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NCT02760290 Clinical Trial

Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique

Pain Clinical Trial

Official title:
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique: Double Blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02760290
Other study ID # 56
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date July 2016

Study information
Verified date March 2022
Source Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.

Description:

Investigators will compared results intra and extraperitoneal cesarean section. Two groups will determine according to random numbers table. After operations, blood count, C reactive proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization time will compare by blind physician. Abdominal, shoulder and incisional pain at postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal results and complications also will compare. Investigators and participants will be blind regarding technique.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Cesarean section for any reasons Exclusion Criteria: - Involuntary

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Extraperitoneal cesarean section

• Intraperitoneal cesarean section

Locations
Country Name City State
Turkey Zeynep Kamil Maternity and Pediatric Research and Training Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Chou CY, Liang PC, Chen CA, Lee CN. Cervical abscess with vaginal fistula after extraperitoneal Cesarean section. J Formos Med Assoc. 2007 Dec;106(12):1048-51. doi: 10.1016/S0929-6646(08)60082-0. — View Citation

Tappauf C, Schest E, Reif P, Lang U, Tamussino K, Schoell W. Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity. Am J Obstet Gynecol. 2013 Oct;209(4):338.e1-8. doi: 10.1016/j.ajog.2013.05.057 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Scores as measured by the Visual Analog Scale 2 days
Secondary Blood count 2 days
Secondary C reactive proteins level 2 days
Secondary Complications 2 days
Secondary Discharge time 4 days
Secondary Forced expiratory volume in 1 second 2 days
Secondary Forced vital capacity 2 days
Secondary Peak expiratory flow 2 days
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