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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:
Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Residue Diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Total operative time measured from skin incision to skin closure, recorded in minutes. | During surgery |
| Length of Hospital Stay | Length of postoperative hospital stay, measured in days from surgery until hospital discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmut Yassa, MD | Contact | +90 539 663 54 84 | mahmut_yassa@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mahmut Yassa, MD | Başakşehir Çam & Sakura City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başakşehir Çam and Sakura City Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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.
Beginning 6 months after publication of the primary study results and ending 3 years after publication.
Access will be considered for qualified researchers conducting scientifically sound research. Requests must include a research proposal and, where appropriate, a statistical analysis plan. All requests will be reviewed by the principal investigator and approved according to institutional policies. Approved researchers will be required to sign a data use agreement before receiving de-identified data.
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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.
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Because of the nature of the interventions, participants and the study nurse responsible for preoperative bowel preparation cannot be blinded. Operating surgeons assessing the intraoperative primary outcomes will remain unaware of treatment allocation until completion of the intraoperative assessment. Postoperative data collection and statistical analyses will be performed by the study investigators.
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| Sodium Phosphate Rectal Enema | Drug | 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. |
|
| 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. | 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. | From preoperative bowel preparation until postoperative day 1 |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |