Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06113718
Other study ID # TTRH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date September 15, 2023

Study information

Verified date October 2023
Source Tepecik Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 15, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Tepecik Training and Research Hospital Izmir Konak

Sponsors (1)

Lead Sponsor Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Length of hospital Duration of postoperative hospitalization. postoperative period, an average of 15 days
Secondary Postoperative gastrointestinal symptoms Abdominal pain, abdominal distension and nausea/vomiting. postoperative period, an average of 15 days
See also
  Status Clinical Trial Phase
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy Phase 1
Completed NCT02939287 - Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan Phase 3
Not yet recruiting NCT06464926 - Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE) N/A
Not yet recruiting NCT06055192 - Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT02462811 - A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV) Phase 3
Completed NCT01007500 - Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery Phase 4
Recruiting NCT00528554 - Laser Acupuncture Against Nausea in Children N/A
Completed NCT00537875 - Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens N/A
Completed NCT00394966 - A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED) Phase 2
Completed NCT00946387 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions Phase 1
Completed NCT00947128 - To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions Phase 1
Recruiting NCT05433636 - Mindful Waiting Room N/A
Not yet recruiting NCT04827108 - Psychometric Properties of the Chinese Version of PeNAT
Not yet recruiting NCT04853303 - VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK N/A
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Recruiting NCT04181346 - Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting Phase 2
Recruiting NCT03679182 - Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care Phase 2
Completed NCT02618343 - EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron N/A
Terminated NCT01405924 - Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030) Phase 2