Uterine NicheisthmoceleNCT04241107
Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial
A study testing Laparoscopic repair of Uterine niche and Transvaginal repair of Uterine niche in people with Uterine Niche, run by Assiut University at 1 site in Egypt.
Trial summary
The treatment of uterine niche ranges from clinical management with expectant or pharmacological treatment, surgical treatment. Approaches for repair include Laparotomy, laparoscopy , hysteroscopy , vaginal. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Uterine Niche
- What is being tested?
- Laparoscopic repair of Uterine niche and Transvaginal repair of Uterine niche
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2020to Mar 2022
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have uterine niche (defined as myometrial discontinuity or a hypoechoic triangle in the myometrium of the anterior uterine wall at the site of hysterotomy presented in transvaginal ultrasound or sonohysterography examination in non-pregnant women) ,with one or more previous caesarean section Who are:
- Symptomatic i.e patients having one or more of the following symptoms:
- Postmenstrual spotting (defined as more than 2 days of brownish discharge at the end of menstruation with a total length of menstruation (including spotting) of more than 7 days, or intermenstrual bleeding which starts within 5 days after the end of menstruation. [15]),
- Secondary Dysmenorrhea( defined as the pain or discomfort associated with menstruation)
- deep dyspareunia(deep genital pain associated with sexual intercourse)
- Chronic pelvic pain can be defined as intermittent or constant pain in the lower abdomen or pelvis of a woman of at least 6 months in duration, not occurring exclusively with menstruation or intercourse and not associated with pregnancy.
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- secondary infertility (defined by the World Health Organization as, -when a woman is unable to bear a child, either due to the inability to become pregnant or the inability to carry a pregnancy to a live birth following either a previous pregnancy or previous ability to carry a pregnancy to a live birth.)
- Asymptomatic patients with one of the followings:
- the residual myometrial thickness over the niche less than 3 mm previous history of Cesarean Section scar ectopic pregnancy (not managed by resection and repair)
- who accept to participate the study.
Who cannot join
- Asymptomatic patients with residual myometrial thickness more than 3 mm.
- No previous Cesarean section.
- If the patients symptoms presented before Cesarean section.
- Presence of other pathology that explain patient symptoms
- sub mucous fibroid
- cervical-Endometrial carcinoma
Show all 10Show fewer
- Endometrial hyperplasia
- Coagulation defect.
- Presence of pathology that necessitate laparotomy.
- Patient who refuse to participate the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Abdulrahman Muhammad Rageh
Asyut, 71111
Abdulrahman Muhammad Rageh, MSc, +201005056259, Abdulrahmanrageh.26.9@gmail.com
About this study
The treatment of uterine niche ranges from clinical management with expectant or pharmacological treatment, surgical treatment. Approaches for repair include Laparotomy, laparoscopy , hysteroscopy , vaginal. The decision to treat takes into consideration the size of the defect, presence of symptoms, secondary infertility and plans of pregnancy.
All of the approaches have its merits and debates. There is ongoing debate regarding the best surgical approach to managing this condition. To date no randomized controlled trials have been published to settle this debate.
Our study aim is to to evaluate which surgical approach is a preferable option, this study will be conducted to compare the Laparoscopic and transvaginal approaches in several regards, including, operation time, blood loss, perioperative complications, hospital stay length, postoperative increase in residual myometrial thickness during follow-up , clinical efficacy(percentage of patients who subject improvement of symptoms)
- Conditions
- Uterine Niche
- Being tested
- Laparoscopic repair of Uterine niche, Transvaginal repair of Uterine niche
- Keywords
- Cesarean Scar defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic repair of Uterine nicheProcedure or surgery
Repair of uterine niche through Laparoscopic approach.
Transvaginal repair of Uterine nicheProcedure or surgery
Repair of uterine niche through Transvaginal approach.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic approach group(A) | Active comparator | Uterine niche will be repaired through Laparoscopic approach. Receives: Procedure: Laparoscopic repair of Uterine niche |
| Transvaginal approach group(B) | Active comparator | Uterine niche will be repaired through Transvaginal approach. Receives: Procedure: Transvaginal repair of Uterine niche |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Number of patients who subject clinical improvement of pre-operative symptoms
Measured: 3 month postoperative
Post-operative increase in residual myometrial thickness
difference between pre-operative \& post-operative residual myometrial thickness
Measured: 3 month postoperative
Secondary outcomes (3)
Duration of operation
duration from anesthesia till end of operation
Measured: baseline( During operation)
Blood loss
estimated blood loss during operation(towels , suction container)
Measured: baseline( During operation)
Intra-operative complication
complication during the operation
Measured: baseline( During operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Uterine NicheStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Muhammad Rageh, Assiut University
- Investigators
- Mahmoud Abdel-Aleem, PhD, Study chair, Assiut UniversityMahmoud zakhera, PhD, Study chair, Assiut UniversityAhmed Abo El Fadle, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241107
- Sponsor's protocol ID
- Uterine niche repair
- Acronym
- isthmocele
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Betran AP, Torloni MR, Zhang JJ, Gulmezoglu AM; WHO Working Group on Caesarean Section. WHO Statement on Caesarean Section Rates. BJOG. 2016 Apr;123(5):667-70. doi: 10.1111/1471-0528.13526. Epub 2015 Jul 22. No abstract available.
