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Cesarean SectionNCT06138938

Effects of Abdominal Irrigation During Cesarean

A study testing Intraoperative abdominal irrigation in people with Cesarean Section and Visual Analog Scale, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Cesarean Section, Visual Analog Scale
What is being tested?
Intraoperative abdominal irrigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2022to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • The inclusion criteria for the study were term (≥37 weeks) and singleton pregnancies that underwent elective CS (cesarean section) under general anesthesia.

Who cannot join

  • The exclusion criteria were as follows: local anesthesia during surgery, chronic diseases including gastrointestinal, neurologic, and endocrinologic pathologies, CS with emergency indications, maternal coagulopathy, chorioamnionitis, placenta previa, placenta accreta, and mental retardation.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Göztepe Prof Dr Süleyman Yalçın Şehir Hastanesi

    Istanbul, Kadıköy, 34722

Other trials in Turkey (Türkiye)

About this study

Official title: How Abdominal Irrigation During Cesarean Delivery Affects Gastrointestinal Functions and Short-term Maternal Morbidities: A Randomized Controlled Study

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.

Read the detailed description

This prospective randomized controlled clinical study was conducted between March 2022 and May 2022. Ethical committee approval was obtained from the Istanbul Medeniyet University Göztepe Training and Research Hospital (decision no: 2022/0139, date: 16.03.2022). Informed consent was taken from each patient. The inclusion criteria for the study were term (≥37 weeks) and singleton pregnancies that underwent elective CS (cesarean section) under general anesthesia. The exclusion criteria were as follows: local anesthesia during surgery, chronic diseases including gastrointestinal, neurologic, and endocrinologic pathologies, CS with emergency indications, maternal coagulopathy, chorioamnionitis, placenta previa, placenta accreta, and mental retardation. Elective CS was defined as CS performed before the presence of labor with or without previous CS history. Primary CS was used for women without an earlier CS history.

All participants completed a questionnaire regarding their parity, age, body mass index, comorbidities, current medication, and tobacco use. Then, the patients were randomized into the control and study groups. The study group was composed of patients indicated for abdominal irrigation during CS. A random number table was used to assign patients to either one of the groups. Patients' treatments are held in sequentially numbered secure, opaque envelopes. After routine abdominal cleaning, surgeons were informed by the operating nurse, who opened the envelope for each randomized patient before the operation. A Foley catheter was inserted into every patient before CS. Povidone-iodine solution was used for skin preparation. General anesthesia was used for all participants. Patients indicated for regional anesthesia were excluded because they may experience nausea, even perioperatively; therefore, an additional antiemetic drug can affect the results. The first author and her team (obstetrics and gynecology surgeons: C.S.O. and Z.R.G) performed all procedures. Following Pfannenstiel incision, fascial aponeurosis was separated from the rectus abdominis muscles in cranial and caudal directions. The rectus muscles were divided on the midline after the caudal-cut aponeurosis was elevated under tension. The peritoneum was opened in an identical manner using a vertical midline incision. A bladder flap was not a routine step otherwise, if not necessary. Kerr incision was created with a scalpel, followed by blunt expansion. After the umbilical cord clamping, the anesthetist administered a 10 IU intravenous bolus of oxytocin over 5-10 second to each patient. The placenta was delivered. A total of 3,000 mL of lactated Ringer solution containing 60 IU of oxytocin was administered for 24 hour. Antibiotic prophylaxis with 1 g cefazolin was administered routinely, and no additional drugs were used during the operation. After the exteriorization of the uterus, the hysterotomy incision was closed.

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.

The abdominal wall layers, including the peritoneum, were closed in every procedure. Subcutaneous tissue cauterization was performed to secure hemostasis. Moreover, 3-0 polyglactin 90 sutures were used to close the skin incision. Participants received the same postoperative care. Postoperative uterine contraction was checked every 15 minute for 2 hour and then every 4 hour. Urinary catheters were removed on the day after the operation. The physician staff responsible for collecting patients who reported nausea and vomiting symptoms was blinded to group randomization. Following 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. On postoperative day 1, patients' surgical incisions were examined. Requirements for antiemetic drugs and return of gastrointestinal function were recorded, and a complete blood count was ordered for each patient. The primary outcome measured was the time of the first passage of flatus. Return of bowel function was defined as the passage of flatus. Secondary outcome measures were the occurrence of postoperative infections, including endometritis. On bimanual examination, postpartum endometritis was described as a body temperature over 38.5 °C in addition to the presence of foul-smelling discharge or unusually tender uterus. The body temperature should be ≥38 °C for at least 24 h after surgery, described as febrile morbidity, which was not related to other indications of infection. Wound infection was defined as the partial or total separation of the incision presenting with a purulent or serous wound discharge with induration, warmth, and tenderness.

To calculate intraoperative blood loss, the volume in the suction apparatus and used swabs were measured. After translating swab weights into mL, using blood density (1,050 g/mL), the irrigation amount (1,000 mL) was subtracted from the calculated volume.

Another researcher (H.N.D), who was blinded to the group assignments, recorded and analyzed the data.

Being tested
Intraoperative abdominal irrigation
Keywords
Abdominal irrigation, Cesarean section, Emesis, Vomiting
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 groups in NCT06138938
Study groupRoleWhat they receive
Control GroupNo interventionIn the control group, abdominal irrigation as described in the study group was not performed.
Study GroupExperimentalAll 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.
Receives: Other: Intraoperative abdominal irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Gastrointestinal Functions

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

    Measured: 0-48 hour during postoperative follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Mar 2022
  3. Primary completion31 May 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06138938
Sponsor's protocol ID
IstanbulMU-CananSATIROZEL
Status last verified
Nov 2023
First submitted
15 Sep 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative abdominal irrigation in people with Cesarean Section and Visual Analog Scale, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: 0-1, 4-6, 10-12, and 22-24 hour during postoperative follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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