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

NCT06113718 | Completed

• 1 other identifier: TTRH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paralytic Ileus; Nausea; Defecation Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Postoperative gastrointestinal symptoms

  postoperative period, an average of 15 days

Study Arms (2)

Exercise Group

EXPERIMENTAL

Group that performed abdominal exercise for 1 week before operation.

Procedure: Abdominal Exercise (digital rectal stimulation, abdominal massage)

Control Group

NO INTERVENTION

Group without preoperative abdominal exercise.

Interventions

Abdominal Exercise (digital rectal stimulation, abdominal massage) PROCEDURE

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study was conducted in patients undergoing gynecologic oncology surgery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Training and Research Hospital

Izmir, Konak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction; Nausea

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muzaffer Sancı

  Tepecik Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncology Fellow

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 2, 2023
• Study Start: January 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: September 15, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)