Prolapse GenitalNCT04178473
Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy
A study testing total abdominal hysterectomy and Subtotal abdominal hysterectomy in people with Prolapse Genital, run by South Valley University at 1 site in Egypt.
Trial summary
Uterovaginal prolapse is a common disease. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Prolapse Genital
- What is being tested?
- total abdominal hysterectomy and Subtotal abdominal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 May 2021
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nonhystrectomized patients who will undergo sacrocolpopexy for uterovaginal prolapse
Who cannot join
- women age less than 40
- desire to retain the uterus
- women who are unfit for lengthy surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department
Qina, Qena Governorate
About this study
Uterovaginal prolapse is a common disease. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women.
In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.
Study design: Randomized controlled trial
Intervention:
Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy
Read the detailed description
Uterovaginal prolapse is a common disease. Sacrocolpopexy is essentially invented to manage prolapse of the vault following hysterectomy. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women. The main drawback of sacrocolpopexy is the risk of mesh erosion. The incidence of mesh erosion is 0-5% at follow up of 1 year and 0.5% at follow up of 7 years. After total hysterectomy, the mesh is sutured to the vaginal wall using non-absorbable sutures. Sutures that span the whole thickness of vaginal and involve the vaginal skin was considered the probable factor that result in mesh erosion. After subtotal hysterectomy, the mesh is fixed to the anterior and the posterior cervical surfaces. The cervix has thick wall and the risk associated with "deep" stiches does not exist.
In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.
Patients and methods
Study design:
Randomized controlled trial
Patients:
Data will be collected from the patients admitted to the obstetrics and gynecology department, Qen faculty of medicine, South Valley University, Egypt from the 1st of January 2019 until 30th of December 2019. Follow up data will be collected until 30th of December 2020. Written consent will be obtained at time of recruitment. The Inclusion criteria are nonhystrectomized patients who will undergo sacrocolpopexy. Exclusion criteria were (1) women age less than 40; (2) desire to retain the uterus; (3) women who are unfit for lengthy surgery. Randomization will be through closed envelop method.
Intervention Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy Sacrocolpopexy will be done using Polypropylene mesh. Both groups will be done by the same surgeon using the following technique: dissection of the vesicovaginal and the rectovaginal spaces to prepare for the site of mesh placement. Dissection will be continued in the rectovaginal septum using sharp and blunt dissection until reaching the level of the levator ani (the length of the posterior vaginal mesh arm is nearly equal to the total vaginal length). The limit of the dissection in the vesicovaginal plane is down to the bladder neck (known by palpation of the Foley's catheter balloon) after lateralization of the ureters. The mesh is sutured to the anterior and the posterior vaginal wall the mesh using non-absorbable sutures. In women with subtotal hysterectomy, the mesh will be also sutured to the cervix. The mesh is then sutured to the anterior longitudinal ligament on the anterior surface of the fifth lumbar vertebra and the sacral promontory using non-absorbable sutures. Suturing of the peritoneum over the mesh will be done.
Outcomes:
The primary outcome will be mesh erosion. Secondary outcomes will be complications including recurrence
- Conditions
- Prolapse Genital
- Being tested
- total abdominal hysterectomy, Subtotal abdominal hysterectomy
- Keywords
- hysterectomy, sacrocolpopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total abdominal hysterectomyProcedure or surgery
total abdominal hysterectomy at time of sacrocolpopexy
Subtotal abdominal hysterectomyProcedure or surgery
Subtotal abdominal hysterectomy at time of sacrocolpopexy
| Study group | Role | What they receive |
|---|---|---|
| total abdominal hysterectomy | Active comparator | Total abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse Receives: Procedure: total abdominal hysterectomy |
| subtotal abdominal hysterectomy | Active comparator | subtotal abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse Receives: Procedure: Subtotal abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesh erosion
Mesh exposure through the lumen of the vagina, bladder, or rectum
Measured: 12 months or more
Secondary outcomes (1)
recurrence
recurrence of vaginal wall prolapse or vault prolapse
Measured: 12 months or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jan 2019
- Primary completion30 Jan 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prolapse GenitalStudies 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
- Parallel groups
- Model description
- Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy Sacrocolpopexy will be done using Polypropylene mesh for all women with uterovaginal prolapse
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Abdel-Rahman Mohammad Ahmed, South Valley University
- Investigators
- Mohammad AM Ahmed, MD, Principal investigator, South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178473
- Sponsor's protocol ID
- OBGYN 0101
- Status last verified
- Sep 2021
- First submitted
- 24 Nov 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared in unanonomous manner with the predetermined group of researchers
Publications
Barrington JW, Edwards G. Posthysterectomy vault prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):241-5. doi: 10.1007/s001920070033.
PubMed 11005477Cayrac M, Warembourg S, Le Normand L, Fatton B. [Does hysterectomy modifies the anatomical and functional outcomes of prolapse surgery?: Clinical Practice Guidelines]. Prog Urol. 2016 Jul;26 Suppl 1:S73-88. doi: 10.1016/S1166-7087(16)30430-4. French.
PubMed 27595628Coolen AWM, Bui BN, Dietz V, Wang R, van Montfoort APA, Mol BWJ, Roovers JWR, Bongers MY. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J. 2017 Dec;28(12):1767-1783. doi: 10.1007/s00192-017-3493-2. Epub 2017 Oct 16.
PubMed 29038834Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.1016/j.ajog.2008.07.029. Epub 2008 Oct 31.
PubMed 18976976Ismail S, Duckett J, Rizk D, Sorinola O, Kammerer-Doak D, Contreras-Ortiz O, Al-Mandeel H, Svabik K, Parekh M, Phillips C. Recurrent pelvic organ prolapse: International Urogynecological Association Research and Development Committee opinion. Int Urogynecol J. 2016 Nov;27(11):1619-1632. doi: 10.1007/s00192-016-3076-7. Epub 2016 Jul 5.
PubMed 27379891
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT04178473
- Acronym / sponsor ID
- OBGYN 0101
- Conditions
- Prolapse Genital
- Keywords
- hysterectomy, sacrocolpopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
Uterovaginal prolapse is a common disease. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women.
In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.
Study design: Randomized controlled trial
Intervention:
Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy
Detailed description
Uterovaginal prolapse is a common disease. Sacrocolpopexy is essentially invented to manage prolapse of the vault following hysterectomy. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women. The main drawback of sacrocolpopexy is the risk of mesh erosion. The incidence of mesh erosion is 0-5% at follow up of 1 year and 0.5% at follow up of 7 years. After total hysterectomy, the mesh is sutured to the vaginal wall using non-absorbable sutures. Sutures that span the whole thickness of vaginal and involve the vaginal skin was considered the probable factor that result in mesh erosion. After subtotal hysterectomy, the mesh is fixed to the anterior and the posterior cervical surfaces. The cervix has thick wall and the risk associated with "deep" stiches does not exist.
In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy.
Patients and methods
Study design:
Randomized controlled trial
Patients:
Data will be collected from the patients admitted to the obstetrics and gynecology department, Qen faculty of medicine, South Valley University, Egypt from the 1st of January 2019 until 30th of December 2019. Follow up data will be collected until 30th of December 2020. Written consent will be obtained at time of recruitment. The Inclusion criteria are nonhystrectomized patients who will undergo sacrocolpopexy. Exclusion criteria were (1) women age less than 40; (2) desire to retain the uterus; (3) women who are unfit for lengthy surgery. Randomization will be through closed envelop method.
Intervention Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy Sacrocolpopexy will be done using Polypropylene mesh. Both groups will be done by the same surgeon using the following technique: dissection of the vesicovaginal and the rectovaginal spaces to prepare for the site of mesh placement. Dissection will be continued in the rectovaginal septum using sharp and blunt dissection until reaching the level of the levator ani (the length of the posterior vaginal mesh arm is nearly equal to the total vaginal length). The limit of the dissection in the vesicovaginal plane is down to the bladder neck (known by palpation of the Foley's catheter balloon) after lateralization of the ureters. The mesh is sutured to the anterior and the posterior vaginal wall the mesh using non-absorbable sutures. In women with subtotal hysterectomy, the mesh will be also sutured to the cervix. The mesh is then sutured to the anterior longitudinal ligament on the anterior surface of the fifth lumbar vertebra and the sacral promontory using non-absorbable sutures. Suturing of the peritoneum over the mesh will be done.
Outcomes:
The primary outcome will be mesh erosion. Secondary outcomes will be complications including recurrence
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy Sacrocolpopexy will be done using Polypropylene mesh for all women with uterovaginal prolapse
| Arm | Type | Receives |
|---|---|---|
| total abdominal hysterectomy | Active comparator | Procedure: total abdominal hysterectomyTotal abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse |
| subtotal abdominal hysterectomy | Active comparator | Procedure: Subtotal abdominal hysterectomysubtotal abdominal hysterectomy at the time of sacrocolpopexy operation for uterovaginal prolapse |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nonhystrectomized patients who will undergo sacrocolpopexy for uterovaginal prolapse
Key exclusion criteria (3 listed)
- women age less than 40
- desire to retain the uterus
- women who are unfit for lengthy surgery
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 |
|---|---|---|
| total abdominal hysterectomytotal abdominal hysterectomy at time of sacrocolpopexy | Procedure or surgery | total abdominal hysterectomy |
| Subtotal abdominal hysterectomySubtotal abdominal hysterectomy at time of sacrocolpopexy | Procedure or surgery | subtotal abdominal hysterectomy |
Primary outcome
Mesh erosion
Time frame: 12 months or more
Mesh exposure through the lumen of the vagina, bladder, or rectum
1 secondary outcome
recurrence
Time frame: 12 months or more
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 21 Sep 2021.
- Background: PubMed 11005477Barrington JW, Edwards G. Posthysterectomy vault prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11(4):241-5. doi: 10.1007/s001920070033.
- Background: PubMed 27595628Cayrac M, Warembourg S, Le Normand L, Fatton B. [Does hysterectomy modifies the anatomical and functional outcomes of prolapse surgery?: Clinical Practice Guidelines]. Prog Urol. 2016 Jul;26 Suppl 1:S73-88. doi: 10.1016/S1166-7087(16)30430-4. French.
- Background: PubMed 29038834Coolen AWM, Bui BN, Dietz V, Wang R, van Montfoort APA, Mol BWJ, Roovers JWR, Bongers MY. The treatment of post-hysterectomy vaginal vault prolapse: a systematic review and meta-analysis. Int Urogynecol J. 2017 Dec;28(12):1767-1783. doi: 10.1007/s00192-017-3493-2. Epub 2017 Oct 16.
- Background: PubMed 18976976Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.1016/j.ajog.2008.07.029. Epub 2008 Oct 31.
- Background: PubMed 27379891Ismail S, Duckett J, Rizk D, Sorinola O, Kammerer-Doak D, Contreras-Ortiz O, Al-Mandeel H, Svabik K, Parekh M, Phillips C. Recurrent pelvic organ prolapse: International Urogynecological Association Research and Development Committee opinion. Int Urogynecol J. 2016 Nov;27(11):1619-1632. doi: 10.1007/s00192-016-3076-7. Epub 2016 Jul 5.
- Individual participant dataSharing planned: Yes. IPD will be shared in unanonomous manner with the predetermined group of researchers
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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.
Mohammad AM Ahmed, MD principal investigator
South Valley University, Qena Faculty of Medicine, Obstetrics and Gynecology Department, Qena, Qena, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total abdominal hysterectomy and Subtotal abdominal hysterectomy in people with Prolapse Genital, run by South Valley University at 1 site in Egypt.
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 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 21 Sep 2021. 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 Egypt. 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?
Mesh erosion (time frame: 12 months or more). 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 NCT04178473, which also lists 5 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 21 Sep 2021.