A New Technique for Uterine Incision Closure at The Time of Cesarean Section: Does it Make a Difference

NCT04681378 | Completed DMC

• 1 other identifier: ID: 7-2016OBSGN17
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to compare the short term operative outcomes of three different surgical techniques for uterine incision closure during cesarean section (CS). This trial enrolled 120 patients scheduled for primary cesarean delivery. Patients were randomized into either classical double layer uterine closure, purse string double layer uterine closure (Turan), or our new approach of uterine closure (double layer step up-step down technique). For short term comparison, transvaginal ultrasonography was planned for all patients 6 weeks after surgery. Compared to group II and Group III, residual myometrial thickness was significantly thinner in group I (P\< 0.001). The number of patients with uterine niche was 10 (50% of all scar defects) in group I whereas it was 4 (20%) in group II and 6 (30%) in group III. Operative time was significantly longer in group II (P\< 0.001). This led to our conclusion that Turan technique and our new approach are associated with thicker myometrial thickness and less frequency of uterine scar defect than classical double layer uterine incision closure; however, our approach takes less operative time.

Conditions

Cesarean Section; Wound Dehiscence

Keywords

Cesarean Section; Uterine Incision Closure

Outcome Measures

Primary Outcomes (1)

• residual myometrial thickness

  The cesarean scar site was identified as a small triangular anechoic defect in the anterior wall of the uterus (uterine niche). In these patients RMT was measured from the top of niche to serosal surface. In patients without a scar defect RMT was measured from the delineation of the endometrium to the serosal surface at the level of CS scar and total myometrial thickness was measured at the myometrium adjacent to CS scar in all patients

  6 weeks after surgery

Study Arms (3)

Classical double layer closure

ACTIVE COMPARATOR

a holding Vicryl 1-0 was placed in the in the left corner to stabilize and define the demarcation of the suture line. A continuous unlocked stitch beginning at the right corner was used, closing the whole thickness of the uterine wall, including the decidual layer. The second unlocked stitch was performed by Vicryl 1-0 in a lateral -lateral (horizontal) position, adapting the first layer. Up to three additional single sutures were added for hemostasis if required.

Procedure: double layer step up-step down technique

Turan technique

ACTIVE COMPARATOR

beginning in one corner, the incision is closed using Vicryl 1-0 stitch. The first layer is transversely passed through the inner myometrium-decidua line, and second layer is transversely passed through outer myometrium-visceral line continuously in the form of a purse string closure. With this technique, the original string is returned to the starting point and tied with a knot. Following the double layered purse-string closure, the aperture left in the middle of the uterine incision is closed with one separate figure of eight suture

Procedure: double layer step up-step down technique

Double layer step up-step down technique

ACTIVE COMPARATOR

the incision is closed using Vicryl 1-0 stitch starting from one corner. The first layer is transversely passed through the inner myometrium-decidua line, and second layer is transversely passed through outer myometrium-visceral line continuously by alternating continuous stitches through the upper (step up) and the lower (step down) uterine flaps. The original string is returned to the starting point and tied with knot as in Turan technique. Following the double layered step up-step down closure, additional single sutures were added for hemostasis if required

Procedure: double layer step up-step down technique

Interventions

double layer step up-step down technique PROCEDURE

the incision is closed using Vicryl 1-0 stitch starting from one corner. The first layer is transversely passed through the inner myometrium-decidua line, and second layer is transversely passed through outer myometrium-visceral line continuously by alternating continuous stitches through the upper (step up) and the lower (step down) uterine flaps. The original string is returned to the starting point and tied with knot as in Turan technique. Following the double layered step up-step down closure, additional single sutures were added for hemostasis if required

Classical double layer closure; Double layer step up-step down technique; Turan technique

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women with a singleton prior cesarean section
• first-time cesarean delivery
• without preterm rupture of membranes, contractions or cervical dilatations

You may not qualify if:

• women under age of 18 years
• history of previous CS or any other uterine surgery
• placenta previa, abruptio placenta, fibroids located in the cervico-corporal border
• Maternal disease ( diabetes mellitus, anemia, connective tissue disorders, uterine malformations).

Sponsors & Collaborators

• Menoufia University: lead

Related Publications (1)

• Elkhouly NI, Abdelaal NK, Solyman AE, Elkelani OA, Elbasueny BF, Elhalaby AF. A new technique for uterine incision closure at the time of cesarean section: does it make a difference? J Obstet Gynaecol. 2022 Apr;42(3):416-423. doi: 10.1080/01443615.2021.1910636. Epub 2021 Jun 22.

  PMID: 34155957 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A computer-generated random numerical table (Randomization Generator Version 1.0) was used by our statistical department to prepare sealed opaque envelopes containing a group assignment. Three groups of envelopes-corresponding to the study groups were given to an anesthesia nurse. The nurse distributed envelopes to patients, alternating between groups during preanesthetic consultation. The patients were blinded the groups, and two authors performed the operations randomly. Another author who was blinded to the suturing technique performed all of the ultrasonographic examinations at 6 week follow up visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: This trial enrolled 120 patients scheduled for primary cesarean delivery. Patients were randomized into either classical double layer uterine closure, purse string double layer uterine closure (Turan), or our new approach of uterine closure (double layer step up-step down technique). For short term comparison, transvaginal ultrasonography was planned for all patients 6 weeks after surgery

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2020
• Last Updated: December 28, 2020

Record last verified: 2020-12