PubMed 26681211Elnakib S, Abdel-Tawab N, Orbay D, Hassanein N. Medical and non-medical reasons for cesarean section delivery in Egypt: a hospital-based retrospective study. BMC Pregnancy Childbirth. 2019 Nov 8;19(1):411. doi: 10.1186/s12884-019-2558-2.
PubMed 31703638Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
PubMed 23996650Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.
PubMed 27393285Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
PubMed 26409016Sipahi S, Sasaki K, Miller CE. The minimally invasive approach to the symptomatic isthmocele - what does the literature say? A step-by-step primer on laparoscopic isthmocele - excision and repair. Curr Opin Obstet Gynecol. 2017 Aug;29(4):257-265. doi: 10.1097/GCO.0000000000000380.
PubMed 28598911van der Voet LF, Bij de Vaate AM, Veersema S, Brolmann HA, Huirne JA. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding. BJOG. 2014 Jan;121(2):236-44. doi: 10.1111/1471-0528.12542.
PubMed 24373597Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
PubMed 23680518Marotta ML, Donnez J, Squifflet J, Jadoul P, Darii N, Donnez O. Laparoscopic repair of post-cesarean section uterine scar defects diagnosed in nonpregnant women. J Minim Invasive Gynecol. 2013 May-Jun;20(3):386-91. doi: 10.1016/j.jmig.2012.12.006. Epub 2013 Jan 26.
PubMed 23357466Abacjew-Chmylko A, Wydra DG, Olszewska H. Hysteroscopy in the treatment of uterine cesarean section scar diverticulum: A systematic review. Adv Med Sci. 2017 Sep;62(2):230-239. doi: 10.1016/j.advms.2017.01.004. Epub 2017 May 10.
PubMed 28500899Ludwin A, Martins WP, Ludwin I. Evaluation of uterine niche by three-dimensional sonohysterography and volumetric quantification: techniques and scoring classification system. Ultrasound Obstet Gynecol. 2019 Jan;53(1):139-143. doi: 10.1002/uog.19181. No abstract available.
PubMed 30039641Zhang X, Yang M, Wang Q, Chen J, Ding J, Hua K. Prospective evaluation of five methods used to treat cesarean scar defects. Int J Gynaecol Obstet. 2016 Sep;134(3):336-9. doi: 10.1016/j.ijgo.2016.04.011. Epub 2016 Jun 30.
PubMed 27473332Donnez O, Jadoul P, Squifflet J, Donnez J. Laparoscopic repair of wide and deep uterine scar dehiscence after cesarean section. Fertil Steril. 2008 Apr;89(4):974-80. doi: 10.1016/j.fertnstert.2007.04.024. Epub 2007 Jul 10.
PubMed 17624346Bij de Vaate AJ, Brolmann HA, van der Voet LF, van der Slikke JW, Veersema S, Huirne JA. Ultrasound evaluation of the Cesarean scar: relation between a niche and postmenstrual spotting. Ultrasound Obstet Gynecol. 2011 Jan;37(1):93-9. doi: 10.1002/uog.8864.
PubMed 21031351
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04241107
- Acronym / sponsor ID
- isthmocele / Uterine niche repair
- Conditions
- Uterine Niche
- Keywords
- Cesarean Scar defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 27 Jan 2020 (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.
The treatment of uterine niche ranges from clinical management with expectant or pharmacological treatment, surgical treatment. Approaches for repair include Laparotomy, laparoscopy , hysteroscopy , vaginal. The decision to treat takes into consideration the size of the defect, presence of symptoms, secondary infertility and plans of pregnancy.
All of the approaches have its merits and debates. There is ongoing debate regarding the best surgical approach to managing this condition. To date no randomized controlled trials have been published to settle this debate.
Our study aim is to to evaluate which surgical approach is a preferable option, this study will be conducted to compare the Laparoscopic and transvaginal approaches in several regards, including, operation time, blood loss, perioperative complications, hospital stay length, postoperative increase in residual myometrial thickness during follow-up , clinical efficacy(percentage of patients who subject improvement of symptoms)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic approach group(A) | Active comparator | Procedure: Laparoscopic repair of Uterine nicheUterine niche will be repaired through Laparoscopic approach. |
| Transvaginal approach group(B) | Active comparator | Procedure: Transvaginal repair of Uterine nicheUterine niche will be repaired through Transvaginal approach. |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients who have uterine niche (defined as myometrial discontinuity or a hypoechoic triangle in the myometrium of the anterior uterine wall at the site of hysterotomy presented in transvaginal ultrasound or sonohysterography examination in non-pregnant women) ,with one or more previous caesarean section Who are:
- Symptomatic i.e patients having one or more of the following symptoms:
- Asymptomatic patients with one of the followings:
- the residual myometrial thickness over the niche less than 3 mm previous history of Cesarean Section scar ectopic pregnancy (not managed by resection and repair)
- who accept to participate the study.
