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NCT Number: NCT07702799

Low-Residue Diet Versus Rectal Enema Before Laparoscopic Surgery for Endometrial Cancer

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.

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Key information

Conditions

Endometrial Cancer Digestive System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Peritoneal Diseases Pneumoperitoneum Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bora Taşpınar, MD

SUB_INVESTIGATOR

mahmut yassa

CONTACT

[email protected]

+905396635484

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 18 to 90 years.
  • Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
  • Willing and able to provide written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Operative Time

    Time frame: During surgery

    Total operative time measured from skin incision to skin closure, recorded in minutes.

  2. Length of Hospital Stay

    Time frame: At hospital discharge, assessed up to 30 days after surgery

    Length of postoperative hospital stay, measured in days from surgery until hospital discharge.

  3. Time to First Flatus

    Time frame: From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days

    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.

  4. Patient Tolerance of Bowel Preparation

    Time frame: From preoperative bowel preparation until postoperative day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmut Yassa, MD

CONTACT

[email protected]

+90 539 663 54 84

Sponsors and collaborators

Lead sponsor

Mahmut Yassa

Other Gov

Registry information

Official study title

Low-Residue Diet Versus Rectal Enema Before Laparoscopic Endometrial Cancer Surgery: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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