Clinical trial NCT06113718: The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies
Official title: The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paralytic Ileus
Nausea
Defecation Disorder
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: First exhaust and defecation time
timeFrame: postoperative period, an average of 15 days
measure: Bowel Sounds
timeFrame: postoperative period, an average of 15 days
measure: Solid food tolerance
timeFrame: postoperative period, an average of 15 days
measure: Length of hospital
timeFrame: postoperative period, an average of 15 days
Secondary outcomes:
measure: Postoperative gastrointestinal symptoms
timeFrame: postoperative period, an average of 15 days
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Training and Research Hospital
state: Konak
Study officials:
affiliation: Tepecik Training and Research Hospital
name: Muzaffer Sancı
role: STUDY_DIRECTOR
References: