The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies (IPBEPOBF)

Gastrointestinal dysfunction is a common complication after abdominal gynecologic oncology surgery. There are numerous studies in the literature addressing the management of bowel function in the postoperative period. Unfortunately, the strategies in the literature are not one hundred percent successful, and complete prevention of postoperative bowel dysfunction cannot be achieved. There is no study in the literature demonstrating that abdominal exercises given to patients undergoing surgery for gynecological malignancies in the preoperative period improve gastrointestinal function in the postoperative period.

The aim of this study is to evaluate the effect of an exercise plan, including abdominal massage and rectal digital stimulation, performed before gynecologic oncology surgery on postoperative bowel functions.

Study Overview

• Status: Completed
• Conditions: Nausea; Defecation Disorder; Paralytic Ileus
• Intervention / Treatment: Procedure: Abdominal Exercise (digital rectal stimulation, abdominal massage)

Detailed Description

This randomized study was approved by the Tepecik Training and Research Hospital Ethics Committee and conducted between January 1, 2023, and August 31, 2023. Patients diagnosed with gynecologic malignancies at our center were included in the study. Patients in the study group were provided with abdominal exercises one week before surgery, and they practiced exercises that included abdominal massage and rectal digital stimulation during the week leading up to the operation. Patients who did not perform exercises were included as the control group.

Participants were randomized after obtaining written informed consent forms. Patients with an operation plan were assigned to one of the two groups through randomization by the principal investigator. Group 1 patients constituted the control group, while Group 2 consisted of patients who regularly performed the recommended bowel exercise program every morning one week before the surgery. The recommended bowel exercise program was explained in detail to patients by the responsible researcher on the day of their preoperative anesthesia preparations (at least 10 days before the surgery) in the pre-op preparation room, accompanied by visual presentations. The recommended bowel exercise program consisted of three steps:

1. Patients will perform a 2-3 minute massage starting from the cecum approximately 20-30 minutes after breakfast, moving along the colon.
2. Patients will assume a suitable position and perform circular massage on the anal walls with their finger for approximately 30 seconds (digital rectal stimulation).
3. Patients will try to defecate while sitting on the toilet.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konak
    • İzmir, Konak, Turkey
      • Tepecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients who underwent surgery for endometrium, cervical and ovarian cancer indications,
• Patients with American Society of Anesthesiologists (ASA) score 1 or 2

Exclusion Criteria:

• Patients with American Society of Anesthesiologists (ASA) score 3 or 4
• Those with inflammatory bowel disease,
• Those who have abdominal fluid severe enough to prevent exercise,
• Patients with liver, kidney and thyroid function disorders,
• Patients with orthopedic problems affecting mobility,
• Patients with a history of abdominal bowel surgery,
• Those who received abdominal radiotherapy, hyperthermic intraperitoneal chemotherapy or neoadjuvant chemotherapy,
• Patients who had bowel injuries during surgery, bowel resection, anastomosis or colostomy,
• Patients who underwent Hipec,
• Patients who underwent relaparotomy before discharge due to reasons such as bleeding or evisceration

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; Group that performed abdominal exercise for 1 week before operation.	Procedure: Abdominal Exercise (digital rectal stimulation, abdominal massage); The recommended bowel exercise program consisted of three steps: Patients will perform a 2-3 minute massage starting from the cecum approximately 20-30 minutes after breakfast, moving along the colon.; Patients will assume a suitable position and perform circular massage on the anal walls with their finger for approximately 30 seconds (digital rectal stimulation).; Patients will try to defecate while sitting on the toilet.
No Intervention: Control Group; Group without preoperative abdominal exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First exhaust and defecation time	Postoperative time to first exhaust and defecation refers to the time elapsed from the end of the surgery to the first occurrence of gas and defecation.	postoperative period, an average of 15 days
Bowel Sounds	Time to the return of bowel sounds is determined by researchers listening to bowel sounds with a stethoscope every 4 hours starting 8 hours after the surgery. It is based on the time when the first occurrence of 3-5 bowel sounds per minute is detected.	postoperative period, an average of 15 days
Solid food tolerance	Duration of solid food tolerance is recorded as the time during which the patient can tolerate any food that requires chewing after surgery, without experiencing symptoms such as nausea or vomiting within 2 hours of consumption.	postoperative period, an average of 15 days
Length of hospital	Duration of postoperative hospitalization.	postoperative period, an average of 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative gastrointestinal symptoms	Abdominal pain, abdominal distension and nausea/vomiting.	postoperative period, an average of 15 days

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital
• Investigators: Study Director: Muzaffer Sancı, Tepecik Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Intestinal Pseudo-Obstruction
• Other Study ID Numbers: TTRH

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