynecologic visit. Every dehiscence (whether partial or total) will be considered as an outcome event and we will measure the presence/absence of dehiscence as a percentage of the total procedures.
2 secondary outcomes
VAGINAL CUFF COMPLICATIONS
Time frame: 3 months postoperatively
operative time
Time frame: During Operation
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 30 Mar 2018.
- Results publication: PubMed 21723030Ceccaroni 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.
- Results publication: PubMed 21934442Hur 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.
- Results publication: PubMed 21620360Uccella 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.
- Results publication: PubMed 22914459Uccella 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.
- Results publication: PubMed 24678487Kim MJ, Kim S, Bae HS, Lee JK, Lee NW, Song JY. Evaluation of risk factors of vaginal cuff dehiscence after hysterectomy. Obstet Gynecol Sci. 2014 Mar;57(2):136-43. doi: 10.5468/ogs.2014.57.2.136. Epub 2014 Mar 15.
- Results publication: PubMed 19588344Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4.
- Derived from this study: PubMed 30951920Uccella S, Capozzi VA, Ricco' M, Perrone E, Zanello M, Ferrari S, Zorzato PC, Seracchioli R, Cromi A, Serati M, Ergasti R, Fanfani F, Berretta R, Malzoni M, Cianci S, Vizza E, Guido M, Legge F, Ciravolo G, Gueli Alletti S, Ghezzi F, Candiani M, Scambia G. Sexual Function following Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy: Secondary Analysis of a Randomized Trial by the Italian Society of Gynecological Endoscopy Using a Validated Questionnaire. J Minim Invasive Gynecol. 2020 Jan;27(1):186-194. doi: 10.1016/j.jmig.2019.03.018. Epub 2019 Apr 3.
Related trials for Surgical Wound Dehiscence
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery
Cerebral Palsy
Recruiting
Skin Staples vs Polypropylene in Elective Laparotomy
Surgical Site Infection
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
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.
Stefano Uccella, MD, PhD principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRANSVAGINAL SUTURE and LAPAROSCOPIC SUTURE in people with Surgical Wound Dehiscence, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 1 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 30 Mar 2018. 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 Italy. 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 DEHISCENCE (time frame: 3 months postoperatively). 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 NCT02453165, which also lists 7 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 30 Mar 2018.