Paralytic IleusIPBEPOBFNCT06113718
The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies
A study testing Abdominal Exercise (digital rectal stimulation, abdominal massage) in people with Paralytic Ileus and Nausea, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Paralytic Ileus, Nausea, Defecation Disorder
- What is being tested?
- Abdominal Exercise (digital rectal stimulation, abdominal massage)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who underwent surgery for endometrium, cervical and ovarian cancer indications,
- Patients with American Society of Anesthesiologists (ASA) score 1 or 2
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Training and Research Hospital
Izmir, Konak
About this study
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.
Read the 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:
- 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.
- Conditions
- Paralytic Ileus, Nausea, Defecation Disorder
- Being tested
- Abdominal Exercise (digital rectal stimulation, abdominal massage)
- Medical subject headings
- Intestinal Pseudo-Obstruction, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Exercise (digital rectal stimulation, abdominal massage)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Group that performed abdominal exercise for 1 week before operation. Receives: Procedure: Abdominal Exercise (digital rectal stimulation, abdominal massage) |
| Control Group | No intervention | Group without preoperative abdominal exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: postoperative period, an average of 15 days
Length of hospital
Duration of postoperative hospitalization.
Measured: postoperative period, an average of 15 days
Secondary outcomes (1)
Postoperative gastrointestinal symptoms
Abdominal pain, abdominal distension and nausea/vomiting.
Measured: postoperative period, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2023
- Primary completion31 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralytic IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celal Akdemir, Tepecik Training and Research Hospital
- Investigators
- Muzaffer Sancı, Study director, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113718
- Sponsor's protocol ID
- TTRH
- Acronym
- IPBEPOBF
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Bowel Exercise on Postoperative Bowel Functions in Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT06113718
- Acronym / sponsor ID
- IPBEPOBF / TTRH
- Conditions
- Paralytic Ileus, Nausea, Defecation Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Procedure: Abdominal Exercise (digital rectal stimulation, abdominal massage)Group that performed abdominal exercise for 1 week before operation. |
| Control Group | No intervention | –Group without preoperative abdominal exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent surgery for endometrium, cervical and ovarian cancer indications,
- Patients with American Society of Anesthesiologists (ASA) score 1 or 2
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Exercise (digital rectal stimulation, abdominal massage)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. | Procedure or surgery | Exercise Group |
Primary outcome
First exhaust and defecation time
Time frame: postoperative period, an average of 15 days
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.
Bowel Sounds
Time frame: postoperative period, an average of 15 days
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.
Solid food tolerance
Time frame: postoperative period, an average of 15 days
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.
Length of hospital
Time frame: postoperative period, an average of 15 days
Duration of postoperative hospitalization.
1 secondary outcome
Postoperative gastrointestinal symptoms
Time frame: postoperative period, an average of 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muzaffer Sancı study director
Tepecik Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Exercise (digital rectal stimulation, abdominal massage) in people with Paralytic Ileus and Nausea, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First exhaust and defecation time (time frame: postoperative period, an average of 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.