Genital ProlapseNCT04856709
Abdominal Pectopexy Versus Abdominal Sacral Hysteropexy.
A study testing Abdominal Pectopexy and Abdominal Sacral Hysteropexy in people with Genital Prolapse, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare between abdominal pectopexy and abdominal sacral hysteropexy in terms of efficacy (assessed by POP-Q system), intra and postoperative complications. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Genital Prolapse
- What is being tested?
- Abdominal Pectopexy and Abdominal Sacral Hysteropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Apr 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with stage 2 to 4 uterine prolapse.
- BMI from ≤ 35 kg\m2.
- Women of any parity including nulliparas will be included.
- Age of female patients ranges from 20 to 40 years.
Who cannot join
- Previous correction of apical prolapse.
- Inoperable co-existing uterine pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abdominal Pectopexy Versus Abdominal Sacral Hysteropexy as Conservative Surgeries for Genital Prolapse: A Randomized Control Trial
This study aims to compare between abdominal pectopexy and abdominal sacral hysteropexy in terms of efficacy (assessed by POP-Q system), intra and postoperative complications.
Read the detailed description
Pelvic organ prolapse (POP), the herniation of the pelvic organs to or beyond the vaginal walls, is a common condition. Many women with prolapse experience symptoms that impact daily activities, sexual function, and exercise. The presence of POP can have a detrimental impact on body image and sexuality (Lowder et al., 2011). Nulliparous prolapse is reported to account for 1.5% to 2% of all cases of genital prolapse (Virkud, 2016). The incidence rises to 5 -8 % for young women who have delivered one or two children. As this type of prolapse occurs at a younger age, the surgical technique should not only reduce the prolapse but also retain the reproductive function. Various conservative surgeries have been described in the past, each having their own merits and de-merits (Rameshkumar et al., 2017).
Pelvic organ prolapse (POP) is affecting women of all ages. Epidemiological studies suggest a lifetime risk of prolapse or incontinence surgery of between 7 and 19% (Olsen et al., 1997; Smith et al., 2010). In an ageing population, the incidence of these surgeries would only be expected to increase, although the increasing Caesarean Section rates and smaller family size in recent years will have a negative impact on the prevalence of these conditions. There are many approaches to the surgical correction of POP, which frequently reflect the nature and anatomical site of the defective support, but essentially the surgeon has to decide whether to perform this surgery vaginally or via the abdomen as an open or laparoscopic procedure. If performed vaginally, further decisions regarding the use of synthetic or biological graft to reinforce the repair need to be made (Cvach and Dwyer, 2012).
Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension. This new method is considered a simple, safe procedure, especially in patients whose surgical exploration is difficult (Banerjee and Noé, 2011).
This method uses the iliopectineal ligament on both sides for the mesh fixation, (Banerjee and Noé, 2011). so there is no restriction caused by the mesh. The mesh follows natural structures (round and broad ligaments) without crossing sensitive spots, such as the ureter or bowel. The hypogastric trunk is at a safe distance and out of danger.
The iliopectineal ligament is an extension of the lacunar ligament that runs on the pectineal line of the pubic bone (Faure et al., 2001), and is significantly stronger than the sacrospinous ligament and the arcus tendineus of the pelvic fascia (Cosson et al., 2003). The structure is strong, and holds suture well Abdominal sacral hysteropexy remains a viable alternative for women undergoing pelvic reconstructive surgery who wish to retain their uteri, providing comparable rates of overall improvement and symptom change. Avoiding hysterectomy decreases the risk of mesh erosion but may increase the risk of subsequent recurrent prolapse, specifically in the anterior compartment (Cvach and Cundiff, 2008).
Although sacrocolpopexy has been the most effective option over time, the procedure is still associated with some problems, and the most frequently reported complications include defecation disorders and stress urinary incontinence (SUI)
- Conditions
- Genital Prolapse
- Being tested
- Abdominal Pectopexy, Abdominal Sacral Hysteropexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal PectopexyProcedure or surgery
Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension.
Abdominal Sacral HysteropexyProcedure or surgery
Abdominal sacrocolpopexy is a procedure that uses a mesh material to support the top of the vagina to treat pelvic prolapse.
