Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique

NCT ID: NCT02760290

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Fever Ileus Hemorrhage Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Extraperitoneal group

Extraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting.

Group Type EXPERIMENTAL

Extraperitoneal cesarean section

Intervention Type PROCEDURE

Intraperitoneal group

Conventional transperitoneal cesarean will perform

Group Type ACTIVE_COMPARATOR

Intraperitoneal cesarean section

Intervention Type PROCEDURE

Interventions

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Extraperitoneal cesarean section

Intervention Type PROCEDURE

Intraperitoneal cesarean section

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cesarean section for any reasons

Exclusion Criteria

* Involuntary
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Baki Senturk

Pirincipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Baki Şentürk, MD

Role: STUDY_DIRECTOR

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Locations

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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. Epub 2013 May 30.

Reference Type RESULT
PMID: 23727518 (View on PubMed)

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.

Reference Type RESULT
PMID: 18194912 (View on PubMed)

Related Links

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Other Identifiers

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56

Identifier Type: -

Identifier Source: org_study_id

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