NCT06138938

Brief Summary

This prospective randomized controlled clinical trial was conducted between March 2022 and May 2022 and included 60 patients who underwent elective cesarean. The participants were randomized into two groups: abdominal irrigation (n=30) and control group (n=30). Participants undergo a standard cesarean procedure, and general anesthesia was preferred. The patients were questioned regarding nausea, vomiting, highest pain scores, time of flatus, and stool passage during the postoperative period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

September 15, 2023

Last Update Submit

November 17, 2023

Conditions

Cesarean SectionVisual Analog Scale

Keywords

Abdominal irrigationCesarean sectionEmesisVomiting

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    The visual analog scale (VAS) explanation to all participants, the highest pain scores at 0-1, 4-6, 10-12, and 22-24 hour during postoperative follow-up were noted.

    0-1, 4-6, 10-12, and 22-24 hour during postoperative follow-up

  • Gastrointestinal Functions

    Time for passage of flatus (Return of bowel function was defined as the passage of flatus).

    0-48 hour during postoperative follow-up

Study Arms (2)

Control Group

NO INTERVENTION

In the control group, abdominal irrigation as described in the study group was not performed.

Study Group

EXPERIMENTAL

All blood clots and other remnants were manually externalized with a sponge holder forceps from the pelvic areas following the uterine incision closure. Then, 1,000 mL of warm saline irrigation was poured into the vesicouterine cavity and aspirated as much as possible in the reverse Trendelenburg position using an aspirator, carefully avoiding any contact with the intestines.

Other: Intraoperative abdominal irrigation

Interventions

Intraoperative abdominal irrigationOTHER

All blood clots and other remnants were manually externalized with a sponge holder forceps from the pelvic areas following the uterine incision closure. Then, 1,000 mL of warm saline irrigation was poured into the vesicouterine cavity and aspirated as much as possible in the reverse Trendelenburg position using an aspirator, carefully avoiding any contact with the intestines.

Study Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göztepe Prof Dr Süleyman Yalçın Şehir Hastanesi

Istanbul, Kadıköy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oguz Devrim Yardimci

    Goztepe Prof Dr Süleyman Yalcin City Hospital

    PRINCIPAL INVESTIGATOR

  • Abdulkadir Turgut

    Istanbul Medeniyet University

    STUDY CHAIR

  • Nisan Helin Donmez

    Goztepe Prof Dr Süleyman Yalcin City Hospital

    PRINCIPAL INVESTIGATOR

  • Zelal Rojda Gungordu

    Goztepe Prof Dr Süleyman Yalcin City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Gynecology and Obstetrics Specialist

Study Record Dates

First Submitted

September 15, 2023

First Posted

November 18, 2023

Study Start

March 1, 2022

Primary Completion

May 31, 2022

Study Completion

June 30, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)