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | Women with stage 2 to 4 uterine prolapse. BMI from ≤ 35 kg\m2. Women of any parity including nulliparas will be included. Age of female patients ranges from 20 to 40 years. Receives: Procedure: Abdominal Pectopexy; Procedure: Abdominal Sacral Hysteropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy, After the procedure there will be follow up visits at 3 months to detect the efficacy of the procedure by using POP-Q system.
The POP-Q system is a technique that measures compartment prolapse relative to the anatomic landmark of the hymen.Prolapse points proximal to the hymen are given a negative value, whereas positive values are given to points that protrude past the hymen. 6 points are delineated, including two on the anterior vaginal wall (Aa, Ba), two on the vaginal apex (C, D), and two on the posterior vaginal wall (Ap, Bp). Points Gh, Pb, and TVL describe the genital hiatus, perineal body, and total vaginal length, respectively.
- Stage 0: no demonstrable prolapse
- Stage 1: the most distal portion of the prolapsed segment is >1 cm above the level of the hymen
- Stage 2: the most distal portion of the prolapsed segment is >1 cm or less proximal or distal to the hymen
- Stage 3: the most distal portion of the prolapsed segment protrudes >1 cm below the hymen but 2 cm less than the total length of the vagina
- Stage 4: complete eversion of the vagina
Measured: 3 months
Secondary outcomes (5)
Operative time
Total operative time from skin incision till closure of the skin and excluding time of concomitant surgical procedures.
Measured: 60- 240 minutes
Intra operative blood loss
Intra operative blood loss will be estimated via:
Amount of blood in suction bottle. Drop in postoperative hemoglobin and hematocrit when compared with preoperative values
Measured: 60- 240 minutes
Intra operative complications
Intra operative complications including:
- Need for blood transfusion.
- Bowel or bladder injury.
Measured: 60- 240 minutes
Post operative complications
- Subfascial hematoma or pelvic hematoma.
- Surgical site infection.
- Urinary tract infection.
- Need for post-operative blood transfusion.
- Postoperative bowel or urinary tract complications
Measured: 1 week
Post operative pain
Postoperative pain will be assessed using the linear 10cm visual analogue scale. Range is from 10(unbearable pain) to zero (no pain).
Measured: after 6 hours, 12 hours and 24 hours from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital ProlapseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * Study design: Randomized Controlled clinical Trial * Study Setting: Ain Shams maternity hospital. * Study Population: The study included 80 women divided into 2 groups: Group A: 40 women underwent abdominal pectopexy. Group B: 40 women underwent abdominal sacral hysteropexy.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856709
- Sponsor's protocol ID
- Pectopexy
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Pectopexy Versus Abdominal Sacral Hysteropexy as Conservative Surgeries for Genital Prolapse: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04856709
- Acronym / sponsor ID
- Pectopexy
- Conditions
- Genital Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 23 Apr 2021 (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.
This study aims to compare between abdominal pectopexy and abdominal sacral hysteropexy in terms of efficacy (assessed by POP-Q system), intra and postoperative complications.
Detailed description
Pelvic organ prolapse (POP), the herniation of the pelvic organs to or beyond the vaginal walls, is a common condition. Many women with prolapse experience symptoms that impact daily activities, sexual function, and exercise. The presence of POP can have a detrimental impact on body image and sexuality (Lowder et al., 2011). Nulliparous prolapse is reported to account for 1.5% to 2% of all cases of genital prolapse (Virkud, 2016). The incidence rises to 5 -8 % for young women who have delivered one or two children. As this type of prolapse occurs at a younger age, the surgical technique should not only reduce the prolapse but also retain the reproductive function. Various conservative surgeries have been described in the past, each having their own merits and de-merits (Rameshkumar et al., 2017).
Pelvic organ prolapse (POP) is affecting women of all ages. Epidemiological studies suggest a lifetime risk of prolapse or incontinence surgery of between 7 and 19% (Olsen et al., 1997; Smith et al., 2010). In an ageing population, the incidence of these surgeries would only be expected to increase, although the increasing Caesarean Section rates and smaller family size in recent years will have a negative impact on the prevalence of these conditions. There are many approaches to the surgical correction of POP, which frequently reflect the nature and anatomical site of the defective support, but essentially the surgeon has to decide whether to perform this surgery vaginally or via the abdomen as an open or laparoscopic procedure. If performed vaginally, further decisions regarding the use of synthetic or biological graft to reinforce the repair need to be made (Cvach and Dwyer, 2012).
Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension. This new method is considered a simple, safe procedure, especially in patients whose surgical exploration is difficult (Banerjee and Noé, 2011).
This method uses the iliopectineal ligament on both sides for the mesh fixation, (Banerjee and Noé, 2011). so there is no restriction caused by the mesh. The mesh follows natural structures (round and broad ligaments) without crossing sensitive spots, such as the ureter or bowel. The hypogastric trunk is at a safe distance and out of danger.
The iliopectineal ligament is an extension of the lacunar ligament that runs on the pectineal line of the pubic bone (Faure et al., 2001), and is significantly stronger than the sacrospinous ligament and the arcus tendineus of the pelvic fascia (Cosson et al., 2003). The structure is strong, and holds suture well Abdominal sacral hysteropexy remains a viable alternative for women undergoing pelvic reconstructive surgery who wish to retain their uteri, providing comparable rates of overall improvement and symptom change. Avoiding hysterectomy decreases the risk of mesh erosion but may increase the risk of subsequent recurrent prolapse, specifically in the anterior compartment (Cvach and Cundiff, 2008).
Although sacrocolpopexy has been the most effective option over time, the procedure is still associated with some problems, and the most frequently reported complications include defecation disorders and stress urinary incontinence (SUI)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Study design: Randomized Controlled clinical Trial * Study Setting: Ain Shams maternity hospital. * Study Population: The study included 80 women divided into 2 groups: Group A: 40 women underwent abdominal pectopexy. Group B: 40 women underwent abdominal sacral hysteropexy.
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Procedure: Abdominal Pectopexy, Procedure: Abdominal Sacral HysteropexyWomen with stage 2 to 4 uterine prolapse. BMI from ≤ 35 kg\m2. Women of any parity including nulliparas will be included. Age of female patients ranges from 20 to 40 years. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with stage 2 to 4 uterine prolapse.
- BMI from ≤ 35 kg\m2.
- Women of any parity including nulliparas will be included.
- Age of female patients ranges from 20 to 40 years.
Key exclusion criteria (2 listed)
- Previous correction of apical prolapse.
- Inoperable co-existing uterine pathology
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 |
|---|---|---|
| Abdominal PectopexyPectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension. | Procedure or surgery | study group |
| Abdominal Sacral HysteropexyAbdominal sacrocolpopexy is a procedure that uses a mesh material to support the top of the vagina to treat pelvic prolapse. | Procedure or surgery | study group |
Primary outcome
Efficacy, After the procedure there will be follow up visits at 3 months to detect the efficacy of the procedure by using POP-Q system.
Time frame: 3 months
The POP-Q system is a technique that measures compartment prolapse relative to the anatomic landmark of the hymen.Prolapse points proximal to the hymen are given a negative value, whereas positive values are given to points that protrude past the hymen. 6 points are delineated, including two on the anterior vaginal wall (Aa, Ba), two on the vaginal apex (C, D), and two on the posterior vaginal wall (Ap, Bp). Points Gh, Pb, and TVL describe the genital hiatus, perineal body, and total vaginal length, respectively. * Stage 0: no demonstrable prolapse * Stage 1: the most distal portion of the prolapsed segment is >1 cm above the level of the hymen * Stage 2: the most distal portion of the prolapsed segment is >1 cm or less proximal or distal to the hymen * Stage 3: the most distal portion of the prolapsed segment protrudes >1 cm below the hymen but 2 cm less than the total length of the vagina * Stage 4: complete eversion of the vagina
5 secondary outcomes
Operative time
Time frame: 60- 240 minutes
Intra operative blood loss
Time frame: 60- 240 minutes
Intra operative complications
Time frame: 60- 240 minutes
Post operative complications
Time frame: 1 week
Post operative pain
Time frame: after 6 hours, 12 hours and 24 hours from the 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 23 Apr 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Pectopexy and Abdominal Sacral Hysteropexy in people with Genital Prolapse, run by Ain Shams 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 4 inclusion and 2 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 23 Apr 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?
Efficacy, After the procedure there will be follow up visits at 3 months to detect the efficacy of the procedure by using POP-Q system. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2021.