Low-Residue Diet Versus Rectal Enema Before Laparoscopic Surgery for Endometrial Cancer
ConditionEndometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorMahmut Yassa
About this 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:
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 18 to 90 years.
Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
Willing and able to provide written informed consent.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Low-Residue Diet
BehavioralParticipants 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 Enema
DrugParticipants 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Low-Residue DietExperimental treatment 1 intervention
Group B: Rectal EnemaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar2
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.
Time frame
Intraoperatively3
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.
Time frame
IntraoperativelySecondary outcomes
1
Operative Time
Total operative time measured from skin incision to skin closure, recorded in minutes.
Time frame
During surgery2
Length of Hospital Stay
Length of postoperative hospital stay, measured in days from surgery until hospital discharge.
Time frame
At hospital discharge, assessed up to 30 days after surgery3
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.
Time frame
From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days4
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.
Time frame
From preoperative bowel preparation until postoperative day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mahmut Yassa
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Sponsor institution
Source ClinicalTrials.gov