Laparoscopic Isthmocele Repair
Efficacy and Safety of V-LocTM 180 Barbed Sutures Compared to Polyglactin 910 Vicryl in Laparoscopic Isthmocele Repair: A Prospective Randomized Study
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İstanbul, Turkey, 34480
- Başakşehir Çam and Sakura City Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: laparoscopic isthmocele repair using V-LocTM 180 barbed suture
The isthmocele area will be sutured using V-LocTM 180 barbed suture in a continuous, non-locked fashion.
The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges.
|
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.
|
|
Active Comparator: laparoscopic isthmocele repair using Polyglactin 910 Vicryl sutures
The isthmocele area will be sutured using Polyglactin 910 Vicryl sutures in a continuous, non-locked fashion.
The repair was performed using a two-layer closure technique, ensuring precise reapproximation of the myometrial edges without breaching the uterine cavity, followed by closure of the serosal edges.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative residual myometrial thickness
Time Frame: 1 year
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Ultrasonographic evaluation will be performed in the 12th postoperative month to measure residual myometrial thickness and assess the anatomical success of the repair.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction and quality of life
Time Frame: 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.
|
1 year
|
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3.Patient satisfaction
Time Frame: 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.
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CSCHospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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