Intraoperative detection of c-section scar dehiscence with a light source

Pilot project of an intra-uterine manipulator with integrated, scalable light source with image processing system for correction of uterine scar dehiscence (niche)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60638492

Enrollment

Registered

2024-09-10

Start date

2025-02-01

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with a isthmocele (c-section scar dehiscence) Pregnancy and Childbirth

Interventions

Due to the increasing rates of caesarean sections, there is a growing prevalence of uterine scar dehiscence (niche) and subsequent niche repair. Women with a niche and a thinner remaining uterine wall

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patients with uterine scar dehiscence (niche) who need a laparoscopic repair (remaining uterine wall <3mm) 2. Signed general consent/informed consent 3. Patients =18 years

Exclusion criteria

Exclusion criteria: 1. Missing signed general consent/informed consent 2. Contraindications to general anaesthesia 3. Not knowledgeable in the German language

Design outcomes

Primary

Measure	Time frame
Measured at the time of the procedure: 1. Light detection through the niche (yes/no) 2. Light intensity intraabdominal. The SI unit of light intensity is lumen by steradian (lm/sr) measured as candela (cd) (1 cd = 1 lm/sr) 3. Light intensity through the niche in comparison to the surrounding intraabdominal light intensity (measured in %)	—

Secondary

Measure	Time frame
Measured at the time of the procedure, unless noted otherwise: 1. Time for installation of the SLS (min) 2. Surgery time from the start of laparoscopy to detection of the niche (min) 3. Surgery time from detection of the niche to excision (min) 4. Surgery time from excision to the closure of the niche (3-layered suture) - complete surgery time (min) 5. Blood loss during surgery (ml) 6. Thickness of the niche tissue intraoperatively compared with the preoperatively measured sonographic thickness of the residual myometrium over the niche (mm) 7. Perioperative and postoperative complications (Clavien-Dindo classification) at time of operation and 6 weeks follow up 8. Subjective characteristics such as surgeon satisfaction and difficulty of the procedure measured using a Likert scale after the procedure 9. Safety outcomes measured using patient records	—

Measure

Time frame

Measured at the time of the procedure, unless noted otherwise: 1. Time for installation of the SLS (min) 2. Surgery time from the start of laparoscopy to detection of the niche (min) 3. Surgery time from detection of the niche to excision (min) 4. Surgery time from excision to the closure of the niche (3-layered suture) - complete surgery time (min) 5. Blood loss during surgery (ml) 6. Thickness of the niche tissue intraoperatively compared with the preoperatively measured sonographic thickness of the residual myometrium over the niche (mm) 7. Perioperative and postoperative complications (Clavien-Dindo classification) at time of operation and 6 weeks follow up 8. Subjective characteristics such as surgeon satisfaction and difficulty of the procedure measured using a Likert scale after the procedure 9. Safety outcomes measured using patient records

—

Countries

Switzerland

Contacts

Public ContactCornelia Betschart

cornelia.betschart@usz.ch+41 44 255 52 03

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026