Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06138938 |
| Other study ID # |
IstanbulMU-CananSATIROZEL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Istanbul Medeniyet University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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).
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.
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.
