Isthmocele
Conditions
Keywords
isthmocele, laparoscopy, postmenstrual bleeding, V-LocTM 180, Polyglactin 910
Brief summary
To evaluate postoperative outcomes in patients with isthmocele undergoing laparoscopic repair, comparing the efficacy of V-LocTM 180 and Polyglactin 910 Vicryl sutures. Patients were randomized to undergo laparoscopic isthmocele repair using one of the following suture materials: (1) V-LocTM 180 or (2) Polyglactin 910 Vicryl.
Detailed description
The global rise in cesarean section (CS) rates has led to an increased incidence of associated complications, presenting new challenges in gynecological practice. One of these complications is a cesarean scar defect, also known as isthmocele, which manifests as a pouch-like structure at the site of the previous CS scar. This defect often results in the accumulation of menstrual blood, inflammatory cells, and mucus, leading to symptoms such as postmenstrual bleeding, pelvic pain, and dyspareunia. Furthermore, isthmocele has been implicated in secondary infertility due to the inflammatory changes it induces in the endometrium. Additionally, the presence of an isthmocele increases the risk of complications in future pregnancies, including cesarean scar ectopic pregnancy, uterine rupture, and placenta accreta spectrum disorders. Diagnosis of isthmocele relies on imaging modalities such as transvaginal ultrasound (TVUS), sonohysterography (SHG), or hysteroscopy. While asymptomatic cases generally do not require intervention, symptomatic patients may benefit from medical or surgical treatment. Due to limited evidence supporting medical therapy, surgical intervention has become the preferred approach, particularly for patients desiring future fertility. Various surgical techniques, including hysteroscopic, laparoscopic, vaginal, laparotomic, and combined procedures, have been proposed for isthmocele repair. Among these, laparoscopic isthmocele repair is favored for patients with fertility concerns as it enables complete excision of the defective myometrial tissue and reconstruction of the uterine wall. Despite the advantages of laparoscopic isthmocele repair, no universally accepted cutoff value for residual myometrial thickness dictates surgical candidacy. Previous studies have suggested that laparoscopic repair is a safer and more practical option for cases with significant myometrial loss (\>80%). However, there is limited data on the impact of different suture materials used in laparoscopic repair on postoperative outcomes.
Interventions
PROCEDURELaparoscopic isthmocele repair using V-LocTM 180 barbed suture
The standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark.
OTHERLaparoscopic isthmocele repair using Polyglactin 910 vicryl suture
The standardized surgical steps for the laparoscopic isthmocele repair were as follows; 1) A 30-degree telescope was introduced through a 10 mm trocar at the umbilicus following the establishment of pneumoperitoneum. 2) Three 5 mm trocars were inserted: two in the bilateral lower quadrants and one in the suprapubic region. 3) The bladder was distended with 300 cc of saline infusion to facilitate dissection of the vesicovaginal space and to allow inferior mobilization of the bladder, thereby ensuring optimal visualization of the isthmocele region. Dissection was performed laterally up to the level of the uterine arteries, thereby minimizing the risk of vascular injury. 4) The light source of the laparoscope was deactivated, enabling the identification of the isthmocele region by utilizing the illumination provided by the hysteroscope. 5) Excision of the abnormal tissue was carried out using an ultrasonic energy device (HARMONIC®), guided by the manipulator shaft as a landmark.
Sponsors
Kanuni Sultan Suleyman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* The study will include women aged 18-45 years who present with symptomatic isthmocele. * Participants must have a residual myometrial thickness of less than 2.5 mm. * Participants must desire future fertility.
Exclusion criteria
Age below 18 or above 45 years Atypical endometrial cells or cervical dysplasia on cytology Asymptomatic isthmocele Candidacy for hysteroscopic surgery Cervical or pelvic infections Cervical dilation of 4 cm or more (emergency surgery) Conditions impairing tissue healing, such as: Type 1 or Type 2 diabetes mellitus Hematologic disorders associated with bleeding diathesis Contraindications for spinal or general anesthesia Continuous use of oral contraceptives (OCPs) or GnRH agonists that affect menstrual cycles Hydrosalpinx communicating with the uterine cavity Intrauterine device (IUD) in place Known connective tissue disorders Menstrual irregularities: Cycles longer than 35 days Cycle variations of 2 weeks or more Ongoing pregnancy Presence of structural abnormalities such as: Uterine or cervical polyps Submucosal fibroids Other similar conditions Residual myometrial thickness \> 2.5 mm Retained placental tissue Suspected malignancies Uterine anomalies Immunosuppressive diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative residual myometrial thickness | 1 year | Ultrasonographic evaluation will be performed in the 12th postoperative month to measure residual myometrial thickness and assess the anatomical success of the repair. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction and quality of life | 1 year | Participants will complete the Female Sexual Function Index (FSFI) questionnaire in the postoperative 12th month to evaluate sexual function and overall health-related quality of life. |
| 3.Patient satisfaction | 1 year | Participants will complete the SF-36 questionnaire in the postoperative 12th month to evaluate sexual function and overall health-related quality of life. |
Countries
Turkey (Türkiye)
Outcome results
None listed