Effects of Abdominal Irrigation During Cesarean

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Visual Analog Scale
• Intervention / Treatment: Other: Intraoperative abdominal irrigation

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kadıköy
    • Istanbul, Kadıköy, Turkey, 34722
      • Göztepe Prof Dr Süleyman Yalçın Şehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; In the control group, abdominal irrigation as described in the study group was not performed.
Experimental: Study Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Principal Investigator: Oguz Devrim Yardimci, Goztepe Prof Dr Suleyman Yalcin City Hospital; Study Chair: Abdulkadir Turgut, Istanbul Medeniyet University; Principal Investigator: Nisan Helin Donmez, Goztepe Prof Dr Suleyman Yalcin City Hospital; Principal Investigator: Zelal Rojda Gungordu, Goztepe Prof Dr Suleyman Yalcin City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Estimated): November 20, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Vomiting; Cesarean section; Emesis; Abdominal irrigation
• Other Study ID Numbers: IstanbulMU-CananSATIROZEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No