Postoperative ComplicationsNCT01645020
Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures
An observational study of Postoperative Complications, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postoperative Complications
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Jun 2013
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: women been operated at Western Galilee Hospital - Nahariya Israel
Who may be able to join
- Women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall.
Who cannot join
- Women with significant pre-operative pain
- Women with collagen diseases
- Women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall
Trial locations and contacts
1 site in 1 country.
About this study
Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.
Read the detailed description
Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones.
During the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used.
A polypropylene mesh (single strand and tunneling wide) trade name "Prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "Prolift +" M.
The number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.
- Conditions
- Postoperative Complications
- Keywords
- absorbable mesh, Partially absorbed Mesh, Prolift, Prolift + M, mesh related complications
- Medical subject headings
- Postoperative Complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startAug 2008
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- M Neuman, MD, Principal investigatorMenahem Neuman, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645020
- Sponsor's protocol ID
- 20
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khandwala S, Jayachandran C. Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial. Int Urogynecol J. 2011 Nov;22(11):1405-11. doi: 10.1007/s00192-011-1482-4. Epub 2011 Jul 1.
PubMed 21720912
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures
- ClinicalTrials.gov ID
- NCT01645020
- Acronym / sponsor ID
- 20
- Conditions
- Postoperative Complications
- Keywords
- absorbable mesh, Partially absorbed Mesh, Prolift, Prolift + M, mesh related complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Aug 2008
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 19 Jul 2012 (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.
Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.
Detailed description
Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones.
During the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used.
A polypropylene mesh (single strand and tunneling wide) trade name "Prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "Prolift +" M.
The number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women been operated at Western Galilee Hospital - Nahariya Israel
Key inclusion criteria (1 listed)
- Women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall.
Key exclusion criteria (3 listed)
- Women with significant pre-operative pain
- Women with collagen diseases
- Women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
- Background: PubMed 21720912Khandwala S, Jayachandran C. Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial. Int Urogynecol J. 2011 Nov;22(11):1405-11. doi: 10.1007/s00192-011-1482-4. Epub 2011 Jul 1.
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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.
M Neuman, MD principal investigator
Menahem Neuman principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 19 Jul 2012. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M Neuman, MD (972 3 956 3105, mneuman@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01645020, which also lists 1 linked publication.
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 19 Jul 2012.