Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
Study Details
Study Description
Brief Summary
In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.
In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: New Closure Technique This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique. |
Procedure: Niche prevention suture
This group will have the uterus sutured in two layers using a new technique.
|
| No Intervention: Regular closure technique The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture. |
Outcome Measures
Primary Outcome Measures
- Formation of a uterine niche [At least 12 weeks after delivery.]
Presence of a uterine niche on ultrasound
Secondary Outcome Measures
- Duration of surgery [At surgery]
Total duration of surgery
- Blood loss over 1000 mL [At surgery]
As assessed by the operating surgeon
- Postoperative infection [Up to 6 weeks after intervention]
The number of patients who are diagnosed with postoperative infection including endometritis or wound infection.
- Need for repeat laparotomy [Up to 6 weeks after intervention]
The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained.
- Formation of a n abscess/hematoma [Up to 6 weeks after intervention]
The number of patients who are diagnosed with a pelvic abscess or hematoma from the time of the cesarean delivery until 6 weeks after the cesarean delivery.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women at first cesarean delivery
-
Women who consent to the study
Exclusion Criteria:
-
Women who are having a repeat caesarean section
-
Refusal to participate in the study
-
Urgent or emergent cesarean delivery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hadassah Medical Organization | Jerusalem | Israel |
Sponsors and Collaborators
- Hadassah Medical Organization
Investigators
- Principal Investigator: Hila Hochler, MD, Hadassah Medical Organization
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8978006-HMO-CTIL