Key exclusion criteria (10 listed)
- Asymptomatic patients with residual myometrial thickness more than 3 mm.
- No previous Cesarean section.
- If the patients symptoms presented before Cesarean section.
- Presence of other pathology that explain patient symptoms
- Presence of pathology that necessitate laparotomy.
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 |
|---|---|---|
| Laparoscopic repair of Uterine nicheRepair of uterine niche through Laparoscopic approach. | Procedure or surgery | Laparoscopic approach group(A) |
| Transvaginal repair of Uterine nicheRepair of uterine niche through Transvaginal approach. | Procedure or surgery | Transvaginal approach group(B) |
Primary outcome
Clinical efficacy
Time frame: 3 month postoperative
Number of patients who subject clinical improvement of pre-operative symptoms
Post-operative increase in residual myometrial thickness
Time frame: 3 month postoperative
difference between pre-operative \& post-operative residual myometrial thickness
3 secondary outcomes
Duration of operation
Time frame: baseline( During operation)
Blood loss
Time frame: baseline( During operation)
Intra-operative complication
Time frame: baseline( During operation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 26681211Betran AP, Torloni MR, Zhang JJ, Gulmezoglu AM; WHO Working Group on Caesarean Section. WHO Statement on Caesarean Section Rates. BJOG. 2016 Apr;123(5):667-70. doi: 10.1111/1471-0528.13526. Epub 2015 Jul 22. No abstract available.
- Background: PubMed 31703638Elnakib S, Abdel-Tawab N, Orbay D, Hassanein N. Medical and non-medical reasons for cesarean section delivery in Egypt: a hospital-based retrospective study. BMC Pregnancy Childbirth. 2019 Nov 8;19(1):411. doi: 10.1186/s12884-019-2558-2.
- Background: PubMed 23996650Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
- Background: PubMed 27393285Tulandi T, Cohen A. Emerging Manifestations of Cesarean Scar Defect in Reproductive-aged Women. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):893-902. doi: 10.1016/j.jmig.2016.06.020. Epub 2016 Jul 5.
- Background: PubMed 26409016Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.
- Background: PubMed 28598911Sipahi S, Sasaki K, Miller CE. The minimally invasive approach to the symptomatic isthmocele - what does the literature say? A step-by-step primer on laparoscopic isthmocele - excision and repair. Curr Opin Obstet Gynecol. 2017 Aug;29(4):257-265. doi: 10.1097/GCO.0000000000000380.
- Background: PubMed 24373597van der Voet LF, Bij de Vaate AM, Veersema S, Brolmann HA, Huirne JA. Long-term complications of caesarean section. The niche in the scar: a prospective cohort study on niche prevalence and its relation to abnormal uterine bleeding. BJOG. 2014 Jan;121(2):236-44. doi: 10.1111/1471-0528.12542.
- Background: PubMed 23680518Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
- Background: PubMed 23357466Marotta ML, Donnez J, Squifflet J, Jadoul P, Darii N, Donnez O. Laparoscopic repair of post-cesarean section uterine scar defects diagnosed in nonpregnant women. J Minim Invasive Gynecol. 2013 May-Jun;20(3):386-91. doi: 10.1016/j.jmig.2012.12.006. Epub 2013 Jan 26.
- Background: PubMed 28500899Abacjew-Chmylko A, Wydra DG, Olszewska H. Hysteroscopy in the treatment of uterine cesarean section scar diverticulum: A systematic review. Adv Med Sci. 2017 Sep;62(2):230-239. doi: 10.1016/j.advms.2017.01.004. Epub 2017 May 10.
- Background: PubMed 30039641Ludwin A, Martins WP, Ludwin I. Evaluation of uterine niche by three-dimensional sonohysterography and volumetric quantification: techniques and scoring classification system. Ultrasound Obstet Gynecol. 2019 Jan;53(1):139-143. doi: 10.1002/uog.19181. No abstract available.
- Background: PubMed 27473332Zhang X, Yang M, Wang Q, Chen J, Ding J, Hua K. Prospective evaluation of five methods used to treat cesarean scar defects. Int J Gynaecol Obstet. 2016 Sep;134(3):336-9. doi: 10.1016/j.ijgo.2016.04.011. Epub 2016 Jun 30.
- Various Types of Niche Imaging by SonohysterographyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud Abdel-Aleem, PhD study chair
Assiut University
Mahmoud zakhera, PhD study chair
Assiut University
Ahmed Abo El Fadle, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic repair of Uterine niche and Transvaginal repair of Uterine niche in people with Uterine Niche, run by Assiut 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 10 inclusion and 10 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 5 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdulrahman Muhammad Rageh, M.Sc (02 01005056259, Abdulrahmanrageh.26.9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy (time frame: 3 month postoperative). The study lists 2 primary outcomes in all. 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 NCT04241107, which also lists 14 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 5 Feb 2020.