Viewing Study NCT06113718


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Study NCT ID: NCT06113718
Status: COMPLETED
Last Update Posted: 2023-11-02
First Post: 2023-10-17
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies
Sponsor: Tepecik Training and Research Hospital
Organization:

Study Overview

Official Title: The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies
Status: COMPLETED
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IPBEPOBF
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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: