Endometrial CancerNCT07702799
Low-Residue Diet Versus Rectal Enema Before Laparoscopic Surgery for Endometrial Cancer
A study testing Low-Residue Diet and Sodium Phosphate Rectal Enema in people with Endometrial Cancer, run by Mahmut Yassa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Low-Residue Diet and Sodium Phosphate Rectal Enema
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 to 90 years.
- Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
- Willing and able to provide written informed consent.
Who cannot join
- Planned open (abdominal) surgery.
- Known allergy or contraindication to sodium phosphate rectal enema.
- Age over 90 years.
- Refusal or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Istanbul
mahmut yassa, +905396635484, mahmut_yassa@hotmail.com
Bora Taşpınar, MD
About this study
Official title: Low-Residue Diet Versus Rectal Enema Before Laparoscopic Endometrial Cancer Surgery: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view during surgery.
The main questions it aims to answer are:
Read more
- Can the dietary bowel preparation protocol provide surgical exposure comparable to a rectal enema?
- Can the dietary bowel preparation protocol reduce the minimum Trendelenburg position and pneumoperitoneum pressure required to obtain an adequate surgical view?
- Does either bowel preparation method cause more discomfort or side effects before surgery?
Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery.
Participants will:
- Be randomly assigned to receive either a standardized 3-day bowel preparation protocol or a rectal enema before surgery.
- Undergo standard laparoscopic surgery for endometrial cancer.
- Have surgical exposure, the minimum Trendelenburg position, the minimum pneumoperitoneum pressure, operative outcomes, postoperative recovery, and bowel preparation-related symptoms and discomfort assessed as part of routine clinical care.
Read the detailed description
Adequate bowel preparation is important for achieving optimal surgical exposure during laparoscopic surgery for endometrial cancer. Inadequate bowel preparation may impair visualization of the operative field, requiring steeper Trendelenburg positioning and higher pneumoperitoneum pressures, which may increase the physiological burden of surgery and affect operative performance.
Mechanical bowel preparation with rectal enema is commonly used before gynecologic surgery, although its routine use remains controversial because evidence supporting its clinical benefit is limited. A standardized 3-day bowel preparation protocol may improve patient tolerance while maintaining adequate surgical conditions. However, prospective randomized studies comparing these two approaches specifically in laparoscopic endometrial cancer surgery remain limited.
This prospective randomized controlled trial will compare a standardized 3-day bowel preparation protocol with a preoperative rectal enema before laparoscopic surgery for endometrial cancer. The primary objective is to determine whether the dietary bowel preparation protocol can provide surgical conditions comparable to those achieved with rectal enema.
In addition to subjective assessment of surgical exposure, the study will evaluate objective intraoperative parameters, including the minimum Trendelenburg position and the minimum pneumoperitoneum pressure required to maintain an adequate surgical view. Operative outcomes, postoperative recovery, patient tolerance of the bowel preparation methods, and bowel preparation-related symptoms will also be evaluated.
The findings of this study may help optimize preoperative bowel preparation strategies, reduce unnecessary patient burden, and support evidence-based perioperative care for patients undergoing laparoscopic surgery for endometrial cancer.
- Conditions
- Endometrial Cancer
- Being tested
- Low-Residue Diet, Sodium Phosphate Rectal Enema
- Keywords
- endometrial cancer, Laparoscopic Surgery, Bowel Preparation, Low-Residue Diet, Rectal Enema, Surgical Exposure, Trendelenburg Position, Pneumoperitoneum, Gynecologic Oncology
- Medical subject headings
- Endometrial Neoplasms, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Residue DietBehavioural
Participants will follow a standardized 3-day bowel preparation protocol consisting of a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery, with adequate hydration throughout the preparation period.
Sodium Phosphate Rectal EnemaDrug
Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the manufacturer's instructions and the institutional bowel preparation protocol.
| Study group | Role | What they receive |
|---|---|---|
| Low-Residue Diet | Experimental | Participants will follow a standardized 3-day bowel preparation protocol before surgery. The protocol includes a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery Receives: Behavioral: Low-Residue Diet |
| Rectal Enema | Active comparator | Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the institutional bowel preparation protocol Receives: Drug: Sodium Phosphate Rectal Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Visual Index Score
Surgical exposure will be assessed intraoperatively using the Visual Index score after establishment of pneumoperitoneum and placement of the camera trocar and one lateral ancillary trocar. The score ranges from 0 to 2, where 0 indicates inadequate visualization despite bowel retraction with one grasper, 1 indicates adequate visualization requiring bowel retraction with one grasper, and 2 indicates adequate visualization without bowel retraction. Higher scores indicate better surgical exposure.
Measured: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar
Minimum Trendelenburg Position Required for Adequate Surgical Exposure
The minimum Trendelenburg angle (degrees) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Measured: Intraoperatively
Minimum Pneumoperitoneum Pressure Required for Adequate Surgical Exposure
The minimum pneumoperitoneum pressure (mmHg) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Measured: Intraoperatively
Secondary outcomes (4)
Operative Time
Total operative time measured from skin incision to skin closure, recorded in minutes.
Measured: During surgery
Length of Hospital Stay
Length of postoperative hospital stay, measured in days from surgery until hospital discharge.
Measured: At hospital discharge, assessed up to 30 days after surgery
Time to First Flatus
Time from completion of surgery to the first documented passage of flatus, measured in hours. The occurrence and timing of first flatus will be assessed during daily postoperative visits until the event occurs or until hospital discharge.
Measured: From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days
Patient Tolerance of Bowel Preparation
Patient tolerance will be assessed using completion of the assigned bowel preparation protocol, willingness to repeat the same preparation method in a future surgery, postoperative pain score, and bowel preparation-related symptoms. Symptoms will include nausea, overall discomfort, headache, insomnia, thirst, abdominal cramps, weakness, and fatigue, each assessed using a 0-10 numeric rating scale, where 0 indicates no symptom and 10 indicates the worst possible symptom.
Measured: From preoperative bowel preparation until postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jul 2026
- Primary completion15 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either a low-residue diet or a rectal enema before surgery. Group allocation will be performed using a computer-generated randomization list with sequentially numbered opaque envelopes. Operating surgeons assessing the intraoperative primary outcomes will remain unaware of treatment allocation until completion of the intraoperative assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmut Yassa
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mahmut Yassa, Başakşehir Çam & Sakura City Hospital
- Investigators
- Mahmut Yassa, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702799
- Sponsor's protocol ID
- ENDO-DIET-RCT-2026
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, together with a data dictionary, will be made available upon reasonable request to the corresponding investigator. Data will be shared only after publication of the primary study results and subject to institutional approval, a scientifically sound research proposal, and execution of a data use agreement. Additional data may be considered on a case-by-case basis at the discretion of the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Residue Diet Versus Rectal Enema Before Laparoscopic Endometrial Cancer Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07702799
- Acronym / sponsor ID
- ENDO-DIET-RCT-2026
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, Laparoscopic Surgery, Bowel Preparation, Low-Residue Diet, Rectal Enema, Surgical Exposure, Trendelenburg Position, Pneumoperitoneum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahmut YassaOther government
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 14 Jul 2026 (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.
The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view during surgery.
The main questions it aims to answer are:
- Can the dietary bowel preparation protocol provide surgical exposure comparable to a rectal enema?
- Can the dietary bowel preparation protocol reduce the minimum Trendelenburg position and pneumoperitoneum pressure required to obtain an adequate surgical view?
- Does either bowel preparation method cause more discomfort or side effects before surgery?
Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery.
Participants will:
- Be randomly assigned to receive either a standardized 3-day bowel preparation protocol or a rectal enema before surgery.
- Undergo standard laparoscopic surgery for endometrial cancer.
- Have surgical exposure, the minimum Trendelenburg position, the minimum pneumoperitoneum pressure, operative outcomes, postoperative recovery, and bowel preparation-related symptoms and discomfort assessed as part of routine clinical care.
Detailed description
Adequate bowel preparation is important for achieving optimal surgical exposure during laparoscopic surgery for endometrial cancer. Inadequate bowel preparation may impair visualization of the operative field, requiring steeper Trendelenburg positioning and higher pneumoperitoneum pressures, which may increase the physiological burden of surgery and affect operative performance.
Mechanical bowel preparation with rectal enema is commonly used before gynecologic surgery, although its routine use remains controversial because evidence supporting its clinical benefit is limited. A standardized 3-day bowel preparation protocol may improve patient tolerance while maintaining adequate surgical conditions. However, prospective randomized studies comparing these two approaches specifically in laparoscopic endometrial cancer surgery remain limited.
This prospective randomized controlled trial will compare a standardized 3-day bowel preparation protocol with a preoperative rectal enema before laparoscopic surgery for endometrial cancer. The primary objective is to determine whether the dietary bowel preparation protocol can provide surgical conditions comparable to those achieved with rectal enema.
In addition to subjective assessment of surgical exposure, the study will evaluate objective intraoperative parameters, including the minimum Trendelenburg position and the minimum pneumoperitoneum pressure required to maintain an adequate surgical view. Operative outcomes, postoperative recovery, patient tolerance of the bowel preparation methods, and bowel preparation-related symptoms will also be evaluated.
The findings of this study may help optimize preoperative bowel preparation strategies, reduce unnecessary patient burden, and support evidence-based perioperative care for patients undergoing laparoscopic surgery for endometrial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either a low-residue diet or a rectal enema before surgery. Group allocation will be performed using a computer-generated randomization list with sequentially numbered opaque envelopes. Operating surgeons assessing the intraoperative primary outcomes will remain unaware of treatment allocation until completion of the intraoperative assessment.
| Arm | Type | Receives |
|---|---|---|
| Low-Residue Diet | Experimental | Behavioral: Low-Residue DietParticipants will follow a standardized 3-day bowel preparation protocol before surgery. The protocol includes a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery |
| Rectal Enema | Active comparator | Drug: Sodium Phosphate Rectal EnemaParticipants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the institutional bowel preparation protocol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female participants aged 18 to 90 years.
- Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
- Willing and able to provide written informed consent.
Key exclusion criteria (4 listed)
- Planned open (abdominal) surgery.
- Known allergy or contraindication to sodium phosphate rectal enema.
- Age over 90 years.
- Refusal or inability to provide written informed consent.
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 |
|---|---|---|
| Low-Residue DietParticipants will follow a standardized 3-day bowel preparation protocol consisting of a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery, with adequate hydration throughout the preparation period. | Behavioural | Low-Residue Diet |
| Sodium Phosphate Rectal EnemaParticipants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the manufacturer's instructions and the institutional bowel preparation protocol. | Drug | Rectal Enema |
Primary outcome
Intraoperative Visual Index Score
Time frame: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar
Surgical exposure will be assessed intraoperatively using the Visual Index score after establishment of pneumoperitoneum and placement of the camera trocar and one lateral ancillary trocar. The score ranges from 0 to 2, where 0 indicates inadequate visualization despite bowel retraction with one grasper, 1 indicates adequate visualization requiring bowel retraction with one grasper, and 2 indicates adequate visualization without bowel retraction. Higher scores indicate better surgical exposure.
Minimum Trendelenburg Position Required for Adequate Surgical Exposure
Time frame: Intraoperatively
The minimum Trendelenburg angle (degrees) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Minimum Pneumoperitoneum Pressure Required for Adequate Surgical Exposure
Time frame: Intraoperatively
The minimum pneumoperitoneum pressure (mmHg) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
4 secondary outcomes
Operative Time
Time frame: During surgery
Length of Hospital Stay
Time frame: At hospital discharge, assessed up to 30 days after surgery
Time to First Flatus
Time frame: From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days
Patient Tolerance of Bowel Preparation
Time frame: From preoperative bowel preparation until postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, together with a data dictionary, will be made available upon reasonable request to the corresponding investigator. Data will be shared only after publication of the primary study results and subject to institutional approval, a scientifically sound research proposal, and execution of a data use agreement. Additional data may be considered on a case-by-case basis at the discretion of the principal investigator.
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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.
Mahmut Yassa, MD principal investigator
Başakşehir Çam & Sakura City 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 Low-Residue Diet and Sodium Phosphate Rectal Enema in people with Endometrial Cancer, run by Mahmut Yassa 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmut Yassa, MD (+90 539 663 54 84, mahmut_yassa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Visual Index Score (time frame: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar). The study lists 3 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 17 Jul 2026.