Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial

Uterine Niche Clinical Trial

— isthmocele  

Official title:

Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04241107
• Other study ID #: Uterine niche repair
• Status: Recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: March 2022

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: Abdulrahman Muhammad Rageh, M.Sc
• Phone: 02 01005056259
• Email: Abdulrahmanrageh.26.9[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

Inclusion Criteria:

• 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:

1. Symptomatic i.e patients having one or more of the following symptoms:

1. 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]),

2. Secondary Dysmenorrhea( defined as the pain or discomfort associated with menstruation)

3. deep dyspareunia(deep genital pain associated with sexual intercourse)

4. 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.

5. 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.)

2. 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)

3. who accept to participate the study.

Exclusion Criteria:

1. Asymptomatic patients with residual myometrial thickness more than 3 mm.

2. No previous Cesarean section.

3. If the patients symptoms presented before Cesarean section.

4. Presence of other pathology that explain patient symptoms

1. sub mucous fibroid

2. cervical-Endometrial carcinoma

3. Endometrial hyperplasia

4. Coagulation defect.

5. Presence of pathology that necessitate laparotomy.

6. Patient who refuse to participate the study.

Related Conditions & MeSH terms

• Uterine Niche

Intervention

Procedure:
• Laparoscopic repair of Uterine niche
Repair of uterine niche through Laparoscopic approach.
• Transvaginal repair of Uterine niche
Repair of uterine niche through Transvaginal approach.

Locations

Country	Name	City	State
Egypt	Abdulrahman Muhammad Rageh	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

Abacjew-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. Review. — View Citation

Betran AP, Torloni MR, Zhang JJ, Gülmezoglu 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. — View Citation

Bij de Vaate AJ, Brölmann 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. — View Citation

Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brölmann 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. Review. — View Citation

Donnez 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. Epub 2007 Jul 10. — View Citation

Elnakib 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. — View Citation

Ludwin 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. — View Citation

Marotta 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. — View Citation

Sipahi 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. Review. — View Citation

Tower 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. Review. — View Citation

Tulandi 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. Review. — View Citation

van der Voet LF, Bij de Vaate AM, Veersema S, Brölmann 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. — View Citation

Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brölmann 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. — View Citation

Zhang 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy	Number of patients who subject clinical improvement of pre-operative symptoms	3 month postoperative
Primary	Post-operative increase in residual myometrial thickness	difference between pre-operative & post-operative residual myometrial thickness	3 month postoperative
Secondary	Duration of operation	duration from anesthesia till end of operation	baseline( During operation)
Secondary	Blood loss	estimated blood loss during operation(towels , suction container)	baseline( During operation)
Secondary	Intra-operative complication	complication during the operation	baseline( During operation)

External Links

•   Various Types of Niche Imaging by Sonohysterography